Abstract of thesis entitled. An evidence-based pelvic floor muscle training program to reduce urinary

Transcription

1 Abstract of thesis entitled An evidence-based pelvic floor muscle training program to reduce urinary incontinence for patients undergoing transurethral resection of prostate Submitted by Leung Pui Ngan Connie for the degree of Master of Nursing at The University of Hong Kong in July 2014 Transurethral resection of prostate is a golden standard treatment for benign prostate hypertrophy. However, urinary incontinence is a common phenomenon of patients after operation. It gives great impact to their quality of life. With the development evidence-based practice in nursing, nurse translates the best evidence into practice to reduce urinary incontinence for patients undergoing transurethral resection of prostate. Pelvic floor muscle training is a safe and a conservation treatment to reduce urinary incontinence for patients undergoing operation. It reduces the social and health burden as well as to promote the development of professional nursing care in Hong Kong.

2 This thesis is to develop an evidence-based guideline for patients to practice pelvic floor muscle training to reduce urinary incontinence undergoing the transurethral resection of prostate. Systematic literature search were performed to extract valid articles, finally six articles were selected. Scottish Intercollegiate Guidelines Network (SIGN) checklist was applied to assess quality of each study. The target audiences of the pelvic floor muscle training program are patients planned to have elective transurethral resection of prostate at least two weeks before operation. It is proposed to implement in a day and a urology wards of an acute hospital. The high implementation potential of the program is estimated after examination of the local transferability, feasibility and cost-benefit ratio. An evidence-based practice guideline is developed to deliver the best quality of nursing care to patients undergoing transurethral resection of prostate. To facilitate implementation of the program, a tailor-made pilot study with implementation and evaluation plans are elaborated.

3 An evidence-based pelvic floor muscle training program to reduce urinary incontinence for patients undergoing transurethral resection of prostate by Leung Pui Ngan Connie RN, RNM, BSc (Nursing), MSc (AIM) A thesis submitted in partial fulfillment of the requirements for the Degree of Master of Nursing at The University of Hong Kong July 2014

4 Declaration I declare that this thesis represent my own work, except where due acknowledgement is made, and that is has not been previously included in a thesis, dissertation or report submitted to this University or to any other institution for a degree, diploma or other qualification. Signed. Leung Pui Ngan Connie i

5 Acknowledgements I would like to thank my supervision, Dr. Denise Chow, who gave me guidance and support in this thesis. Her generous assistance enabled me to complete the thesis. Also, I would like to express my gratefulness to my classmates, who support and encourage me to get through the difficult times throughout my period of study. Finally, I want to express my warmest gratitude to my husband and family for their patience and support throughout these two years. ii

6 Contents Declaration... i Acknowledgements... ii Contents... iii Chapter 1 Introduction Background Affirming the Need Research Question Aims and Objectives Significance of the Study... 7 Chapter 2 Critical Appraisal Search Strategy Appraisal Strategies Results Chapter 3 Translation and Application Implementation Potential Transferability of the Findings Feasibility Cost-benefit Ratio of the innovation Evidence-Based Practice Guideline Chapter 4 Implementation Plan Communication Plan Pilot Study Plan iii

7 4.3 Evaluation Plan Chapter 5 Conclusion List of Appendices Appendix 1: Search Strategies and Result Appendix 2: Table of the Scottish Intercollegiate Guidelines Network (SIGN) Grading System Appendix 3: Tables of Evidence Appendix 4: Methodology Checklists Appendix 5: Summary of Levels of Evidence Appendix 6: Summary of Quality Assessment of the Selected Studies Appendix 7: Summary of the Data of the Selected Intervention Studies Appendix 8: Recommendation from Synthesis Process Appendix 9: Summary of Recommendation from Reviewed Studies Appendix 10: ICIQ-UI Short Form Appendix 11: The Chinese Version of the ICIQ-UI Short Form Appendix 12: Nurses Evaluation Form for Self-perceived Skills and Knowledge and Satisfaction Level Appendix 13: A Permission Letter for the use of ICIQ-UI Short Form References iv

8 Chapter 1 Introduction Benign prostatic hypertrophy (BPH) is a non-malignant enlargement of the prostate gland, commonly found in men over the age of 50 (Roehrborn & McConnell, 2002). Currently, transurethral resection of prostate (TURP) is the most common and a golden standard treatment for BPH (Paolone, 2010; Rassweiler, et al., 2006; Sun, 2005). However, % of the patients suffered from urinary incontinence after TURP (Lourenco et al., 2008; Rassweiler et al., 2006). Urinary incontinence may have great impact on their quality of life and imposed burden to the health care system. Pelvic floor muscle training (PFMT) is a safe, feasible and conservation management for urinary incontinence after TURP. With the professional nursing care, the social and health burden will be greatly reduced. Although there are a lot of empirical evidences and clinical practices supporting the PFMT in patients after prostactectomy (Bauer et al., 2009), a guideline or protocol of PFMT for patients undergoing TURP in local clinical setting is lacking. The purpose of this translational research is to translate the best evidence into practice to prevent or reduce the urinary incontinence of patients underwent TRUP by PFMT. 1

9 1.1 Background Benign prostatic hypertrophy (BPH) is a non-malignant enlargement of the prostate gland, one of the most commonly disease in men over the age of 50. Prostate becomes larger in most men as they get older. Based on the several autopsy studies, about 50-60% of men in their 60s, and 80-90% of men in their 70s and 80s with enlarged prostate (Roehrborn & McConnell, 2002). In the 2011 Population Census, the life expectancy for men in Hong Kong was 80 years. Of the 7.07 million populations in Hong Kong, 13.3% (438,257) of men were 65 years old or above (Census and Statistics Department, 2012). In a local community survey amongst men in age in 2003, 16% of Hong Kong men had moderate to severe lower urinary tract symptoms (Ngai, 2004). Nowadays, there are different options to treat BPH such as conservative methods, drug treatment. For moderate to severe lower urinary tract symptoms secondary to benign prostate hyperplasia, surgical treatment must be considered if the medical therapy is fail to response. In surgical treatment, TURP is a golden standard for BPH givens its long-term efficacy established in clinical studies 2

10 (Paolone, 2010; Rassweiler et al., 2006; Sun, 2005). After successful surgery, 0.6% to 40% of patients may suffer from temporary urinary incontinence in early post-operatively period (Lourenco et al., 2008; Rassweiler et al., 2006). The International Continence Society defines urinary incontinence is a storage symptom with the complaint of involuntary loss of urine (Abrams et al., 2009). Urinary incontinence is a distressing condition that may have great impact on patient s quality of life. It associated with low self-esteem, social anxiety and depression if persistent incontinence cannot be managed. An unexpected increased societal cost in seeking health care services and increased need for nursing home care will be anticipated (Glazener et al., 2011a). Pelvic floor muscle training (PFMT) is a first-line conservative management method for urinary incontinence (Harris, 1997). It is a safe, non-invasive behavioural treatment. It is performed by repeated contraction and relaxing the pubococcygnus muscles of the pelvic floor to increase its contractility of the distal urethral sphincter. PFMT is a recommended first-line treatment for early incontinence that follows prostatectomy within the first 6-12 months (Bauer et al., 2009). 3

11 1.2 Affirming the Need In view of the ageing population and increasing life expectancy men in Hong Kong, urinary incontinence related to the post TURP will be increasing in future. Currently, TURP is a standard golden operation for BPH; 2365 TURP were done in Hospital Authority hospitals in Hong Kong in the year of 2010 (Man, 2011). Since the urinary incontinence is usually temporary and it is not a life-threatening issue after TURP, the prevalence is not well reported in clinical practice. Also, the outcomes of medical and surgical treatments are usually evaluated in long-term observation (Willener, Spichiger & Hantikainen, 2008). I am currently working in a urology ward of a public hospital in Hong Kong. TURP is the most common operation in a urology ward. By the retrospective clinical observation from September 2012 to August 2013, there were 15 patients underwent TURP per month. According to the above studies, 0.6% to 40% of patients with urinary incontinence after TURP, then 0.1 to 6 patients per month will suffer from it. Also, nurses received telephone enquiry of average 4 patients per month about various degree of urinary incontinence after TURP by retrospective clinical record from July to August This prevalence presents 4

12 a substantial health concern in my working area. A preliminary search of the available evidences on management measures for urinary incontinence after TURP was carried out. The measures include supervised PFMT, drug therapy and surgical intervention (Heath & Watson, 2002; Miller & Miller, 2011; Thuroff et al., 2011). In clinical practice, we can provide PFMT before operation and remind patients to do it after discharge to help them to regain continence earlier. Nowadays, there is still lacking of standardization of the most effective PFMT protocol. There are conflicting evidences in using biofeedback or electrical stimulation together with PFMT. Also, the identification of the initiation time for PFMT either before or after operation is needed. The content, frequency and duration of the PFMT is also being identified. There is a strong need to conduct an extensive review of well-designed studies to evaluate the different types of interventions and to develop an evidence-based PFMT program for patients after TURP in local clinical setting. Urinary incontinence may have great impact on quality of life of patients. It 5

13 must be anticipated earlier to prevent any social isolation or depression of patients. Nurses must play a vital role to promote earlier recovery of patients by attending physical, psycho-social needs of patients. It will greatly reduce the health care and social burden. 1.3 Research Question From the above discussion of the background and the need of the evidence-based practice on this topic, the research question of this study is In patients underwent transurethral resection of prostate, how does the pelvic floor muscle training compare to without training affect the post-operative urinary incontinence? 1.4 Aims and Objectives The aim of this study is to develop an evidence-based pelvic floor muscle training program to reduce urinary incontinence for patients undergoing transurethral resection of prostate. The objectives of this study are: (1) To review the current literatures systematically for the effectiveness of the PFMT for urinary incontinence after TURP; 6

14 (2) To extract data from the selected studies and compile it into the table of evidence; (3) To perform quality assessment of the selected studies; (4) To identify the best evidence, feasibility and transferability of the PFMT to the target patients in local setting. (5) To develop an evidence-based practice protocol for quality care of patients undergoing TURP in reducing severity and duration of the urinary incontinence. 1.5 Significance of the Study Urinary incontinence is a distress commonly after TURP. It threatens patients quality of life and result of social anxiety and isolation. It is worthy to build an evidence-based pelvic floor muscle training protocol which will benefit to the patients, health care professionals and the hospital. For patient, by practicing the PFMT, they can regain urinary continence earlier and improve quality of life without taking any medication and operation. It greatly improves their physical and psycho-social well beings. Also, it can reduce their expenses and trouble in using incontinence pads. 7

15 For nurses, provide an evidence-based pelvic floor muscle exercises program to patient undergoing TURP is a health care concern. Through the program development and implementation, nurses can gain more autonomy and confidence in nurse led education program as well as the evidence-based protocol. PFMT is a non-invasive nursing intervention; it is the best opportunity for nurses to develop their role in their profession. For health care organization, health care professionals provide safe evidence-based practice can build her reputation and reduce the financial burden as well as the social burden to handle the complaints of urinary incontinence from patients. 8

16 Chapter 2 Critical Appraisal After formulated the research question, aims and objectives of the study; and affirming the need and significance of developing an evidence-based pelvic floor muscle training program in the local clinical setting, this chapter is going to discuss the searching and appraisal strategies to identify the best evidence to support the development of the new guideline. 2.1 Search Strategy Selection criteria Inclusion criteria For the participants, men with BPH, who have undergone a TURP and have PFMT intervention by health care professionals. The PFMT with and without biofeedback, electrotherapy, and behavioural therapy are included. They must be cognitive intact and able to understand the instructions. There is no limitation in age, continence status and dependence on activity level. For the types of studies, this review considered randomized controlled trials (RCT) those report the incidence of doing PFMT before and after TURP. For the 9

17 outcome measures, the primary outcomes are the incidence of urinary incontinence and urinary symptoms; the secondary outcomes are the quality of life and the strength of pelvic floor muscle. Exclusion criteria Men were planned or receiving bradytherapy, with urethral or pelvic surgery, suffering from neurological diseases or cognitive impairment Keywords The keywords for searching were prostate, urinary incontinence, pelvic floor, transurethral resection of prostate, benign prostate hyperplasia and pelvic floor muscle exercise Search methodology A search of literature was conducted on 18 August 2013, a systematic four-step searching were utilized in this study. An initial search from the above keywords via CINAHL Plus, PubMed, Science Direct and British Nursing Index databases was done. Keywords and various combinations of them were used. All the searches were limited the inclusion and exclusion criteria; and published on 10

18 or after January There was no language limitation. From the CINAHL Plus database, only one study was yielded. In PubMed database, 17 studies were yielded. In Science Direct, 112 studies were yielded. In British Nursing Index, 8 studies were yielded. A second search, analysis of content in the title and abstract against inclusive and exclusive criteria were done. One study from the CINAHL Plus, 6 out of 17 studies from PubMed, 2 out of 112 studies from Science Direct and 2 out of 8 studies from British Nursing Index were selected. After reading the content of the studies, two studies were duplicated (Glazener, et al., 2011a & 2011b) and one study was eliminated due to it only involved one subject underwent TURP (Joseph, 2000). Then, 6 randomized controlled trials were selected from these databases searching. Thirdly, clinical guideline searching was performed in the Scottish Intercollegiate Guideline Network (SIGN), National Guideline Clearinghouse (NGC), and American Urological Association (AUA) Guidelines, National Institute for Clinical Excellence (NICE) and European Association of Urology (EAU) guideline. However, neither was specific in management of the urinary 11

19 incontinence after TURP. Fourthly, the reference list of all related articles were screened with no more additional article was found. Finally, six randomized controlled trials (RCT) in English were selected in this review. The table of search strategy and result in these databases was shown in Appendix Appraisal Strategies Data of the above selected six studies were extracted and recorded in form of a table of evidence. An evidence table for intervention studies by the Scottish Intercollegiate Guidelines Network (SIGN) was used. It included data on bibliographic citation, study design and level of evidence, subject characteristics, number of participants, dropout rate, intervention, comparison, data collection time, outcome measures and effect size. Level of evidence of each study was graded according to the SIGN (2013a) grading system which was shown in Appendix 2. For quality assessment of the selected six studies, a methodology checklist for randomized controlled trials of SIGN (2013b) was used to guide the 12

20 assessment. The tables of evidence and methodology checklists of six studies were shown in Appendix 3 and 4 respectively. 2.3 Results After a systematic four-step searching of literature conducted on 18 August 2013, six studies were selected. Five studies were RCTs (Glazener et al., 2011a; Hou et al., 2013; Ip, 2004; Porru et al., 2001; Tibaek et al., 2007) and one was controlled trial (Chang et al. 1998). All were in English and published between 1998 and Data of all studies were extracted and illustrated in the form of table of evidence according to the SIGN 50: a guideline developer s handbook (SIGN, 2013a). The table of evidence of each intervention study was showed in Appendix Summary of levels of evidence The levels of evidence of the six selected studies ranged from 1++ to 2++. For the five randomized controlled trials, the level of evidence of Glazener et al. (2011a) was 1++, Porru et al. (2001) and Tibaek et al. (2007) were 1+, Hou et al. (2013) and Ip (2004) were 1-. For the controlled trial, the level of evidence was 2++ (Chang et al., 1998). Summary of levels of evidence of selected studies was 13

21 shown in Appendix Summary of quality assessment The critical appraisal checklist of Scottish Intercollegiate Guidelines Network (SIGN, 2013b) - methodology checklist 2: controlled trials was used to assess quality of the six selected studies (Chang et al., 1998; Glazener et al., 2011a; Hou et al., 2013; Ip, 2004; Porru et al., 2001; Tibaek et al., 2007). Individual checklist for each study was shown in Appendix 4. Finally, a table of the summary of quality assessment of the selected studies was shown in Appendix 6. All selected six studies addressed clearly and appropriately on focused research question and provided details of the intervention and comparison groups, and the measured outcomes for their research objectives. Five selected trials were randomized controlled trails. Only two trials included an adequate method of random group allocation and described allocation concealment. Remote computer randomization and allocation was described in Glazener et al. (2011a). Randomization by grouping in blocks of ten 14

22 of a mathematical table, and sealed in envelops by independent third party was mentioned in Tibaek et al. (2007). Chang et al. (1998) allocated the groups by preceding and subsequent men without randomization, this study should be a controlled trial. Most of the trials were not describe blinding. Due to the nature of the intervention, blinding of the therapists, assessors and patients were not possible, the risk of bias was not counted. However, three trials had made effort to minimize bias by getting data entry. In Glazener et al., (2011a), data was entered by clerks blinded to group. In Tibaek et al. (2007) and Porru et al. (2001), an independent physiotherapist or urologist did initial and outcome pelvic floor assessment respectively. There were no significant between groups difference in baseline in all trials except the one trial (Ip, 2004). It did not mention any demographic data of subjects in both groups; it mentioned the incontinence state and score only. For the equality of treatment and control groups being investigated, all groups were investigated equally in all studies. For the outcome measures, all 15

23 relevant outcomes were measured in a standard and reliable way in all selected studies except the one study (Ip, 2004). Her outcomes were not presented in a statistically measures. All studies reported the acceptable dropout rate; they ranged from 0% to 15.52%. All of them gave explanation or reasons of any withdrawals or dropouts. Intention to treat analysis was applied in all studies except two studies with zero dropout rates (Chang et al., 1998; Ip, 2004). All studies were carried in one site only except a study by Glazener et al. (2011a). Subjects were recruited from 34 UK centers, confidence of the result was increased and comparable for all sites. The overall methodological quality of the studies to minimize bias ranged from low quality to high quality. Two studies (Glazener et al., 2011a and Tibaek et al. 2007) were high quality with little or no risk of bias. Three studies (Chang et al., 1998; Hou et al and Porru et al. 2001) were acceptable quality with associated risk of bias in missed criteria. One study (Ip, 2004) was low quality. It might be the study was terminated prematurely due to change of clinical 16

24 operation Summary and synthesis of data (1) Study characteristics For the locations of the studies, two were conducted in Taiwan (Chang et al., 1998; Hou et al., 2013). Other studies were conducted in different countries, United Kingdom (Glazener et al., 2011a), Australia (Ip, 2004), Italy (Porru et al., 2001) and Denmark (Tibaek et al., 2007). For the sample size of the intervention studies, four medium trials of subjects ranged from (Chang et al., 1998; Hou et al., 2013; Porru et al., 2001; Tibaek et al., 2007); one large trial of 442 subjects in 34 UK centers (Glazener et al., 2011a) and one small trial of 16 subjects (Ip, 2004). Total 640 subjects participated in these studies. For the subject characteristics, all trials included patients underwent TURP who aged between 45 and 79 and did not undergo bradytherapy. In Glazener et al. (2011a), it consisted of two studies, one was men with radical prostatectomy, and another was men with transurethral resection of prostate. In this thesis, the study 17

25 of TURP in Glazener et al. (2011a) was considered. Five studies included men without urinary catheter after operation (Chang et al., 1998; Glazener et al., 2011; Hou et al., 2013; Porru et al., 2001; Tibaek et al., 2007) while one included men with urinary catheter after operation (Ip, 2004). For study purpose, all studies investigated the effectiveness of the PFMT intervention. In addition of it, one study compared the effectiveness of intervention between a visual reminder, refrigerator magnet, and a paper reminder in PFMT (Ip, 2004); another one study investigated the use of Short Form-36 Health Survey scale (SF-36) to assess the effect of PFMT (Hou et al. 2013); one study investigated the cost-effectiveness of one to one intensive PFMT as well (Glazener et al., 2011a). For comparison, four studies continued usual activity without any PFMT was taught in control groups (Chang et al., 1998; Glazener et al., 2011a; Hou et al., 2013; Porru et al., 2001); one study provided information and verbal instruction of PFMT only after operation, without any individual or group teaching of PFMT program in control group (Tibaek et al., 2007). A study provided same PFMT information to both intervention and control groups, but in 18

26 different form with the magnet and paper reminder to the respective groups (Ip, 2004). For the dropout rates of the selected trials ranged from 0% to 15.52%. Four studies dropout rates were below 10% (Chang et al., 1998; Hou et al., 2013; Ip, 2004; Porru et al., 2001) whereas two studies were 10% to 15.52% (Glazener et al., 2011a; Tibaek et al., 2007). (2) Assessment and outcome measures In the assessment and outcome measures, there was a lack of consistency in the selected studies. A summary of the results was shown in Appendix 7. For the primary outcomes, they included the urinary incontinence status and lower urinary tract symptoms. Two trials with evidence levels 1+ and 2++ for men post-turp showed significant improvement in urinary incontinence after 4 weeks of PFMT (Chang et al., 1998; Porru et al., 2001). Only one trial with evidence level 2++ (Chang et. al., 1998) for terminal dribbling, it was significant improved after PFMT for 4 weeks. Three trials with evidence levels ranged from 1+ to 2++ showed significant improvements in urinary symptoms in objective uroflowmetry parameter - maximum urinary flow rate (Q max), and 19

27 total and storage score of International Prostate Symptom Score (IPSS), and improvement of voiding interval in voiding diaries recording (Chang et al., 1998; Hou et al., 2013; Porru et al., 2001). In Ip (2004), no significant different in incident of urinary incontinence might be due to small subject size and premature call off of study because of operation changes. In Glazener et al. (2011a), evidence level 1++, the International Consultation on Incontinence Questionnaire Urinary Incontinence, short form (ICIQ-UI SF) was used for screening of the urinary incontinence status of patients. It showed no significant different because the subjects were recruited after six weeks after operation and first data collection period at three months after operation. Reviewed from the significant results from other studies, most of the significant different in incontinent status and urinary symptoms occurred in about four weeks after training or operation. Also, the high rates (64.9% of intervention group and 61.6% of control group) of persistent incontinence after 12 months suggested of unrecognized complication after operation. According to the National Guideline Clearinghouse (2009), further investigation and treatment were suggested for patients failed after 6-12 months of first-line conservation management by 20

28 PFMT. For secondary outcomes of pelvic floor muscle strength and quality of life, three trials with evidence levels ranged from 1+ to 2++ showed significant strengthening of pelvic floor muscle by using digital anal grading with the modified Oxford scale after 4 weeks (Chang et al., 1998; Porru et al., 2001; Tibaek et al., 2007). Another two trials did not assess pelvic floor muscle strength (Hou et al., 2013; Ip, 2004). In Glazener et al. (2011a), there was no significant different in the pelvic floor muscle strength was found compared with no PFMT group after 3 months of PFMT. However, all subjects showed great fall of proportion with incontinence from 82% to 52% after 3 months of intervention. It may show that urinary incontinence is a temporary state after TURP. Meanwhile, the review of this study commented the PFMT information was widely available in the internet and study area, about 21% in both control and intervention group subjects had practiced PFMT before randomization even though without formal teaching by health care professionals. Also, the pelvic floor muscle strength was measured in intervention groups only; statistically significant between groups 21

29 would not be determined. For assessing the subjective impact on quality of life by urinary incontinence in selected studies, they used different measuring tools without any consensus. Four studies used three urinary symptoms measuring tools - International Prostate Symptom Score (IPSS), American Urological Association Symptom Index (AUA-SI) and Danish Prostatic Symptom Score (DAN-PASS-1) because all three tools with a separate quality of life score in the questionnaire (Chang et al., 1998; Hou et al., 2013; Porru et al., 2001; Tibaek, et al., 2007). No study showed significant different in this area as they were not sensitive to the urinary incontinence subjects. Similarly, two studies used two incontinence tools ICIQ-UI SF and St. George urinary incontinence score; there was one question about quality of life (Glazener et al., 2011a; Ip, 2004). Finally, both studies did not show any significant different result after intervention. On the other hand, general health questionnaire with physical, mental, psycho-social dimensions showed significant improvement after PFMT in 3 22

30 studies with evidence levels ranged from 1+ to 2++. The Short Form Health Survey scale (SF-36) was used in Hou et al. (2013) showed significant improvement in both physical and mental dimensions after 12 weeks of PFMT. The Patient satisfaction score in Chang et al. (1998) showed significant improvement in total score and psychological and social dimensions after 4 weeks of PFMT. The ICS male questionnaire showed significant improvement after 4 weeks of PFMT (Porru et al., 2001). The European Quality of Life -5 Dimensions (EQ-5D) and Short form-12 health survey (SF-12) were used in Glazener et al. (2011a), no significant was found at 6 and 12 months after interventions. General health questionnaires were more sensitive for urinary incontinence men in assessing their quality of life when compared to urinary symptoms specific questionnaires. Similarly, two studies did not assess it (Ip, 2004; Tibaek et al., 2007). In Glazener et al. (2011a), there was no significant difference in both types of questionnaires in quality of life between the intervention and control groups. However, the men showed a gradual improvement over time in their quality of life as showed in the mean ICI-Q score and measures in their quality of life dimensions in EQ-5D and SF-12 in 3, 6 and 12 months of reviews. It might hint 23

31 that men undergo gradual recovery from the operation. For assessing the health economic outcomes by the incremental cost per quality-adjusted life-year (QALYS) in a study of Glazener et al. (2011a), it showed significant different between the intervention and control group after 12 months of intensive PFMT. 3. Interventions In PFMT regime, all studies except one study (Ip, 2004) included an initial individual assessment of pelvic floor muscle tone by digital anal examination as Ip (2004) did not mention the mode of delivery of PFMT in details. Only one individual session for PFMT in four studies showed more significant different results in pelvic floor muscle strength, incidence of urinary incontinence, urinary symptoms and general measures of quality of life (Chang et al., 1998; Hou et al., 2013; Porru et al., 2001) compared to multiple individual or group teaching sessions by therapists in two studies (Glazener et al., 2011a; Tibaek et al., 2007). Four studies with evidence levels ranged from 1+ to 2++. For initiation time of PFMT, men showed earlier significant regaining 24

32 continence in 1, 2, 3 weeks and significant lengthen voiding interval after 2 and 3 weeks operation in a pre-operative trial with evidence level 1+ (Porru et al., 2001). In post-operative trials, men showed significant regaining continence after practicing PFMT in 3 weeks onwards (Chang et al., 1998); men showed significant improvement in urinary symptoms presented in IPSS in 4 weeks after PFMT (Hou et al., 2013). That is, men will regain continence or improvement of urinary symptoms by practicing PFMT earlier before operation. In the pre-operative study of Tibaek et al. (2007), it showed no significant different in pre and post-operative initiation of PFMT. It may be explained that the only one teaching session before operation was not enough for elderly to catch up the technique, and the exact duration before operation for intervention was not mentioned in the study as it may greatly affect the recovery time after PFMT. For the PFMT content, there was no consensus in six selected studies. But they exhibited several common characteristics. They must include daily home practice, slow contraction in 3 positions, and the knack, tighten the pelvic floor muscle strongly after voiding. PFMT with 1-6 times per day, 6-10 series of 25

33 3-15 slow contractions (evidence levels ranged from 1++ to 2++). After that, patients motivation and compliance are the critical criteria for successful outcome. Biofeedback was used in two studies. One study was Glazener et al. (2011a), evidence level 1++, only 13 of 220 men used biofeedback in this study; another study was Hou et al. (2013), evidence level 1+, a surface electromyogram (EMG) was applied to confirm patients doing correct PFMT, no measurement of pelvic floor muscle strength was performed. In local setting, the use of biofeedback is optional depends on its availability. For the types of therapists, there was only one trial with evidence level 1++ for different disciplines of therapists comparison, physiotherapists and continence nurses (Glazener et al., 2011a). It did not show any statistically significant differences in the attendance of therapeutic sessions or mean incontinence scores as both disciplines exhibited standard training in the study. For education tools, all studies included the verbal or in addition of written instructions for home exercise as they were the basic educational tools. In the 26

34 study of Ip (2004), evidence level 1-, used a refrigerator magnet as a visual reminder for exercise to compare the paper copy, the result was inconclusive due to small sample size from premature call off. However, the patients appreciated it was a good idea for reminder. For the bladder training and lifestyle leaflet in addition of PFMT, they were suggested in two trials (Glazener et al., 2011a; Ip, 2004). But they were not investigated in these two studies. 4. Period of follow-up sessions and data collection methods All studies collected data at baseline and intermittent periods after interventions. Teaching classes, clinical visits, telephone follow up, or postal questionnaire were used to monitor and record patients progress and their compliance. The duration ranged from weekly in first four weeks and up to 12 months. After reviewing the selected studies, follow-up or data collection in four weeks and 12 weeks got the most significant different results Recommendations After the critical review of the evidence, benefits of PFMT and incidence of 27

35 regaining urinary continence was demonstrated in some selected studies, it was helpful to draw out recommendations. Appendix 8 showed tables of recommendation from synthesis process. (1) Target group will be men with BPH and had undergone TURP. They were not planned or received bradytherapy. They did not have urethral or pelvic surgery; and not suffering from neurological diseases or cognitive impairment. They can be communicated and understood the therapists instruction for PFMT. (2) Assessment and outcome measures The ICI-UI SF and voiding diary were recommended assessment tools for urinary incontinence. The AUA-SI and IPSS were similar in meaning with the identical grading method, either one of them was recommended to use in assessing severity of urinary symptoms. Voiding and storage parameters by uroflowmetry and bladder scan were suggested to quantity the severity of urinary symptoms and to monitor patients progress of treatment. Modified Oxford Scale was recommended to assess the pelvic floor muscle strength. For generic health assessment, physical, psycho-social and emotional dimensions 28

36 were recommended. A commonly used, well-validated with a Chinese version of questionnaire is the major chosen criteria for the local study. (3) Intervention An individual baseline assessment and teaching session was recommended. PFMT was suggested to start as soon as possible before surgery to help patients regain continence earlier. In regime of PFMT, strong contractions in lying, sitting and standing positions, the knack and tightening the pelvic floor muscles strongly after voiding were recommended. Nurses with specialized experience in incontinence will be recommended as therapist as they will follow-up patients from pre-operative to post-operative and provide an integrated care planning and related home advice to patients as a whole. Verbal and written instructions for home exercise, a visual reminder such as a refrigerator magnet was recommended to increase PFMT compliance. In addition of PFMT, bladder training and lifestyle leaflet were suggested. (4) Duration and mode of follow up sessions Follow up at 2, 4 and 12 weeks after operation or discharge was 29

37 suggested to monitor their progress and to increase their compliance of PFMT. In local setting, the duration and mode of follow-up will greatly depend on the availability of the manpower and budget. Multiple teaching follow up sessions can be applied to the setting with the information of PFMT is not widely available in the society or targeted to special age group - elderly. Elders are not easily catch up the technique of contractions without professional health care instruction. 30

38 Chapter 3 Translation and Application After reviewed and identified the best practices, this chapter is going to discuss the implantation potential, transferability of the findings and feasibility of the reviewed studies in local clinical setting. Then, an evidence-based practice guideline of pelvic floor muscle training program is introduced. 3.1 Implementation Potential The proposed program is the pelvic floor muscle training (PFMT) program to reduce urinary incontinence for patients undergoing transurethral resection of prostate (TURP). In the above review, it is shown that the PFMT program can reduce urinary incontinence and increase quality of life in men after TURP. This effective program is proposed to be translated into local practice. Before implementation, the target setting and audience, the transferability of the findings, feasibility and cost-benefit ratio of the proposed program will be examined. 31

39 3.1.1 Target setting The proposed pilot PFMT program will be implemented in a 42 beds urology in-patient ward and a 31 beds day ward in an acute hospital under the Hospital Authority Target audience The target audiences of the innovation are all patients who are scheduled for elective TURP within at least one week before operation and have pre-operative assessment (PAS) in day ward as they will have sufficient time for exercise education and practicing at home before operation. They must be mentally-fit and capable of independent daily living activities as they must have the ability to learn and practice the exercise. There is no limitation of age. All participants fulfill the selection criteria and give the consent to the pilot program. The exclusion criteria are men planned or receiving bradytherapy, with urethral or pelvic surgery, suffering from any neurological or cognitive impairment. 32

40 3.2 Transferability of the Findings Transferability refers to whether the selected research findings can fit into the local clinical practice. It is explored as below Setting The target setting of innovation and reviewed studies are done in hospital. In the reviewed studies, the training program was supervised by nurses or physiotherapists. Similarly, the proposed program will be implemented by nurses working in the urology and day wards. Two Advanced Practice Nurses (APN) urology nurses, who are qualified from urology training, will be responsible for implementation of the proposed program before and after operation Characteristics of patients Characteristics of the target audience match greatly with the participants in all reviewed studies in which they were men, aged between 45 and 79, who were undergoing TURP. Most of them were elderly because of the etiology of the disease. The participants in the review studies were predominantly Caucasians but two reviewed studies were conducted in Chinese population (Chang et al., 33

41 1998; Hou et al., 2013). Since the studies in Chinese population also obtained significant positive outcomes, cultural difference may seemingly not a huge concern Philosophy of care The innovation and the review studies are congruent in philosophy of care. They aim to help patients to reduce urinary incontinence or regain urinary continence, and increase their quality of life ultimately. Similarly, the mission of the target setting is to excel in the provision of holistic patient-centered quality care to help people stay healthy (Hospital Authority, 2013a) Sufficiency of clients benefit from the innovation According to the retrospective clinical observation from September 2012 to August 2013, there were 11 of 15 patients underwent elective TURP with the PAS per month. There will be 66 patients benefited in the 6 month - pilot training program Time schedule for implementation and evaluation During the implementation of the program, nurses in urology and day wards 34

42 are the main conductors of PFMT for men undergoing TURP. Urology nurses in day ward will provide pre-operative PFMT when patient having urine and blood investigations at least two weeks before operation. Then nurses will review patients about one week before operation when they admit to day ward for PAS. After operation, nurses in urology ward will reinforce them to practice PFMT on discharge and arrange urology nurses follow-up. Two interview sessions before operation and one session on discharge have to help patients especially elderly to catch up the PFMT technique and increase their compliance. Then patient will follow up at 4 th and 12 th week after operation, which is similar to the majority of the selected studies. 3.3 Feasibility Feasibility of the innovation is more practical concerns which may involve the organization climate, availability of manpower and resources in clinical setting. Patients have right to terminate the program when it is considered undesirable Interference on current staff functions Incorporation of the proposed program into the services of the TURP 35

43 patients, the time and workload of interviewing and assessment are expected to increase. However, PFMT will decrease the number of telephone enquiry and medical consultation relate to urinary incontinence after TURP. From the above estimation, only 11 target patients will join per month. The risk of conflict among nurses is low as it will not significantly increase their workload to provide an individual 30 minutes training session in their first attendances. Then, nurses only need to remind the steps and importance of practice with the help of refrigerator magnet in the follow-up sessions which may spend about 15 minutes in each follow-up session. Currently, nurses are providing PFMT to patients with radical prostatectomy; it will not greatly interfere on current staff functions Administration and resources support Administration support is important for the success of the innovation. The key is to communicate with urologists and gaining their support for the innovation because its low cost and high benefit with the minimal risk to the patients. Since nurses work in urology and day wards are providing PFMT education 36

44 to patients with radical prostatectomy, urology nurses will conduct two identical one hour-briefing sessions introduce this training and evaluation program. There is no special equipment is required for the program. An information leaflet and a refrigerator magnet will be given to the patient. Measuring tools for outcome evaluation are commonly available. The PFMT will be carried in a consultation room in day ward and an interview room in urology ward. Patients will follow-up in the urology nurse clinic to evaluate their outcomes. All of the facilities are currently available. 3.4 Cost-benefit Ratio of the innovation The cost-benefit ratio of the proposed program must be assessed before the implementation Potential risks and benefits of the innovation The potential risk expose to patients is minimal. PFMT is a safe, first conservation management for patient with urinary incontinence after TURP (Harris, 1997; Bauer et al., 2009). Meanwhile, all patients will enroll in the innovation program after assessment from the doctors and nurses in order to 37

45 minimize the potential risk. Patient will benefit from the innovation as they may reduce the risk of urinary incontinence or regain continence earlier after TURP. Patients hospital stay will shorten and reduce their complications related urinary incontinence. They will achieve better quality of life Disadvantage of maintaining current practice At present, some nurses and doctors advice patients to perform PFMT when they had urinary incontinence after TURP. Patients are suffering from a period of urinary incontinence as PFMT needs to take a period of time to be effective. It greatly worsens their quality of life even after operation. Also, we only provide a brief PFMT by means of verbal and written instruction only. Learning the right technique and practicing at home are two key elements in PFMT. Majority of patients for TURP are elderly, they require more instructions, demonstration and encouragement in learning new things. Otherwise, they will abandon the exercise and suffer from urinary incontinence. They become social isolated and depressed. 38

46 3.4.3 Material costs of implementing the innovation The majority of the budget will be spent on the salary of the nurses. There are four contact times between patients and nurses during the program. In the first contact time will be 30 minutes, the following 3 contacts will spend about 15 minutes each time. Totally nurses will spend about 75 minutes to each patient. The urology nurses will attend patients in first and last visits. According to the Master Pay Scale (Civil Service Bureau, 2013), the mean monthly salary with allowances of a Registered nurse (RN) is HK$36,348 and an APN is HK$57,662. They are working for 190 hours per month. The total cost is calculated as follows: Mean salary of a RN is HK$3.19 per minute (HK$36, = HK$3.19/ minute). Mean salary of an APN is HK$5.06 per minute (HK$57, = HK$5.06/ minute). Cost for nursing manpower for one patient is HK$ (HK$3.19 x 30 minutes + HK$5.06 x 45 minutes = HK$323.40). 39

47 Total cost for 6 months is HK$21, (HK$ x 11 patients x 6 months = HK$21,344.40). Other than that, the material costs are low because no additional equipment is required to be purchased. The printing costs of information leaflets, consent forms, questionnaires and assessment forms of the proposed program are low as the printing service is available in the hospital. One hundred of refrigerator magnets will be prepared due to the minimum order in the market; they only cost about HK$300. It is estimated that for a short-term 6 months implementation of the proposed program will cost about HK$21, Material costs of not implementing the innovation If the innovation is not implemented, patients will suffer from urinary incontinence and seek medical service. An average health care service of a patient is one day hospital stay and three times of out-patient follow-up. The estimated cost of one day acute care hospital stay is HK$4,680 and one attendance at a specialist clinic is HK$1,110 (Hospital Authority, 2013b). The minimum cost for 6 months will be: [HK$4,680 + (HK$1,110 x 3 times)] x 11 patients x 6 months = HK$528,660. Meanwhile, medication for urinary 40

48 incontinence and the loss of hospital reputation were uncountable cost Potential non-material costs and benefits of implementing the innovation The potential non-material costs will be increased nurses workload and stress in learning and adapting the proposed program. It is an extended service from patients with radical prostatectomy to TURP. If the innovation comes with a good communication plan with adequate training and information provided to nurses before implementation can greatly reduce their stress. Meanwhile, it gains better nurse-patient trusting relationship with appreciation from patients due to better commitment and quality of care. For hospital, it may reduce the rate of telephone enquiry, clinical follow-up and workload of health care professionals. For nurse professional, it may help to increase nurse autonomy, morale and job satisfaction as it is a nurse-led service Cost-benefit ratio The cost-benefit ratio is HK$21, / HK$528,660 = 0.04, and the uncountable costs are not included. As the cost-benefit ratio is less than 1, this 41

49 innovation is worth to implement. In conclusion, the innovation can be implemented because of its transferability, feasibility and cost-effectiveness. 3.5 Evidence-Based Practice Guideline After affirming the potential of implementing this innovation, an evidence-based guideline is developed based on the selected studies in the previous section Title of the guideline The title is An evidence-based pelvic floor muscle training program to reduce urinary incontinence for patients undergoing transurethral resection of prostate Aim and objectives of the guideline The aim of the guideline is to provide an evidence-based pelvic floor muscle training program to nurses to reduce urinary incontinence for patients undergoing TURP. 42

50 The objectives are: (1) To formulate clinical practice instructions for the patient to regain urinary continence after TURP based on the best evidence available; (2) To reduce the complications related to post-operative urinary incontinence by practicing PFMT; (3) To standardize the PFMT process of patient undergoing TURP Target group The target participants of the innovation are men who are scheduled for elective TURP within at least one week before operation and have PAS in day ward to ensure they have sufficient time for exercise education and practicing at home before operation. They must be mentally-fit and capable of independent daily living activities. The exclusion criteria are men planned or receiving bradytherapy, with urethral or pelvic surgery, suffering from any neurological or cognitive impairment Recommendations The SIGN (2013a) grading system (Appendix 2) will be used to grade the 43

51 recommendation as follow: Recommendations are divided into four parts: (1) Assessment and outcome measurements (2) Pelvic floor muscle training instruction (3) Patient education tools (4) Frequency of follow-up sessions (1) Assessment and outcome measurements Recommendation 1.1: Baseline assessment on urinary incontinence and urinary symptoms should be performed before TURP. (Grade A) Patients undergoing TURP may worsen their urinary symptoms and become urinary incontinence. All the reviewed studies performed baseline assessment to measure the progress of the urinary symptoms and degree of urinary incontinence, four studies showed improved urinary or incontinence status (Chang et al., 1998 (2++); Glazener et al., 2011a (1++); Hou et al., 2013 (1-); Porru et al., 2001 (1+)). 44

52 Recommendation 1.2: Baseline assessment on the strength of pelvic floor muscle should be performed before TURP. (Grade A) Four of the six studies measured the pelvic floor muscle strength by Modified Oxford scale to monitor progress of treatment. Three studies showed improved muscle strength after 4 weeks PFMT (Chang et al., 1998 (2++); Porru et al., 2001 (1+); Tibaek et al., 2007 (1+)). Recommendation 1.3: General health questionnaires which consist of physical, psycho-social and emotional dimensions are suggested for assessment the impact of quality of life related to urinary incontinence. (Grade A) General health questionnaires which consist of physical, psycho-social and emotional dimensions were more sensitive in measuring the impact of quality of life related to urinary incontinence. In Chang et al. (1998) (2++), the total, psycho and social patient satisfaction scores were improved after PFMT. In Hou et al. (2013) (1-), both the physical and mental dimensions in the Short Form Health Survey scale (SF-36) showed improvement after PFMT. In Porru et al. (2001) (1+), the ICS male questionnaire showed improvement after PFMT. Then, 45

53 a commonly used, well-validated with a Chinese version of general health questionnaire is recommended for local practice. (2) Pelvic floor muscle training instruction Recommendation 2.1: Conduct a first teaching session on PFMT by trained health care professional individually. (Grade A) First teaching session on PFMT should be conducted by trained health care professionals individually to ensure patient understand and perform it correctly, clarify any worries to increase their compliance rate (Chang et al., 1998 (2++); Glazener, et al., 2011a (1++); Hou et al., 2013 (1-); Porru et al., 2001 (1+); Tibaek et al., 2007 (1+)). Recommendation 2.2: The strength of pelvic floor muscle contraction should be assessed and taught by digital anal examination with verbal feedback. (Grade A) Digital anal examination with verbal feedback is the key step in learning the correct PFMT. It helps patients control the pelvic floor muscles while keeping the abdominal muscle relaxed with positive feedback from nurses (Chang et al., 46

54 1998 (2++); Glazener et al., 2011a (1++); Hou et al., 2013; Porru et al., 2001; Tibaek et al., 2007). Recommendation 2.3: Patients should be educated for PFMT as soon as before TURP. (Grade A) Patients showed regain urinary continence earlier and increase voiding interval when practicing PFMT before TURP than those of practicing after operation. In Porru et al. (2001) (1+) pre-operative PFMT study, patients showed the earliest improvement of urinary incontinence in voiding diaries after first week of operation. In post-operative PFMT studies, patients got improvement in urinary symptoms after 3 weeks and 4 weeks of operation in Chang et al. (1998) (2++) and Hou et al. (2013) (1-) studies respectively; patients regained urinary continence at 3 months after PFMT in Glazener et al., (2011a) (1++) study. Recommendation 2.4: Patients should practice PFMT in three positions with 1-6 times per days and the knack at home. (Grade A) After reviewing of selected studies, there shared several common contents 47

55 irrespective of no standardized duration and frequent of contractions in PFMT regime. They consisted of practicing slow contractions in lying, sitting and standing positions for 1-6 times per day, 6-10 series of 3-15 slow contractions, duration of each contraction was set up to a maximum of 10 seconds according to patients muscle strength (Chang et al., 1998 (2++); Glazener et al., 2011a (1++); Hou et al., 2013 (1-); Ip, 2004 (1-); Porru et al., 2001 (1+); Tibaek et al., 2007 (1+)). Two studies included knack practice in PFMT to reduce the risk of urinary incontinence in daily life (Glazener, et al., 2013 (1++); Tibaek et al., 2007 (1+)). Knack, tighten the pelvic floor muscle strongly before and during any event which might cause leaking such as coughing and rising from sitting. (3) Patient education tools Recommendation 3.1: Verbal and written instructions of PFMT should be given to patients for home practice. (Grade A) All the reviewed studies provided verbal and written instruction to patients for home practice. It is helpful to remind the technique of PFMT and increase 48

56 their compliance rate for the elderly patients (Chang et al., 1998 (2++); Glazener et al., 2011a (1++); Hou et al., 2013 (1-); Ip, 2004 (1-); Porru et al., 2001 (1+); Tibaek et al., 2007(1+)). Recommendation 3.2: Visual reminder acts as a reminder to practice PFMT at home. (Grade C) A visual reminder such as a refrigerator magnet which contains information on how to perform the PFMT was given to patients to increase their compliance rate. In Ip (2004) (1-), patients demonstrated higher compliance rate of PFMT at 2 weeks after operation in magnet group but they are not demonstrated at 3 months after operation. However, patients appreciated it was a good reminder. Therefore, this visual reminder pairs with early pre-operative PFMT will exhibit greater effect. (4) Frequency of follow-up sessions Recommendation 4.1: After initial PFMT pre-operative teaching session, a reminder session before discharge and a follow-up at 4 th week after operation are suggested to monitor patients progress. (Grade A). 49

57 In the reviewed studies, re-education program of PFMT was important after operation to clarify any misconceptions and reinforce their compliance. All reviewed studies except Glazener et al. (2011a) conducted post-operative PFMT before discharge (Chang et al., 1998 (2++); Hou et al., 2013 (1-); Ip, 2004 (1-); Porru et al., 2001 (1+); Tibaek et al., 2007(1+)). The most frequent duration of follow-up sessions were at 2 nd, 4 th and 12 th weeks after operation in the reviewed studies. However, the 4 th week session got the most significant improvement of urinary incontinence, urinary symptoms, pelvic floor muscle strength and quality of life (Chang et al., 1998 (2++); Hou et al., 2013 (1-); Porru et al., 2001 (1+); Tibaek et al., 2007(1+)). After that, the frequency of follow-up sessions depends on the availability of manpower and budget. Summary of the above recommendations was shown in Appendix 9. 50

58 Chapter 4 Implementation Plan After development of an evidence-based guideline in the previous chapter, nurses of a local acute hospital are advised to conduct pelvic floor muscle training with patients undergoing transurethral resection of prostate. A clear and detailed implementation plan, which includes a communication plan, a pilot study plan and an evaluation plan, is described. 4.1 Communication Plan In the communication plan, potential stakeholders will be identified and related communication process will be discussed Identifying the stakeholders Stakeholders should be identified before formulating the communication plan. There are five major groups of stakeholders anticipated in this innovation. 51

59 Firstly, stakeholders at the administrative level are most powerful and influential. The Consultant of the Urology team, the Department Operational Manager (DOM) and Ward Managers (WMs) of day ward and urology ward are responsible for monitoring and managing the quality of care in the setting. They decide whether the proposed program will be funded or approved. Getting their supports help to implement and run the proposed program efficiently as they can act as a liaison among all staffs and have ability to coordinate and assign work to staff in the innovation. Secondly, urology nurses in day ward are responsible for providing pre-operative assessment and investigations to patients with elective urology operations. They are the main program conductors. They are directly affect and are responsible for the implementation of the proposed program. Gaining of their support is vital for the innovation. They are responsible for promotion of quality of life by gaining urinary continence and reducing post-operative complications. Thirdly, all urology doctors will be involved in the program, and the Consultant of the Urology team will be invited to be an adviser on the program. Doctors are collaborative partners in the innovation as they are responsible to 52

60 introduce the program to potential patients, answer their questions and arrange patients admitted to pilot day ward one week before TURP for pre-operative assessment. After TURP, doctors arrange combine follow-up appointments with urology nurses to those patients. Fourthly, nurses in day ward and urology ward are conductors of the innovation. The workload and stress may be increased because they need to acquire knowledge and skills and integrate the innovation into their nursing care. The difficulty is not large as the education of PFMT is extended from radical prostatectomy patients to TURP patients. To reduce any resistance, details of the program will be disseminated and time allowed for review will be available to them; and education sessions with demonstration will be given to them. Lastly, men who will be referred to the proposed program by doctors or nurses are stakeholders of the program. They are being informed of their right to choose whether to join the proposed program The communication process The process of the communication includes communication sequences of 53

61 the stakeholders and how to initiate, guide and sustain the change. The program coordinator is a key person in communicating with different stakeholders and responsible for providing a clear vision of the program and its aims, needs and significance, the best evidence from a wide range critical appraisal review, and its transferability, feasibility and cost-benefit analysis. The urology nurse is the first person to be contacted informally as he will be the major program conductor. As mentioned before, gaining his support is the key success of the program. A full written proposal and guideline emphasized the importance of the development of an evidence-based PFMT program to reduce urinary incontinence for patients undergoing TURP will be given to him. Recommendations may be obtained from him who is useful to finalize the pilot study proposal. Then, the proposed program will be presented to the administrators along with him. A formal meeting will be arranged with the WMs of the day ward and urology ward, and the DOM. A clear and precise power point presentation with a 54

62 written proposal will be prepared to communicate. A meeting with the Consultant of the Urology team will be arranged after gaining their operational approval. As they are the budget holders, the cost-benefit ratio of the proposed program will be illustrated in the meetings. After gaining their support, the information of the proposed program will be disseminated to the urology doctors, WMs, urology nurses and frontline nurses who will be involved. A formal departmental meeting will be arranged to disseminate the information of the proposed program to the nurses and doctors, which is held every three months. Also, the information of the proposed program will be disseminated via multiple channels which are include internal s and ward briefing sessions as well Initiating, guiding and sustaining the change To initiate the proposed change, a working group will be formed to facilitate communication between nurses in different working areas and provide feedback to improve the nursing practice. It includes four members, program coordinator, urology nurse and one nurse representative from day ward and urology ward. 55

63 The aims of the innovation are clearly stated that patients will not develop urinary incontinence or will regain urinary continence after PFMT. An evidenced-based guideline was developed with the wide ranged critical review showing that PFMT is an effective conservative treatment for TURP patients. A pocket guide with aims, guideline and patient journey of the innovation will be designed and distributed for quick references. To implement the innovation, an action plan with a clear time frame will be established. In the program, obtaining approval from the above stakeholders will last for three months. Then, a three-month pilot study will be implemented to test the guideline and evaluate the proposed changes. Before the pilot study, two identical one hour briefing sessions introduce PFMT and the evaluation of the muscle strength; and the program details will be given to all involved nurses. It is provided by urology nurses and organized by the program coordinator. Ward conferences will be held monthly to provide educational and feedback channels. Besides, the logistic arrangements for the design and adequate supply of the pocket guide, information leaflet, posters and 56

64 refrigerator magnets are the responsibility of the working group. In order to ensure the sustainability of the proposed program, the working group will monitor and evaluate the effectiveness of the proposed change continuously by observing patient outcomes such as incident rate, severity of urinary incontinence, quality of life and satisfaction. Also, observing nurse s outcomes in self-perceived skill, confidence level and satisfaction with the new guideline by means of questionnaires. If the pilot program showed significant benefit to those patients, the program will be promoted to all patients receiving TURP in the hospital. 4.2 Pilot Study Plan A 6-month pilot study will perform before the full-scale implementation of the program. Before the pilot study, all nurses in the pilot wards will be completely trained by lecture and ward conferences. However, only nurses with more than five years of experience will be recruited in this pilot study. There are 26 nurses in the pilot wards, of whom 13 nurses have more than five years of experience. To ensure the reliability, all nurses must pass the practical assessment on PFMT by urology nurses. Also, they must be evaluated to ensure 57

65 understanding of the measurement and evaluation tools. It will be carried in a urology ward and a day ward respective to the workflow. If the patients admitted for elective TURP with at least one week pre-admission assessment in day ward and meet the required eligibility criteria of cognitive intact and able to understand the instructions, they will become target participants. If patients were planned or receiving bradytherapy, with urethral or pelvic surgery, suffering from neurological disease or cognitive impairment will be excluded in this study. Also, the measuring and evaluation tools will be tested to evaluate the outcome effectively and accurately. They include voiding diary, the International Consultation on Incontinence Modular Questionnaire - Urinary Incontinence Short Form in English (ICIQ-UI SF) (Appendix 10) and the validated Chinese version (Appendix 11); and pelvic floor muscle strength assessment by using Modified Oxford Scale. Nurses will record patients incontinence status and pelvic floor muscle strength before operation and patient progress in patient progress form after operation. Patients will be followed up at 4 th and 12 th week after operation. Then, the compliance of nurses and patients will be monitored by 58

66 patient progress form. For nurses, they can bring out their concerns or difficulties through monthly ward conferences and evaluation questionnaire as well. A questionnaire concerning the self-perceived level of competency in skills and knowledge in implementing the program and the satisfactory level of the program is designed (Appendix 12). After the pilot study, the proposed innovation will be reviewed according to the collected data about the patients outcomes and nurses concern, logistic supply and usage of resources. A formal meeting will be held to explain any modification made to the program and announce full-scale implementation in the pilot urology and day wards. 4.3 Evaluation Plan The evaluation plan is to examine the effectiveness of the program and to evaluate the clinical benefits of the proposed program. 59

67 4.3.1 Nature of clients to be involved The inclusion and exclusion criteria for patients to be evaluated are the same as the pilot study plan and based on the identified evaluation studies. All the recruited patients will be evaluated. Also, all nurses working in the urology and day wards; and two urology nurses are the conductors of the program. They are subject to be evaluated Outcomes measurement The patient, healthcare provider and program outcomes will be measured in order to examine whether the program will achieve its objectives and clinical benefits. Patient outcomes The primary outcome of this innovation program is the continence rate; other two secondary outcomes are the severity of urinary incontinence and the impact on quality of life of urinary incontinence. Based on the reviewed studies, the continence rate was mostly measured by self-reporting 48 hours voiding diary (Chang et al., 1998; Glazener et al., 2011; 60

68 Hou et al., 2013; Porru et al., 2001). Patients need to return their voiding diaries on the day of pre-admission assessment in day ward and follow-ups in clinic at 4 th and 12 th week after discharge (Chang et al., 1998; Hou et al., 2013; Porru et al., 2001). Patients will be defined as continence if no leaking of urine was noted. In addition, the severity and frequency of the incontinence are measured in voiding diary and the ICIQ-UI SF. Simultaneously, ICIQ-UI SF measures the impact of urinary incontinence to quality of life (Glazener et al., 2011). ICIQ-UI SF has been fully validated and published; it gets a grade A highly recommended self-reporting tool in evaluating the severity of urinary incontinence and the impact of symptoms of urinary incontinence on quality of life and outcome of treatment (Abrams et al., 2006). ICIQ-UI SF mainly consists of 4 brief questions. One of the questions will ask patient about the impact of everyday life, score (1-10). The lowest score reflects the least impact on quality of life related to urinary incontinence. Finally, an ICIQ score (0-21) yield from questions. The highest score reflects the highest frequency and the largest amount of urinary incontinence with the greatest 61

69 impact on quality of life. Questionnaire is self-reported by patient or with the help of a nurse to ask him the questions. Measurements are taken on the day of pre-admission assessment and at 4 th and 12 th weeks post-operatively (Chang et al., 1998; Glazener et al., 2011; Hou et al., 2013; Porru et al., 2001). Healthcare provider outcomes The healthcare provider outcomes of self-perceived level of competency in skills and knowledge in implementing the program, and satisfactory level of the program are measured by a self-designed questionnaire (Appendix 12). Questionnaires will be collected after the training sessions and the implementation of the pilot program. Personal identification information is not included in the questionnaire to ensure honest response. Program outcomes To measure program effectiveness, the utilization of the program, assigned manpower and costs evaluation are the basic measures. The program utilization rate will be calculated by the number of patients who are willing to join the 62

70 program over all eligible patients. Also, patients attendance and attrition rates will be used for measuring utilization rate. The patient progress form, from pre-admission assessment to post-operative follow up, will be used to evaluate the utilization of the program. Nurses need to enter the information about patients attendance, voiding diary, pelvic muscle strength assessment and the practice of pelvic floor muscle exercise at home. Also, nurses need to record the education and advice given in every session of interview and on day of discharge. The actual costs of the program will be calculated. The material cost of the program is low; it is mainly from the design and photocopying of the information sheets, posters, patient progress forms and the refrigerator magnets. Manpower is the major expenses in the program. It will be measured from the patient progress form which will be collected after the implementation of the pilot program. All the expenditure will be carefully recorded and controlled as a base of the full implementation of the program Number of patients to be involved The number of patients to be involved depends on the primary outcome of 63

71 the program and the data analysis method. This study is a pre-test and post-test design, two-tailed paired t-tests will be used for the calculation of the sample size. The program is to determine the continence rate is changed since the implementation of the innovation. From the reviewed study (Porru et al., 2001), the continence rate in 3 weeks (80% vs 12.8%), with the power set at 90% and the level of significance at 0.01, the number of patients was 22. The dropout rate was 5.17% in 4 weeks, that is, the sample size will be 23.2 patients. In the three reviewed studies with 12 weeks program, the dropout rates ranged from 0 to 15.52% (Hou et al., 2013; Ip, 2004; Tibaek et al., 2007). From the previous data, there were about 11 patients underwent elective TURP with the pre-admission system per month; of which, 26 patients will be required for 15.52% dropout rate in a 12 weeks program. It is estimated that recruitment of 52 patients in the 12 weeks program would take about 6 months Data analysis The primary outcome continence rate is the proportion of patients whose 64

72 urine loss is zero as recorded in 48 hours voiding diary. The increased percentage of patient getting continence indicates the degree of effectiveness of this program. The severity of urinary incontinence is measured in one of the question in ICIQ-UI SF. It is categorized into four degrees and scores (0-6), none (0), a small amount (2), a moderate amount (4) and a large amount (6). The program is considered effective if the mean score decreased. The degree of impact of urinary incontinence affects patients quality of life was indicated in one of the question in ICIQ-UI SF. It is a 10 point scale; the lowest point means not a trouble, the highest point mean a great trouble in daily life. Finally, an ICIQ (0-21) score is the sum score of the ICIQ-UI SF. The decrease of these mean scores indicates the success of the program. Descriptive statistics will be used to summarize patients demographic data. In addition, pre- and post-interventions will be analyzed by paired t-tests. They will apply to detect the mean change in frequency and amount of urine loss, degree of impact in daily quality of life, ICIQ score, pelvic floor muscle strength, 65

73 patients average time for exercise per week in cycle, patients and nurses satisfaction level, nurses self-perceived skill and confidence level Criteria for considering the program effective The program will be considered as effective if the outcomes are achieved. Since the primary outcome of the program is urine continence, if the mean of continence rate is increased after 12 weeks of PFMT program, the program will be considered effective. The program will also be considered effective if it shows a statistically significant positive effect on the patients mean change of the amount of urine loss, impact of the quality of life score and the ICIQ score. At least 70% of the patient progress form is fully completed. In addition, the program will also be considered as effective if 70% or more of patients and nurses choose agree or above in the questionnaire for their satisfaction level; and achieved 80% of nurses choose agree or above in the self-perceived skill and confidence level. 66

74 For the utilization of the program, the program will be considered as effective if 70% or more of the eligible patients show their willingness to join the program, patients attendance rate is higher than or equal to 70%, and the patients attrition rate is less than or equal to 15%. For the costs of the program, if the total expenditure of the program is within the budget limit, the program will be considered as effective. 67

75 Chapter 5 Conclusion In conclusion, this thesis proposes an evidence-based pelvic floor muscle training program to reduce urinary incontinence for patients undergoing transurethral resection of prostate in a local acute hospital. It aims to reduce the complications related to post-operative urinary incontinence by practicing PFMT and to improve their quality of life. The development of the guideline is brought through the systematic literature searching and quality assessment of the reviewed articles. Articles include five RCTs and one controlled trial. The proposed PFMT program is affirmed its implementation potential. It is analysed and resulted with high local transferability and feasibility, and low cost-benefit ratio. Also, the potential risk exposes to patients is minimal. It is worth to implement it in local clinical setting as discussed. 68

76 Based on the reviewed studies and local clinical setting, the evidence-based PFMT guideline is developed based on four parts. They are assessment and outcome measurements, PFMT instructions, patient education tools and frequency of follow-up sessions. After that, an implementation plan which includes a communication plan, a pilot study plan and an evaluation plan are designed to guide its implementation in the local clinical setting. Finally, it hopes that the developed evidence-based PFMT program can provide healthcare providers, especially nurses, with an evidence-based approach to promote PFMT to reduce the duration or amount of urinary incontinence for patients after TURP and improve their quality of life. In turns, it reduce the social and health burden of the society. 69

77 List of Appendices Appendix 1: Search Strategies and Result A search of literature was conducted on 18 August Item No. Database Keyword CINAHL Plus ( August 2013) PubMed ( August 2013) Science Direct ( August 2013) British Nursing Index ( August 2013) #1 Prostate #2 Urinary incontinence #3 Pelvic floor #4 #1 and #2 and # #5 Transurethral resection of prostate #6 #4 and # #7 Benign prostate hyperplasia #8 Pelvic floor muscle 4459 exercise #9 #6 and #7 288 #10 #8 and #9 112 Selected articles after screening title and abstract Selected articles after screening full paper with inclusion and exclusion criteria Total number of trials selected after singling 6 randomized controlled trials out duplicated studies 70

78 Appendix 2: Table of the Scottish Intercollegiate Guidelines Network (SIGN) Grading System Levels of Evidence Level Description 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias 2++ High quality systematic reviews of case control or cohort or studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g. case reports, case series 4 Expert opinion Grades of Recommendations A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B C A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Good practice points Recommended best practice based on the clinical experience of the guideline development group 71

79 Appendix 3: Tables of Evidence Bibliographic Study type Number of Patient Intervention Comparison Length of Outcome measures Effect size citation Evidence patients characteristics follow up Intervention vs Comparison level Chang et al. Controlled N = 50 Men with BPH n = 25 n = 25 (a) Before (1) Men with (1d) 1 vs 9 (p < 0.05) (1998) trial underwent TURP. - Perform PFMT - No PFMT operation incontinence (1e) 1 vs 8 (p < 0.05) 2++ Dropout: 0 every day after - Mean age = (b)1 week (2)Men with (2e) 3 vs 10 (p < 0.05) Inclusion criteria: removal of 64 (45-79) (c) 2 week terminal (3a) 23 vs 22 The first 25 Age < 80 years, urinary years (d) 3 week dribbling (3b) 11 vs 10 men served frequency, terminal catheter in 1-2 (e) 4 week (3)AUA symptom (4e) Grade 1: -8% (p < 0.05) as a control dribbling, urinary days after after score Grade 2: -3% (p < 0.05) group, the incontinence, operation operation (4)Pelvic floor Grade 3: 0% (p < 0.05) next 25 men ambulatory and - Attend clinic muscle strength Grade 4: 5% (p < 0.05) were the communicable. weekly for (5) Uroflowmetry (5) No significant difference intervention evaluating parameters (6b) 30.4 (p < 0.01) group Exclusion criteria: PFMT (6)Voiding interval (6c) 43.2 (p < 0.01) pelvic surgery, - PFMT daily at (minutes) (6d) 41.6 (p < 0.01) urethral surgery, home (7)Patient (6e) 43.4 (p < 0.01) neurogenic bladder. - Mean age = 65 satisfaction (7e) (i) (p < 0.01) (51 74) years score: (ii)

80 (i) total score (ii) emotional (iii) psychological & social (iv) physical General comment: - Pelvic floor muscle strength- digital rectal examination, grade (0, none 4, strong). - It is a controlled trial. Method of subject allocation is not randomized. The concealment is not mentioned. The blinding is not possible. - PFMT helped to regain continence, reduce urinary symptoms and improve quality of life after 4 weeks. (iii) (p < 0.01) (iv)

81 Bibliographic citation Study type Evidence level Number of patients Patient characteristics Intervention Comparison Length of follow up Outcome measures Glazener et al. RCT N = 442 Men with n = 220 n = 222 Baseline, 3, (1)Men with (2011a) 1++ persistent Lifestyle advice Standard care to 6, 9 and 12 incontinence Dropout: urinary leaflet and 4 provide lifestyle months after (2)ICI-Q score 45 incontinence at individual advice leaflet randomizatio (3)PFME compliance 6 weeks after PFMT sessions only, no PFMT. n (4)Use of aids TURP in 34 UK with a therapist (5)EQ-5D centers in 3 months Mean age = 67.9 (6)SF-12 mental ± 8.1 years (7)SF-12 physical Exclusion An PFMT (8)QALYs criteria: leaflet was given Other outcomes: Men had been for home urinary frequency, received formal exercise nocturia, urgency, PFMT, after program erectile dysfunction, channel TURP, faecal incontinence, radiotherapy. Mean age = 68.2 constipation ± 7.7 years General comment: The intervention increases the PFMT compliance. It does not result in better short-term or medium-term continence rate or quality of life. Effect size (95% CI), p value (1) 1.06 (0.91 to 1.23), 0.47 (2) (0.78 to 0.71), 0.93 (3) 3.20 (2.37 to 4.32), (4) 0.91(0.56 to1.46), 0.68 (5) (-0.04 to 0.03), 0.79 (6) (-1.71 to 1.63), 0.96 (7) 0.39 (-1.22 to 1.99), 0.64 (8) ( to 0.026) 74

82 One to one teaching of PFMT is unlikely to be effective or cost-effective compared to standard care with provision of lifestyle advice leaflet. There were high rate of men with urinary incontinence in both intervention and control groups (64.9% and 61.6%) after 12 months. It may indicate a substantial unrecognized complicated urinary incontinence after TURP. Information about PFMT was freely available in the study area; there was 21% of the subjects doing PFMT after TURP before randomization. 75

83 Bibliographic citation Study type Evidence level Number of patients Patient characteristics Hou et al. RCT N = 66 Men with BPH (2013) 1- underwent TURP. Excluded: 2 with Inclusion criteria: foley Age: years, catheter on remarkable LUTS, discharge ambulatory and able to Dropout: 3 communicate was lost in verbally. follow-up Exclusion criteria: Discharge with urinary catheter, neurogenic bladder, and dementia. General comment: Detail method of randomization was not mentioned. Intervention Comparison Length of Outcome measures Effect size follow up n = 32 - Perform PFMT every day after removal of urinary catheter 2 days post-operatively - Apply EMG to confirm correct PFMT - Reminded by telephone at least once a week - Mean age = 69.67± 6.09 years n = 29 - No PFMT - Mean age = ± 6.67 years Before operation and 1, 4, 8, 12 weeks after operation (1)Men with incontinence (4 weeks) (2)IPSS (4 weeks) - Voiding score - Storage score (3) Q max (4) VV (5) PVR (6) SF-36 physical (7) SF-36 mental Subject-expectancy effect might cause some biased in this study as a complete educational program was only provided to the interventional group. (1) 3vs 2 = 0 vs 0 (2) (p <0.001) (p = 0.511) (p < 0.001) (3) 4 (p = 0.026) (4) (p = 0.097) (5) (p = 0618) (6) 5 (p = 0.029) (7) 7.69 (p = 0.005) 76

84 Bibliographic Study type Number of Patient Intervention Comparison Length of Outcome measures Effect size citation Evidence patients characteristics follow up level Ip (2004) RCT N = 16 English n = 9 n = 7 Before (1) St. George Magnet vs Paper (%) 1- speaking male (TURP: 6, (TURP: 5, operation Urinary (1a) 55.6 vs 42.9 patients RP: 3) RP: 2) and telephone Incontinence (1b) 33.3 vs 28.6 undergoing Information on Information on survey after Score (2a) 66.7 vs 57.1 either radical bladder habit bladder habit operation at: (2) PFMT compliance (2b) 66.7 vs 85.7 prostatectomy and PFMT on a and PFMT on a (a) 2 weeks (RP) or TURP. refrigerator paper handout (b) 3 months magnet was was given in the Mean age not given in the pre-admission mentioned pre-admission clinic clinic General comment: St. George Urinary Incontinence Score, 5 items with score 0 (never) 4 (always), total score = The sample size is small due to the premature call-off (restructure of pre-admission clinic). No evidence of men with magnet group with higher compliance of PFMT or continence compared to paper group. 77

85 Bibliographic Study type Number of Patient characteristics Intervention Comparison Length of Outcome measures Effect size citation Evidence patients follow up level Porru et al. RCT N = 58 Men with BPH n = 28 n = 27 Before (1) No. of incontinence (1a) 8 (p < 0.01) (2001a) 1+ Dropout: 3 undergoing TURP PFMT teaching Not specified operation patient by voiding (1b) 11 (p < 0.01) pre-operative and and diaries (1c) 8 (p < 0.01) Exclusion criteria: training sessions Mean age = (a) 1 week (2) AUA Symptom Score (1d) Not significant Aged over 80 years at follow-up 67.5 (55-73) (b) 2 week (3) ICS male questionnaire (2d) Not significant old or with urethral or (weeks 1, 2, 3, 4) years (c) 3 week (4) PFM contraction (3d) -1.7 (p < 0.001) pelvic surgery, and written (d) 4 week strength (4d) 1.4 (p < 0.01) neurogenic bladder or instruction for after (5) Voiding interval (5b) 35.5 (p < 0.01) prostatic cancer. home PFMT TURP (6) Uroflowmetry (5d) 8.5 (p < 0.01) parameters (6d) Not significant Mean age = 66 (53-71) years General comment: Significant less continence in the intervention group at 1, 2, 3 weeks, but no different at 4 weeks after operation. PFMT helps men to regain continence earlier after TURP. 78

86 Bibliographic Study type Number of Patient Intervention Comparison Length of follow Outcome measures Effect size citation Evidence patients characteristics up level Tibaek, et al. RCT N = 58 Ambulatory men n = 26 n = 23 Before operation (1) UI (pad test (1b) 8 (p = 0.755) (2007) 1+ Dropout: 9 with Start at No and g/24 hours) (2) 24/26 attended uncomplicated pre-operatively, pre-operative (a) 2 weeks (2) PFMT all training Randomization benign prostate PFMT individual PFMT. (b) 4 weeks compliance sessions by grouping in obstruction who and group lessons, Give PFMT (c) 3 months (3) DAN-PSS-1 (3a) 2.5 (p = blocks of ten in a were planned for and home training knowledge after score 0.927) mathematical TURP. program. and verbal operation (4) PFM - static (3b) 5 (p = 0.452) table instructions 2 endurance (3c) -1 (p = 0.754) Exclusion criteria: Give verbal to 3 days after (5) PFM - dynamic (4b) 86% vs prostate cancer, instructions after TURP. endurance 12.5% previous lower TURP. (6) Voiding improvement urinary tract parameters (p = vs surgery, Mean age:70 Mean age: ) neurological (58-77) years (52-79) years (5b) 16 (p = 0.049) disease. (6) No significant differences General comment: 79

87 DAN-PSS-1: Danish Prostatic Symptom Scale, ranges from The exact duration of practicing pre-operative PFMT was not mentioned, it might affect the study result directly. 80

88 Appendix 4: Methodology Checklists S I G N Methodology Checklist 2: Controlled Trials Study identification (Include author, title, year of publication, journal title, pages) Chang, P. L., Tsai, L. H., Huang, S. T., Wang, T. M., Hsieh, M. L., & Tsui, K. H. (1998). The early effect of the pelvic floor muscle exercise after transurethral prostatectomy. The Journal of Urology, 160, SECTION 1: INTERNAL VALIDITY In a well conducted RCT study 1.1 The study addresses an appropriate and clearly focused question. 1.2 The assignment of subjects to treatment groups is randomised. 1.3 An adequate concealment method is used 1.4 Subjects and investigators are kept blind about treatment allocation. 1.5 The treatment and control groups are similar at the start of the trial. 1.6 The only difference between groups is the treatment under investigation. 1.7 All relevant outcomes are measured in a standard, valid and reliable way. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the Does this study do it? Yes. No. Allocated the groups by preceding and subsequent subjects without randomization. No. Allocation concealment is not mentioned. No. Subjects and therapists cannot be blinded except the data entry clerical staff. Yes Yes Yes 0/50 x100% = 0% 81

89 study dropped out before the study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Where the study is carried out at more than one site, results are comparable for all sites. Does not apply. All participants were accounted for and none was lost to follow-up at 4 weeks period. Does not apply. This study is carried out in one site. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Acceptable (+) The overall effect is due to the study intervention even the method of subjects allocation is not randomised. Yes. High participation rate (100%, n = 50). It can be applied to the target patient group. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above. PFMT is useful in reducing urinary incontinence and terminal dribbling in 4 weeks after TURP, and provides better psychological and social quality of life. This study should be a controlled trial 82

90 S I G N Methodology Checklist 2: Controlled Trials Study identification (Include author, title, year of publication, journal title, pages) Glazener, C., Boachie, C., Buckley, B., Cochran, C., Dorey, G., Grant, A., Hagen, S., Kilonzo, M., McDonald, A., McPherson, G., Moore, K., N' Dow, J., Ramsay, C., & Vale, L. (2011a). Conservative treatment for urinary incontinence in men after prostate surgery (MAPS): two parallel randomized controlled trials. Health Technology Assessment, 15(24), SECTION 1: INTERNAL VALIDITY In a well conducted RCT study 1.1 The study addresses an appropriate and clearly focused question. 1.2 The assignment of subjects to treatment groups is randomised. Does this study do it? Yes Yes. Remote computer allocation. 1.3 An adequate concealment method is used 1.4 Subjects and investigators are kept blind about treatment allocation. 1.5 The treatment and control groups are similar at the start of the trial. 1.6 The only difference between groups is the treatment under investigation. 1.7 All relevant outcomes are measured in a standard, valid and reliable way. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the Yes No. Subjects and therapists cannot be blinded except the data entry clerical staff. Yes Yes Yes 45/442 x 100% = 10.18% 83

91 study was completed? 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Where the study is carried out at more than one site, results are comparable for all sites. Yes Yes, there is no marked difference in the 34 UK centers data reported SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? High quality (++) The overall effect is due to the study intervention as it demonstrates good randomization, allocation concealment and possible blinding techniques. Yes. High participation rate (86%, 442 of 512) and the large number of UK centers contributes participants, findings can be generalized. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above. The intervention increases the PFMT compliance. It does not result in better short-term or medium-term continence rate or quality of life. One to one teaching of PFMT is unlikely to be effective or cost-effective compared to standard care with provision of lifestyle advice leaflet. There are high rate of men with urinary incontinence in both intervention and control groups (64.9% and 61.6%) after 12 months. It may indicate a substantial unrecognized complicated UI after TURP. 21% of the subjects doing PFMT after TURP before randomization. Information about PFMT is freely available; it is not possible to identify a control group that was unaware of PFM exercise. 84

92 S I G N Methodology Checklist 2: Controlled Trials Study identification (Include author, title, year of publication, journal title, pages) Hou, C. P., Chen, T. Y., Chang, C. C., Lin, Y. H., Chang, P. L., Chen, C. L., Hsu, Y. C., & Tsui, K. H. (2013). Use of the SF-36 quality of life scale to assess the effect of pelvic floor muscle exercise on aging males who received transurethral prostate surgery. Clinical Intervention in Ageing, 8, SECTION 1: INTERNAL VALIDITY In a well conducted RCT study 1.1 The study addresses an appropriate and clearly focused question. 1.2 The assignment of subjects to treatment groups is randomised. 1.3 An adequate concealment method is used. 1.4 Subjects and investigators are kept blind about treatment allocation. 1.5 The treatment and control groups are similar at the start of the trial. 1.6 The only difference between groups is the treatment under investigation. 1.7 All relevant outcomes are measured in a standard, valid and reliable way. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Does this study do it? Yes Can t say. Randomization is mentioned, but method is not specified. No. Concealment method is not mentioned. Cant say. The presence of blinding is not mentioned. Blinding of special technicians teaching PFMT cannot be blind. Yes Yes Yes 5/66 x100% =7.58% 85

93 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Where the study is carried out at more than one site, results are comparable for all sites. Yes Does not apply. This study is carried out in one site. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Acceptable (+) The overall effect is due to the study intervention. The methodology was not mentioned clearly in randomization, allocation concealment and blinding. Yes. The mean age and urinary symptoms of subjects are typical presentations of the TURP patients. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above. Patients who performed PFMT for 12 weeks with closed monitoring by health care professionals after TURP showed quicker improvement of urinary symptoms especially in storage symptoms; and their quality of life than those without PFMT. 86

94 S I G N Methodology Checklist 2: Controlled Trials Study identification (Include author, title, year of publication, journal title, pages) Ip, V. (2004). Evaluation of a patient education tool to reduce the incidence of incontinence post-prostate surgery. Urologic Nursing, 24(5), SECTION 1: INTERNAL VALIDITY In a well conducted RCT study 1.1 The study addresses an appropriate and clearly focused question. 1.2 The assignment of subjects to treatment groups is randomised. 1.3 An adequate concealment method is used. 1.4 Subjects and investigators are kept blind about treatment allocation. 1.5 The treatment and control groups are similar at the start of the trial. 1.6 The only difference between groups is the treatment under investigation. 1.7 All relevant outcomes are measured in a standard, valid and reliable way. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Does this study do it? Yes Can t say. Only convenience randomized sampling was mentioned. Allocation method was not mentioned. No. Concealment method is not mentioned. No. Blinding is not possible for patients and nurses Can t say. Only the compliance of PFMT and incontinence score were mentioned in baseline data. Yes Can t say. Only the numbers of patient performing PFMT and incontinence score were presented. No statistical measurement was mentioned. 0/16 x100% = 0% 87

95 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Where the study is carried out at more than one site, results are comparable for all sites. Not applicable. All participants were accounted for and none was lost to follow-up at 3 months period. Not applicable. This study is carried out in one hospital center. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Low quality (0) The overall effect of the study was difficult to say as it only mentioned randomized convenience sampling method. The result was presented without any statistical measurement. The major limit of this study was the very small sample size due to be terminated prematurely. No, too small sample size. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above. Inconclusive due to the study was terminated prematurely. Men in magnet group seemed to get better incontinence score than those in paper group. A visual reminder might be helping in adhering the PFMT. 88

96 S I G N Methodology Checklist 2: Controlled Trials Study identification (Include author, title, year of publication, journal title, pages) Porru, D., Campus, G., Caria, A., Madeddu, G., Cucchi, A., Rovereto, B., Scarpa, R. M., Pill, P., & Usal, E. (2001). Impact of early pelvic floor rehabilitation after transurethral resection of the prostate. Neurourology and Urodynamics, 20, SECTION 1: INTERNAL VALIDITY In a well conducted RCT study 1.1 The study addresses an appropriate and clearly focused question. 1.2 The assignment of subjects to treatment groups is randomised. 1.3 An adequate concealment method is used. 1.4 Subjects and investigators are kept blind about treatment allocation. 1.5 The treatment and control groups are similar at the start of the trial. 1.6 The only difference between groups is the treatment under investigation. 1.7 All relevant outcomes are measured in a standard, valid and reliable way. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Does this study do it? Yes Can t say. Only randomization is mentioned, but method not specified. No. The concealment method is not reported Yes. A double blinding study. An urologist performing digital evaluation of pelvic floor muscle contraction was blinded to the study group. Yes Yes Yes 3/58 x100% = 5.17% 89

97 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Where the study is carried out at more than one site, results are comparable for all sites. Yes Does not apply. This study is carried out in one hospital center. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Acceptable (+) The overall effect is due to the study intervention as it includes random assignment in group allocation and blinding of the assessor. However, the method of randomization is not provided. Yes. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above. PFMT starts in pre-operative produces a quicker improvement of incontinence state, urinary symptoms and of QOL in patients after TURP. 90

98 S I G N Methodology Checklist 2: Controlled Trials Study identification (Include author, title, year of publication, journal title, pages) Tibaek, S., Klarskov, P., Hansen, B. L., Thomsen, H., Andresen, H., Jensen, C. S., & Olsen, M. N. (2007). Scandinavian Journal of Urology and Nephrology, 41, SECTION 1: INTERNAL VALIDITY In a well conducted RCT study 1.1 The study addresses an appropriate and clearly focused question. 1.2 The assignment of subjects to treatment groups is randomised. 1.3 An adequate concealment method is used. 1.4 Subjects and investigators are kept blind about treatment allocation. 1.5 The treatment and control groups are similar at the start of the trial. 1.6 The only difference between groups is the treatment under investigation. 1.7 All relevant outcomes are measured in a standard, valid and reliable way. 1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed? Does this study do it? Yes Yes. Mathematical table, grouped in blocks of ten. Yes. Sealed envelopes by independent third party Yes. Single blinding. Independent physiotherapist took pelvic floor assessment before and 4 weeks after operation. Not possible to blind the patients and intervention physiotherapist. Yes Yes Yes 9/58 x100% = 15.52% 91

99 1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis) Where the study is carried out at more than one site, results are comparable for all sites. Yes Does not apply. This study is carried out in one site. SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? 2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention? 2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? High quality (++) The overall effect is due to the study intervention as it demonstrates good randomization, allocation concealment and blinding techniques. A good reliability in pelvic floor muscle assessment and PFMT teaching by one physiotherapist. Yes. 2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above. Pre-operative PFMT produced a significant improvement in pelvic floor muscle endurance after TURP. No differences between the groups in lower urinary tract parameters. The exact duration of providing pre-operative PFMT was not mentioned while the control group received verbal instruction about PFMT after 2-3 days of operation. The length of practicing PFMT before operation is a critical factor for significant result in this study. 92

100 Appendix 5: Summary of Levels of Evidence Bibliographic citation Study Type Level of Evidence Chang, et al. (1998) Controlled trial 2 ++ Glazener et al. (2011a) RCT 1 ++ Hou et al. (2013) RCT 1- Ip (2004) RCT 1- Porru et al. (2001) RCT 1+ Tibaek et al. (2007) RCT 1+ 93

101 Appendix 6: Summary of Quality Assessment of the Selected Studies Controlled Trials Checklist Chang, et al. (1998) Glazener et al. (2011) Hou et al. (2013) Ip (2004) Porru et al. (2001) Tibaek et al. (2007) 1 The study addresses an appropriate and clearly focused question. Yes Yes Yes Yes Yes Yes 2 The assignment of subjects to treatment groups is randomised. No Yes Can t say Can t say Can t say Yes 3 An adequate concealment method is used. No Yes No No No Yes 4 Subjects and investigators are kept blind about treatment allocation. No No Can t say No Yes Yes 5 The treatment and control groups are similar at the start of the trial. Yes Yes Yes Can t say Yes Yes 6 The only difference between groups is the treatment under investigation. Yes Yes Yes Yes Yes Yes 7 All relevant outcomes are measured in a standard, valid and reliable way. Yes Yes Yes Can t say Yes Yes 8 What percentage of the individuals or clusters recruited into each 0% 10.18% 7.58% 0% 5.17% 15.52% treatment arm of the study dropped out before the study was completed? 9 All the subjects are analysed in the groups to which they were randomly Does not Yes Yes Does not Yes Yes allocated (often referred to as intention to treat analysis). apply apply 10 Where the study is carried out at more than one site, results are comparable for all sites. Does not apply Yes Does not apply Does not apply Does not apply Does not apply 11 How well was the study done to minimise bias? Acceptable (+) High quality (++) Acceptable (+) Low quality (0) Acceptable (+) High quality (++) Level of evidence (SIGN, 2013)

102 Appendix 7: Summary of the Data of the Selected Intervention Studies Bibliographic citation Chang, et al. (1998) Glazener et al. (2011a) Hou et al. (2013) Ip (2004) Porru et al. (2001) Tibaek et al. (2007) Study design/ Evidence level Controlled trial, 2++ Number of patients/ Dropout rate N = 50 Dropout = 0% RCT, 1++ N = 442 Dropout: 45/442 = 10.18% RCT, 1- N = 66 Dropout: 5/66 = 7.58% RCT, 1- N = 442 Dropout: 0/16 = 0% RCT, 1+ N = 58 Dropout: 3/58 =5.17% RCT, 1+ N = 58 Dropout: 9/58 = 15.52% Intervention Comparison Data collection time n = 25 Post-op PFMT n = 220 Post-op PFMT (after 6 weeks) 4 teaching sessions in 3 months Biofeedback used in 13 men n = 32 Post-op PFMT Use EMG Phone interviews at least once/ week n = 9 Pre-op PFMT Visual reminder- magnet n = 28 Pre-op PFMT, Training sessions at 1,2,3 & 4 weeks after operation n = 26 Pre-op PFMT n = 25 No PFMT n = 222 No PFMT n = 29 No PFMT n = 7 Pre-op PFMT Paper reminder n = 27 No PFMT n = 23 No pre-op PFMT Verbal instruction 2-3 days after operation Before operation, 1, 2, 3, 4 weeks after operation Before intervention, 3, 6, 9, 12 months Before operation, 1, 4, 8, 12 weeks after operation Before operation, 2, 12 weeks after operation Before operation,1, 2, 3, 4 weeks after operation Before operation, 2, 4, 12 weeks after operation Outcome measures: Significant difference result between intervention & comparison groups Incidence of incontinence Urinary symptoms PFM Strength Quality of life voiding Voiding interval 4 weeks Patient satisfaction diaries at 3, 4 at 2, 3, 4 weeks score - total, psycho & weeks AUASS social at 2, 3, 4 weeks terminal dribbling at 4 weeks 3 days voiding diaries at 3, 6, 9 12 months ICI-UISF uroflowmetry parameters self-reporting IPSS - total & storage scores at 4 weeks Uroflowmetry parameters: Q max at 12 weeks St. George Urinary Incontinence Score voiding diaries at 1, 2, 3 weeks NA PFMT compliance NA IPSS NA PFMT compliance AUASS voiding interval at 2 & 4 weeks uroflowmetry parameters pad test DAN-PSS-1 voiding parameters at 4 weeks at 4 weeks ICIQ-UI SF ED-5D SF-12 QALYS SF-36 physical SF-36 mental at 12 weeks St. George Urinary Incontinence Score - lifestyle ICS- quality of life at 4 weeks NA 95

103 Appendix 8: Recommendation from Synthesis Process 8.1 What are the suggested interventions in the PFMT regime? Chang, et al. (1998) Glazener et al. (2011a) Hou et al. (2013) Ip (2004) Porru et al. (2001) Tibaek et al. (2007) PFMT starts Post-op 1-2 days Post-op 6 weeks after Post-op 2 days Pre-op Pre-admission clinic Pre-op Initial visit before surgery Pre-op Measure & grade PFM strength Pre-op Modified Oxford scale Post-op Modified Oxford scale Time of measurement Before & weekly for 4 weeks after TURP Before & each PFMT session Therapists Treatment - individual - group PFMT leaflet for home exercise Lifestyle / Bladder habit leaflet/ Biofeedback Monitor the compliance Not mentioned Individual Not mentioned PFM strength weekly Physiotherapists or continence nurses Individual for 4 sessions in 3 months Verbal and written Lifestyle& bladder training advice leaflet Biofeedback used in 13 men only Not mentioned Individual Not mentioned Apply EMG to confirm correct PFMT Nurses Not mentioned Lifestyle & bladder habits information Pre-op Modified Oxford scale Pre-op Modified Oxford scale Before & weekly for 4 weeks after TURP Before & weekly for 4 weeks after TURP One urologist for assessment. Training by physiotherapists One physiotherapists teaching and assessment Individual pre-op session 1 individual session & 3 group treatments sessions weekly for 4 weeks, each one hour Verbal and written Verbal and written PFM strength in first 3 months (4 sessions) only, then reported by questionnaire Phone at least once a week Telephone survey at 2 weeks and 3 months by senior nurses PFM strength weekly for 4 weeks PFM strength weekly for 4 weeks 96

104 8.2 What is the suggested content of the PFMT regime? Chang, et al. (1998) PFMT content Duration Frequency/ Day Slow/ strong contractions 3 positions (lying, sitting & standing) Knack Tighten the PFM strongly after voiding urine Bladder training sessions of 30 exercises each daily 4 weeks 3-4 times 10 Lifestyle leaflet Glazener et al. (2011a) Hou et al. (2013) - Three maximum strength contractions with a 10-second break between each one. - Target of duration of each contraction up to maximum of 10 seconds. - 5 minutes (contracts 5 seconds & relax 10 seconds) per one single PFE, 12 months 2 times 3 12 weeks 3 times? Ip (2004) - 5 slow contractions, relax, count for 5, repeat 6 times in a row 12 weeks 6 times 5 Porru et al. (2001) Tibaek et al. (2007) - 45 times a day and divided into 3 session of 15 contractions each - Strength exercise: maximum contraction (6 seconds contraction/6 seconds rest). - Endurance exercise: (maximum 30 seconds contraction/ 30 seconds rest) for as long a time as possible. - Repeat 6-10 times in the 3 positions, 4 weeks 3 times 15 4 weeks 1-2 times 6 97

105 8.3 What is the frequency for follow up? 1 st 2 nd 3 rd 4 th 8 th 12 th week Others week week week week week (3 months) Chang, et al. (1998) Glazener et al. (2011a) 3, 6, 9,12 months Hou et al. (2013) Ip (2004) Porru et al. (2001) Tibaek et al. (2007) 98

106 Appendix 9: Summary of Recommendation from Reviewed Studies Recommendation Grade Reviewed Studies (Level of Evidence) Chang, et al. (1998) (2++) Glazener et al. (2011a) (1++) Hou et al. (2013) (1-) Ip (2004) (1-) Porru et al. (2001) (1+) Tibaek et al. (2007) (1+) 1. Assessment and outcome measurements 1.1 Baseline assessment on urinary incontinence and urinary symptoms should be performed before TURP. A 1..2 Baseline assessment on the strength of pelvic floor muscle should be performed before TURP. A 1.3 General health questionnaires which consist of physical, A psycho-social and emotional dimensions are suggested for assessment the impact of quality of life related to urinary incontinence. 2. Pelvic floor muscle training instruction 2.1 Conduct an individual first teaching session on PFMT by trained A health care professional. 2.2 The strength of pelvic floor muscle contraction should be assessed and A taught by digital anal examination with verbal feedback. 2.3 Patients should be educated for PFMT as soon as before TURP. A 99

107 Recommendation (continued) Grade Reviewed Studies (Level of Evidence) Chang, et al. (1998) (2++) Glazener et al. (2011a) (1++) Hou et al. (2013) (1-) Ip (2004) (1-) Porru et al. (2001) (1+) Tibaek et al. (2007) (1+) 2.4 Patients should practice PFMT in three positions with 1-6 times per A days and the knack at home. 3. Patient education tools 3.1 Verbal and written instructions of PFMT should be given to patients A for home practice. 3.2 Visual reminder acts as a reminder to practice PFMT at home. C 4. Frequency of follow-up sessions 4.1 After initial PFMT pre-operative teaching session, a reminder session before discharge and a follow-up at 4 th week after operation are suggested to monitor patients progress. A 100

108 Appendix 10: ICIQ-UI Short Form 101

109 Appendix 11: The Chinese Version of the ICIQ-UI Short Form 102