Behaviour Modification for the Treatment of Urinary Incontinence Resulting from Neurogenic Bladder: A Review of Clinical Effectiveness and Guidelines

Transcription

1 CADTH RAPID RESPONSE REPORT: SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for the Treatment of Urinary Incontinence Resulting from Neurogenic Bladder: A Review of Clinical Effectiveness and Guidelines Service Line: Rapid Response Service Version: 1.0 Publication Date: September 20, 2017 Report Length: 19 Pages

2 Authors: Chuong Ho, Sarah Jones Cite As: Behaviour Modification for Urinary Incontinence from Neurogenic Bladder: A Review of Clinical Effectiveness and Guidelines. Ottawa: CADTH; 2017; Sep. (CADTH rapid response report: summary with critical appraisal). ISSN: (online) Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. While patients and others may access this document, the document is made available for informational purposes only and no representations or warranties are made with respect to its fitness for any particular purpose. The information in this document should not be used as a substitute for professional medical advice or as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision-making process. The Canadian Agency for Drugs and Technologies in Health (CADTH) does not endorse any information, drugs, therapies, treatments, products, processes, or services. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH. CADTH is not responsible for any errors, omissions, injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the contents of this document or any of the source materials. This document may contain links to third-party websites. CADTH does not have control over the content of such sites. Use of third-party sites is governed by the third-party website owners own terms and conditions set out for such sites. CADTH does not make any guarantee with respect to any information contained on such third-party sites and CADTH is not responsible for any injury, loss, or damage suffered as a result of using such third-party sites. CADTH has no responsibility for the collection, use, and disclosure of personal information by third-party sites. Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada s federal, provincial, or territorial governmentsor any third party supplier of information. This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user s own risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors. About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs, medical devices, diagnostics, and procedures in our health care system. Funding: CADTH receives funding from Canada s federal, provincial, and territorial governments, with the exception of Quebec. SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 2

3 Context and Policy Issues Neurologic bladder, or neurologic lower urinary tract dysfunction, is a consequence of a variety of a variety of neurological diseases (e.g., multiple sclerosis, diabetes, Parkinson s disease, spinal cord diseases), leading to urinary incontinence, kidney dysfunctions, and urinary tract infection. 1,2 Urinary incontinence, or involuntary leakage of urine, is a highly prevalent condition affecting 3.3 million, or 10% of Canadians and can include stress urinary incontinence (SUI) (the most common type of UI; happens when the bladder and muscles involved in urinary control are under sudden stress such as coughing, sneezing, heavy lifting, etc), urgency urinary incontinence (UUI) (due to overactive bladder muscle leading to an urge to urinate when there is a change in body position, sound of running water, etc), or mixed urinary incontinence (MUI) (a combination of SUI and UUI). 3-5 Treatment for urinary incontinence aims to achieve continence, improve quality of life, prevent urinary infection and preserve renal function. Management of urinary incontinence usually involves a multidisciplinary team and includes conservative management, pharmacological (such as anticholinergics), or surgical treatments. 3,6 Conservative management for urinary incontinence usually includes behaviour modification (such as pelvic floor muscle training, bladder training), lifestyle changes, mechanical devices, and electrical stimulation. Pelvic floor muscle training involves exercises (Kegel exercises) that help strengthening muscles that control the flow of urine, while bladder training involves increased time interval between scheduled bathroom visits Despite being commonly used in clinical practice, it has not been clear as to whether behaviour modification should precede pharmacological treatment in the management for urinary incontinence. This Rapid Response report aims to review the clinical effectiveness of behavioural modification for the treatment of urinary incontinence resulting from neurogenic bladder. Evidence-based guidelines regarding the use of behavioural modification for the treatment of urinary incontinence resulting from neurogenic bladder will also be examined. Research Questions 1. What is the clinical effectiveness of behavioural modification for the treatment of adults with urinary incontinence resulting from neurogenic bladder? 2. What are the evidence-based guidelines associated with the use of behavioural modification for the treatment of adults with urinary incontinence resulting from neurogenic bladder? Key Findings There was no evidence found that directly compared behavioural modification to pharmacologic treatment such as anticholinergics for the treatment of adults with urinary continence from neurogenic bladder. Data from a 2014 systematic review on the effects of pelvic floor muscle training (PFMT) suggested that it lead to better control of stress urinary incontinence (SUI) in women as compared to no treatment or inactive control treatments, as determined by patient-reported SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 3

4 or clinician-reported measures, with few adverse effects. When the type of urinary incontinence was unspecified, the effect size was reduced. There were no data on urgency urinary incontinence (UUI) or mixed urinary incontinence (MUI) alone. Women with either SUI or any type of urinary incontinence were also more satisfied with PFMT treatment than controls, while women in the control groups were more likely to seek further treatment. The American College of Physicians (ACP) recommends PFMT as first-line therapy for SUI, and recommends against treatment with systemic pharmacologic therapy. For UUI, ACP recommends bladder training as first-line therapy, and pharmacologic treatment if bladder training was unsuccessful. ACP recommends PFMT plus bladder training for MUI (no algorithm relative to pharmacologic therapy stated). Methods A limited literature search was conducted on key resources including PubMed, The Cochrane Library, University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. No methodological filters were applied to limit retrieval by study type. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2012 and August 18, Rapid Response reports are organized so that the evidence for each research question is presented separately. Selection Criteria and Methods One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1. Table 1: Selection Criteria Population Intervention Comparator Outcomes Study Designs Adults with urinary incontinence from neurogenic bladder Behavioural modification Q1: Standard of care (anticholinergics) Placebo Q2: No comparator Q1: Clinical effectiveness Q2: Guidelines Heath technology assessments, systematic reviews, meta-analyses, randomized controlled trials, nonrandomized controlled trials, evidence-based guidelines Exclusion Criteria Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications were already reported in the included SRs, or were published SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 4

5 prior to Guidelines were excluded if they were not evidence-based (i.e., based on a formal search for relevant literature with assessments of evidence quality). Critical Appraisal of Individual Studies The included systematic review (SR) and guidelines were assessed using the AMSTAR 11 and AGREE 12 checklists, respectively. Summary scores were not calculated for the included studies; rather, a review of the strengths and limitations of each included study were described narratively. Summary of Evidence Quantity of Research Available A total of 656 citations were identified in the literature search. Following screening of titles and abstracts, 648citations were excluded and eight potentially relevant reports from the electronic search were retrieved for full-text review. One potentially relevant publication was retrieved from the grey literature search. Of these potentially relevant articles, seven publications were excluded for various reasons, while two publications met the inclusion criteria and were included in this report. Appendix 1 describes the PRISMA flowchart of the study selection. Summary of Study Characteristics The included review 13 is a SR with meta-analysis that aims to evaluate the efficacy of PFMT in women with urinary incontinence in comparison to no treatment, placebo or sham treatments, or other inactive control treatments (such as advice on use of pads). The SR included 20 randomized controlled trials (RCTs) and 1 quasi-rct. Primary outcomes reported were efficacy of PFMT determined by patient-reported measures and urinary incontinence-related quality of life; clinician-reported measures such dry pads, and adverse events were also reported. The review was done in Canada and New Zealand. The included guideline is a Clinical Practice Guideline developed by the American College of Physicians (ACP) on non-surgical management of urinary incontinence in women. 14 The guideline was based on a comprehensive systematic evidence search from 1990 to The guideline rates the evidence by using the ACP s guideline grading system adopted from the GRADE (Grading of Recommendations, Assessments, Development, and Evaluation) workgroup. Characteristics of the included studies are detailed in Appendix 2. Summary of Critical Appraisal The included SR 13 had a priori design provided, independent studies selection and data extraction procedure in place, comprehensive literature search performed, list of included and excluded studies, studies characteristics provided, quality assessment of included studies provided and used in formulating conclusions, assessment of publication bias performed, and conflict of interest stated. Heterogeneity across trials in interventions, comparators, and length of follow-up was present in a number of pooled analyses, so a random-effects model was used. The guideline had clear scope and purpose, the recommendations are specific and unambiguous, the method for searching for and selecting the evidence are clear, methods SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 5

6 used for formulating the recommendations are clearly described, health benefits, side effects and risks were stated in the recommendations, and the procedures for updating the guidelines provided and target users of the guideline are clearly defined. Potential cost implications of applying the recommendation were included. It was unclear whether the guideline was piloted among target users, or whether patients views and preferences were sought. Details of the critical appraisal of the included studies are presented in Appendix 3. Summary of Findings What is the clinical effectiveness of behavioural modification for the treatment of adults with urinary incontinence resulting from neurogenic bladder? There was no evidence found that compared behavioural modification to pharmacologic treatment such as anticholinergics for the treatment of adults with urinary incontinence resulting from neurogenic bladder. The 2014 Cochrane systematic review determined the effects of PFMT for women with urinary incontinence in comparison to no treatment, placebo, sham treatments, or other inactive control treatments. 13 The SR included 15 trials on SUI and six trials on unspecified urinary incontinence; there was no trial on patients with UUI or MUI alone. Women with SUI who were in the PFMT groups were eight times more likely than the controls to report that they were cured, by several definitions (e.g., dry, no leakage, unproblematic, >75% improvement) and 17 times more likely to report cure or improvement at the end of treatment. Women with any incontinence in the PFMT group were also more likely to report that they were cured, or more likely to report cure and improvement than the control group at the end of treatment. Six months to one year after the end of treatment, women with SUI who were in the PFMT groups were 28 times more likely than the control group to report cure or improvement, and 24 times more likely than the control to report cure or improvement in women with any incontinence. Women were more satisfied with PMFT, while women in the control groups were more likely to seek further treatment. Women with PFMT leaked urine less often, lost smaller amounts on short office-based pad tests, emptied their bladders less often during the day, and their sexual outcomes were better than women in the control group. Adverse events were rare (one trial reported adverse events with PMFT) and minor (pain, uncomfortable feeling after exercise, or bothered ). The authors concluded that based on the available evidence, PFMT is better than no treatment, placebo drug, or inactive control treatments for women with SUI or urinary incontinence (all types), but there was no information about women with UUI alone or MUI. What are the evidence-based guidelines associated with the use of behavioural modification for the treatment of adults with urinary incontinence resulting from neurogenic bladder? The 2014 Clinical Practice Guideline from the American College of Physicians (ACP) issued recommendations for nonsurgical management of urinary incontinence in women. 14 Recommendation 1: ACP recommends first-line treatment with PFMT in women with stress UI. (Grade: strong recommendation, high-quality evidence). (p 434) SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 6

7 Recommendation 2: ACP recommends bladder training in women with urgency UI. (Grade: strong recommendation, moderate-quality evidence).(p 434) Recommendation 3: ACP recommends PFMT with bladder training in women with mixed UI. (Grade: strong recommendation, moderate-quality evidence)(p 434) Recommendation 4: ACP recommends against treatment with systemic pharmacologic therapy for stress UI. (Grade: strong recommendation, low-quality evidence)(p 434) Recommendation 5: ACP recommends pharmacologic treatment in women with urgency UI if bladder training was unsuccessful. Clinicians should base the choice of pharmacologic agents on tolerability, adverse effect profile, ease of use, and cost of medication. (Grade: strong recommendation, high quality evidence)(p 434) Recommendation 6: ACP recommends weight loss and exercise for obese women with UI. (Grade: strong recommendation, moderate-quality evidence)(p 434) The main findings of the included studies are presented in Appendix 4. Limitations There was no evidence found that directly compared behavioural modification to pharmacologic treatment such as anticholinergics. No trials evaluated efficacy of behavioural modification one year or more after the end of treatment. The major limitation in reporting of the included trials was the lack of a clear description of the PFMT programs. Heterogeneity across trials in PFMT programs, comparators, length of follow-up, was present in a number of pooled analyses. Conclusions and Implications for Decision or Policy Making There was no evidence found that directly compared behavioural modification to pharmacologic treatment such as anticholinergics for the treatment of adults with urinary incontinence resulting from neurogenic bladder. Data from a 2014 systematic review on the effects of PFMT lead to better control of SUI in women as determined by patient-reported (such as likeliness to report continence) or clinician-reported measures (such as pad testing for urine loss), with few adverse effects. When the type of urinary incontinence was unspecified, the effect size was reduced. There were no data on UUI or MUI alone. Women with either SUI or any type of urinary incontinence were also more satisfied with PFMT treatment, while women in the control groups were more likely to seek further treatment. The efficacy of behavioural modification such as PFMT, bladder training and biofeedback may also be enhanced with the addition of other conservative strategies such as lifestyle changes (e.g., weight loss, dietary changes, physical activity), physical therapy (e.g., vaginal cones) and electrical stimulation. 7,15,16 Despite the evidence that behavioural modification helps to control urinary incontinence, there are factors that influence its uptake and delivery. A qualitative review on patients and staff perception on behavioural modification found that from clients perspective, increase fear of accidents and convenience of treatments are barriers to participation in the program, and from a staff perspective, barriers to adopting behavioural interventions included staff education and perceptions of treatmenteffectiveness. 17 SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 7

8 The American College of Physicians (ACP) recommends PFMT as first-line therapy for SUI, and recommends against treatment with systemic pharmacologic therapy. For UUI, ACP recommends bladder training as first-line therapy, and pharmacologic treatment if bladder training was unsuccessful. ACP recommends PFMT plus bladder training for MUI (no algorithm relative to pharmacologic therapy stated). SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 8

9 REFERENCES 1. Tudor KI, Sakakibara R, Panicker JN. Neurogenic lower urinary tract dysfunction: evaluation and management. J Neurol Dec;263(12): Ginsberg D. The epidemiology and pathophysiology of neurogenic bladder. Am J Manag Care [Internet] [cited 2017 Aug 22];19(10 Suppl):s191-s196. Available from: 3. Pannek J, Blok B, Castro-Diaz D, Del Popolo G, Kramer G, Radziszewski P, et al. Guidelines on neurogenic lower urinary tract dysfunction [Internet]. The Netherlands: European Association of Urology; 2011 Mar. [cited 2017 Aug 18]. Available from: 4. Cameron Institute. Incontinence: the Canadian perspective [Internet]. Peterborough (ON): The Canadian Continence Foundation; 2014 Dec. [cited 2017 Aug 21]. Available from: 5. Ramage-Morin PL, Gilmour H. Urinary incontinence and loneliness in Canadian seniors [Internet]. Ottawa: Statistics Canada; 2015 Nov 27. [cited 2017 Aug 21]. Available from: 6. Wallace KM, Drake MJ. Overactive bladder. F1000Res [Internet] [cited 2017 Aug 22];4. Available from: 7. Faiena I, Patel N, Parihar JS, Calabrese M, Tunuguntla H. Conservative management of urinary incontinence in women. Rev Urol [Internet] [cited 2017 Aug 22];17(3): Available from: 8. Newman DK, Wein AJ. Office-based behavioral therapy for management of incontinence and other pelvic disorders. Urol Clin North Am Nov;40(4): Burgio KL. Update on behavioral and physical therapies for incontinence and overactive bladder: the role of pelvic floor muscle training. Curr Urol Rep Oct;14(5): Behavioral methods for urinary incontinence [Internet]. Atlanta (GA): WebMD; 2015 Nov 20. [cited 2017 Aug 22]. Available from: Shea BJ, Grimshaw JM, Wells GA, Boers M, Andersson N, Hamel C, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol [Internet] [cited 2017 Sep 19];7:10. Available from: Brouwers M, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. AGREE II: advancing guideline development, reporting and evaluation in healthcare. CMAJ [Internet] Dec [cited 2017 Sep 19];182(18):E839-E842. Available from: Dumoulin C, Hay-Smith EJ, Mac Habee-Seguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev May 14;(5):CD Qaseem A, Dallas P, Forciea MA, Starkey M, Denberg TD, Shekelle P, et al. Nonsurgical management of urinary incontinence in women: a clinical practice guideline from the American College of Physicians. Ann Intern Med Sep 16;161(6): Imamura M, Williams K, Wells M, McGrother C. Lifestyle interventions for the treatment of urinary incontinence in adults. Cochrane Database Syst Rev Dec 2;(12):CD Stenzelius K, Molander U, Odeberg J, Hammarstrom M, Franzen K, Midlov P, et al. The effect of conservative treatment of urinary incontinence among older and frail older people: a systematic review. Age Ageing Sep;44(5): French B, Thomas LH, Harrison J, Coupe J, Roe B, Booth J, et al. Client and clinical staff perceptions of barriers to and enablers of the uptake and delivery of behavioural interventions for urinary incontinence: qualitative evidence synthesis. J Adv Nurs Jan;73(1): SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 9

10 Appendix 1: Selection of Included Studies 656 citations identified from electronic literature search and screened 648 citations excluded 8 potentially relevant articles retrieved for scrutiny (full text, if available) 1 potentially relevant report retrieved from other sources (grey literature, hand search) 9 potentially relevant reports 7 reports excluded: -irrelevant population (1) - irrelevant intervention (1) - irrelevant comparator (4) - review (1) 2 reports included in review SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 10

11 Appendix 2: Characteristics of Included Publications Table 2: Characteristics of Included Systematic Review First Author, Year, Country, Dumoulin, , Canada, New Zealand Objectives Literature Search Strategy To determine the effects of pelvic floor muscle training for women with urinary incontinence in comparison to no treatment, placebo or sham treatments, or other inactive control treatments (p 1) We searched thecochrane Incontinence Group Specialised Register, which contains trials identified Cochrane Central Register of Controlled Trials (CENTRAL) (1999 onwards), MEDLINE (1966 onwards) and MEDLINE In-Process (2001 onwards), and Handsearched journals and conference proceedings (searched 15 April 2013) and the reference lists of relevant articles ( p 1) Inclusion Criteria Exclusion Criteria Studies included Main outcomes Randomised or quasirandomised trials in women with stress, urgency or mixed urinary incontinence (based on symptoms, signs, or urodynamics). One arm of the trial included pelvic floor muscle training (PFMT). Another arm was a no treatment, placebo, sham, or other inactive control treatment arm ( p 1) Trials in which PFMT was combined with another conservative therapy (for example bladder training, biofeedback, vaginal cones or electrical stimulation) or drug therapy (for example an anticholinergic) were excluded (p 9) 21 studies included (20 RCTs, 1 quasi-rct) Primary outcomes Patient reported measures at the end of treatment: Symptomatic cure or improvement of urinary incontinence(likert scales, visual analogue scales, and per cent reduction in symptoms) Quality of life, incontinencespecific (King s Health Questionnaire, IQOL, B- FLUTS questionnaire) Secondary outcomes Patient-reported symptomatic cure or improvement measures six months to one year after the end of treatment or more than one year. Quality of life, not conditionspecific (General Health Status Measures Short Form-36, SCL-90-R, HADS); sexual functions (leakage during intercourse) Clinicians measures Pad and paper towel testing short (up to one hour) or long (24 hours) urine loss (grams of urine lost) Number cured or improved based on pad weights in short office-based pad test Adverse events B-FLUTS = British Female Lower Urinary Tract Symptoms Questionnaire; HADS = Hospital Anxiety and Depression Scale; IQOL = Incontinence Quality of Life Questionnaire; RCT = randomized controlled trial; SCL-90-R = Hopkins Symptoms Checklist for psychological distress. SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 11

12 Table 3: Characteristics of Included Guideline First Author, Year Scope Population Evidence Grading system Qaseem, , developed by The American College of Physicians Management of urinary incontinence Women GRADE = Grading of Recommendations, Assessment, Development, and Evaluation. Systematic evidence review done by the Minnesota Evidence-based Practice Center; literature search from 1990 to 2013 The evidence and recommendation were rated using the ACP s guideline grading system adopted from the classification developed by the GRADE workgroup SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 12

13 Appendix 3: Critical Appraisal of Included Publications Table 4: Summary of Critical Appraisal of Included Studies First Author, Publication Year Strengths Limitations Critical appraisal of included systematic review (AMSTAR 11 ) Dumoulin 13 a priori design provided independent studies selection and data extraction procedure in place comprehensive literature search performed list of included studies, studies characteristics provided list of excluded studies provided quality assessment of included studies provided and used in formulating conclusions assessment of publication bias performed conflict of interest stated Critical appraisal of included guidelines (AGREE 12 ) Qaseem 14 scope and purpose of the guidelines are clear the recommendations are specific and unambiguous the method for searching for and selecting the evidence are clear methods used for formulating the recommendations are clearly described health benefits, side effects and risks were stated in the recommendations procedure for updating the guidelines provided target users of the guideline are clearly defined potential cost implications of applying the recommendation are included heterogeneity across trials in interventions, comparators, length of follow-up, was present in a number of pooled analyses unclear whether the guideline was piloted among target users unclear whether patients views and preferences were sought SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 13

14 Appendix 4: Main Study Findings and Author s Conclusions Table 5: Main Study Findings and Authors Conclusions Main Study Findings Dumoulin 13 Primary outcomes (patient-reported measures) (Cure was defined as no leakage or incontinence unproblematic ) Symptomatic cure at the end of treatment Women with SUI who were in the PFMT groups were 8 times more likely than the control to report that they were cured (46/82 [56.1%] vs 5/83 [6.0%], RR 8.38, 95% CI 3.68 to 19.07) (data from 4 trials) Women with any incontinence in the PFMT group were 5 times more likely than the control to report that they were cured (50/144 [35.0%] vs 9/146 [6.0%],RR 5.34,95% CI 2.78 to (data from 3 trials) Authors Conclusions Based on the data available, PFMT is better than no treatment, placebo drug, or inactive control treatments for women with stress urinary incontinence or urinary incontinence (all types), but there was no information about women with urgency urinary incontinence alone or mixed urinary incontinence (p 31) Symptomatic cure or improvement at the end of treatment Women with SUI who were in the PFMT groups were 17 times more likely than the control to report cure or improvement (32/58 [55%] vs 2/63 [3.2%], RR 17.33, 95% CI 4.31 to 69.64) (data from 2 trials) Women with any incontinence in the PFMT group were 2 times more likely than the control to report cure or improvement (58/86 [67.4%]vs 23/80 [28.7%], RR 2.39, 95% CI 1.64 to 3.47) (data from 2 trials) Quality of life, incontinence-specific The review provides support for the widespread recommendation that PFMT be included in first-line conservative management programmes for women with stress and any type of urinary incontinence. Long-term effectiveness of PFMT needs to be further researched (p 2) Three out of four different measures of quality of life specific to the effect of urinary incontinence (severity, physical limitation, incontinence impact) were in favour of PFMT in women with urinary incontinence (SUI and all types). Secondary outcomes Patient-reported measures Symptomatic cure or improvement 6 months to 1 year after the end of treatment Women with SUI who were in the PFMT groups were 28 times more likely than the control to report cure or improvement (14/26 [53.8%] vs 0/25 [0%], RR 27.93, 95% CI 1.75 to ) (data from 1 trial) Women with any incontinence in the PFMT group were 24 times more likely than the control to report cure or improvement (23/59 [38.9%]vs 1/61 [1.6%], RR 23.78, 95% CI 3.32 to ) (data from 1 trial) Satisfaction Women with SUI who were in the PFMT groups were 5 times more likely than the control to report cure or improvement (36/51 [70.6%] vs 7/54 [12.9%], RR 5.32, 95% CI 2.63 to 10.74) (data from 2 trials) Women with any incontinence in the PFMT group were 3 times more likely than the control to report cure or improvement (45/58 [77.6%]vs 14/50 [28%], RR 2.77, 95% CI 1.74 to 4.41) (data from 1 trial) Need further treatment Women with SUI in the PFMT group were less likely than the control to require further treatment (RR 0.17, 95% CI 0.07 to 0.42) (data from 1 trial) SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 14

15 Main Study Findings Women with any incontinence who were in the PFMT groups wereless likely than the control to require further treatment (RR 0.19, 95% CI 0.10 to 0.36) (data from 1 trial) Authors Conclusions Number of leakage per 24 hours Women with SUI doing PFMT experienced about one leakage episode less per 24 hours compared to controls (RR -1.21, 95% CI to -0.89) (data from 4 trials) Women with any incontinence doing PFMT experienced about one leakage episode less per 24 hours compared to controls (RR -0.80, 95% CI to -0.34) (data from 1 trial) General health status measures and psychological distress No statistical difference between PFMT and control groups in general health status (data from 1 trial) or psychological distress (data from 1 trial) in either women with SUI or with all types of incontinence. Sexual function Women with SUI suggested that sexual function was improved (less spoiled by PFMT) compared to control group (RR 0.38, 95% CI 0.15 to 1.0) (data from 1 trial) Women with SUI suggested that there was reduction of urine leakage during intercourse by PFMT compared to control group (RR 0.25, 95% CI 0.06 to 1.01) (data from 1 trial) Adverse effects Four trials reported adverse events, and three did not report any in the PFMT group. No serious adverse events reported. Clinician-reported measures Number cured or improved based on pad weights in short office-based pad test (objectively diagnosed urinary incontinence) It was over 7 times more likely for women with SUI to be cured with PFMT (dry pads up to 1 hour) than the control(rr 7.50, 95% CI 2.89 to 19.47) (data from 3 trials) It was 8 times more likely for women with SUI to be cured or improved with PFMT (dry pads up to 1 hour) than the control(rr 8.22, 95% CI 3.17 to 21.28) (data from 3 trials) There was no statistically significant difference between PFMT and control on 24-hour dry pad tests. Qaseem 14 Recommendation 1: ACP recommends first-line treatment with PFMT in women with stress UI. (Grade: strong recommendation, high-quality evidence). (p 434) Nonpharmacologic therapy with PFMT should be first-line treatment for women with UI.(p 435) Recommendation 2: ACP recommends bladder training in women with urgency UI. (Grade: strong recommendation, moderate-quality evidence). Bladder training improved UI for women with urgency UI. The addition of PFMT to bladder training did not improve continence compared with bladder training alone for urgency UI. (p 435) Clinicians should use nonpharmacologic management for UI, such as PFMT for stress UI, bladder training for urgency UI, and PFMT with bladder training for mixed UI, because these therapies are effective, have few adverse effects, and are cheaper than pharmacologic therapies (p 435) Recommendation 3: ACP recommends PFMT with bladder training in women with mixed UI. (Grade: strong recommendation, moderate-quality evidence) SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 15

16 Main Study Findings Pelvic floor muscle training combined with bladder training improved continence and UI in women with mixed UI. (p 435) Authors Conclusions Recommendation 4: ACP recommends against treatment with systemic pharmacologic therapy for stress UI. (Grade: strong recommendation, low-quality evidence) Treatment of stress UI with standard pharmacologic therapies used for urgency UI has not been shown to be effective. Vaginal estrogen formulations improved continence and stress UI, but transdermal estrogen patches worsened UI. (p 435) Recommendation 5: ACP recommends pharmacologic treatment in women with urgency UI if bladder training was unsuccessful. Clinicians should base the choice of pharmacologic agents on tolerability, adverse effect profile, ease of use, and cost of medication. (Grade: strong recommendation, high-quality evidence)(p 435) Recommendation 6: ACP recommends weight loss and exercise for obese women with UI. (Grade: strong recommendation, moderate-quality evidence)(p 435) ACP = the American College of Physicians; 95% CI = 95% confidence interval; MUI = mixed urinary incontinence; PFMT = pelvic floor muscle training; RR = risk ratio; SUI = stress urinary incontinence; UUI = urgency urinary incontinence. SUMMARY WITH CRITICAL APPRAISAL Behaviour Modification for Urinary Incontinence from Neurogenic Bladder 16