A recent randomized controlled trial of a SMP for patients with LUTS reported positive results. In the group of patients who used the

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1 . JOURNAL COMPILATION 2009 BJU INTERNATIONAL Lower Urinary Tract SELF-MANAGEMENT OF LUTS AND FREQUENCY-VOLUME CHART MEASURES YAP et al. BJUI BJU INTERNATIONAL The impact of self-management of lower urinary tract symptoms on frequency-volume chart measures Tet L. Yap*, Christian Brown*, David A. Cromwell*, Jan van der Meulen* and Mark Emberton* *Clinical Effectiveness Unit, Royal College of Surgeons of England, and Division of Surgery and Interventional Science, Comprehensive Biomedical Centre, University College London Hospitals, London, UK Accepted for publication 15 January 2009 OBJECTIVE To assess the effect of a self-management programme (SMP) on actual voiding behaviour using frequency-volume chart (FVC) data. PATIENTS AND METHODS In all, 140 men with uncomplicated lower urinary tract symptoms (LUTS) were recruited and randomised to either attend a SMP in addition to standard care, or standard care alone. The SMP group received three small group sessions that addressed behaviour and gave training in problemsolving strategies. Patients were assessed in urological clinics at baseline and 3, 6 and 12 months, completing the International Prostate Symptom Score (IPSS) and 3-day FVCs after assessment. Differences in voiding behaviour between the SMP and control groups were calculated analysed by intention-to-treat. RESULTS Of the 140 patients, 104 completed the FVC data at baseline; at 3, 6 and 12 months charts were received from 99, 95 and 70, respectively. Baseline FVC variables were equivalent between the randomized groups. At 3 months the mean voided volume had increased in the SMP group and differed from the control group by a mean (95% confidence interval, CI) of 57 (33 83) ml. The total number of voids and episodes of nocturia were also lower in the SMP group, with a mean (95% CI) decrease of 2.6 ( 3.6 to 1.5) and 0.7 ( 1.1 to 0.3) episodes, respectively. These changes were maintained at 6 and 12 months. CONCLUSION A SMP in addition to standard care significantly improved the urinary symptoms of frequency and nocturia according to FVC monitoring. The exact mechanism of action and the specific interventions which affect this require further investigation. KEYWORDS self-management, frequency-volume chart, benign prostatic hyperplasia, lower urinary tract symptoms INTRODUCTION LUTS become an increasingly common problem among men as they age; they can be related to bladder function and storage (e.g. frequency, nocturia) and/or voiding (e.g. hesitancy). The management of LUTS aims to relieve symptoms and improve the quality of life, while also aiming to reduce the risk of progression and complications. Treatment selection depends on a careful assessment but often starts with watchful waiting or active monitoring before escalating to medical therapy. Surgery is indicated when medical treatment is not tolerated, proves ineffective or when complications have arisen [1 3]. A recent survey carried out among British healthcare professionals involved in the care of men with LUTS reported that many routinely advise lifestyle modifications (e.g. fluid management, caffeine avoidance, bladder re-training) as part of watchful waiting. However, there was considerable variation in the type of advice given [4]. Simply informing and advising patients about lifestyle modifications is rarely sufficient to improve their health status [5]. This has led to the development of self-management programmes (SMPs), interventions that combine providing information and advice with techniques that can help to promote behavioural change. These SMPs aim to help patients manage their disease by enhancing their problem-solving and goal-setting skills. SMPs with these attributes have been shown to be effective for several chronic conditions [5]. A recent randomized controlled trial of a SMP for patients with LUTS reported positive results. In the group of patients who used the SMP, self-rated LUTS were found to improve, and a lower proportion of patients progressed to either medication or surgery over 12 months [1]. In this report we present the frequency-volume chart (FVC) data from the same randomized control trial, assessing whether there were differences between the SMP and control groups in actual voiding behaviour, and the self-rated severity of symptoms. PATIENTS AND METHODS Men with uncomplicated LUTS were recruited from the outpatient department of two urological centres in London between February 2003 and June All patients aged >40 years who attended either centre for the first time after referral by their GP, and were diagnosed with LUTS, were eligible for inclusion. Men were excluded if: (i) they had 1104 JOURNAL COMPILATION 2009 BJU INTERNATIONAL 104, doi: /j x x

2 SELF-MANAGEMENT OF LUTS AND FREQUENCY-VOLUME CHART MEASURES FIG. 1. A flow diagram of recruitment, randomization and follow-up of patients. Excluded: n = 46 Work commitments (n = 17) Disliked the idea of self management (n = 19) Requested medication (n = 10) Allocated to self-management in addition to standard care n = 73 Received allocated treatment: n = 68 Analysed (3 month data): n = 71 Lost to follow up (n = 2) Analysed (6 month data): n = 69 Reason: Lost to follow up (n = 4) Analysed (12 month data): n = 59 Reason: Lost to follow up (n = 14) Assessed for eligibility: n = 186 Randomised: n = 140 received any form of medical therapy (α-blocker, 5α-reductase inhibitor or anticholinergic) within the last 3 months, or previous prostatic surgery or pelvic radiotherapy; (ii) they had severe LUTS necessitating immediate medical or surgical treatment; (iii) they had complications potentially related to their symptoms (PSA level >4 ng/ml, postvoid residual volume >200 ml, serum creatinine level >130 µmol/l, bladder stones, haematuria, urinary retention, recurrent UTIs); (iv) they were unable to speak or understand English; or (v) they had uncontrolled diabetes, dementia and endstage cardiac or respiratory failure. Enrolled men were randomized either to attend a SMP in addition to standard care, or to standard care alone. Standard care began with watchful waiting, with escalation to medical treatment and surgery left entirely to the discretion of the clinician and patient. In Allocated to standard care alone n = 67 Received allocated treatment: n = 67 Analysed (3 month data): n = 65 Lost to follow up (n = 2) Analysed (6 month data): n = 64 Reason: Lost to follow up (n = 3) Analysed (12 month data): n = 56 Reason: Lost to follow up (n = 11) New referrals of men with LUTS addition to standard care, men in the SMP group attended small-group sessions (five to eight men) during which they were taught various lifestyle modifications and problemsolving strategies to overcome any barriers to adopting these modifications (Appendix [6]). The groups were scheduled 1, 2 and 6 weeks after randomization and were run by urology nurse specialists trained in group-facilitation skills, and the techniques to enhance selfmanagement skills. Full details are published elsewhere [1]. Clinicians randomized patients after they consented to being in the trial by telephoning a third-party and obtaining the allocation code. The randomization procedure was changed halfway through the recruitment period because of difficulties in contacting the central randomization office out of hours. For that reason, the randomization was carried out within the participating hospitals. However, we ensured that the randomization lists were never available to the investigators involved in the recruitment of patients (C.B. and T.Y.). The sample size calculation was based on the primary outcome measure, the IPSS; a 3-point reduction in the IPSS was considered to represent an improvement in symptoms that is meaningful to patients [4]. Outcomes were measured at 3, 6 and 12 months, in the urology outpatient department by a clinician who was not involved in the conduct of the trial. Participants were asked not to reveal to the clinicians in which treatment group they had been randomized. Patients completed an IPSS questionnaire, and a 3-day FVC. Patients recorded their waking time and time to bed for 3 days, along with the type and volume of liquids drunk, to the closest hour, and volume of urine voided to the closest hour (measured using a calibrated jug). Patients were instructed to complete the FVC within a fortnight after being seen in the outpatient department. Completed FVCs were mailed to and entered into a database by a data collector unaware of treatment allocation. The outcomes at 3, 6 and 12 months were analysed separately, on an intention-to-treat basis. The variables extracted from the FVCs were total fluid intake in 24 h, total volume of voids in 24 h, mean voided volume, largest voided volume and nocturnal volume, total voids in 24 h, nocturia, and number of urgent voids. All were derived according to definitions of the ICS [5], with time of waking and time to bed defined by the patient. The mean (SD) was used to summarize quantitative variables and proportions to summarize categorical variables. Student's t-tests (for continuous data) were used to compare means and Fisher's exact tests to compare the distributions of categorical data. Multiple linear regression was used to adjust the comparisons for potential imbalances in the baseline characteristics (age, symptom duration, level of education, and number of comorbidities). RESULTS There were 186 referred men who were eligible for the trial during the recruitment period, of which 140 were included; 73 were randomised to participate in the SMP and 67 to standard care alone (Fig. 1). Compliance with the SMP was high, with 68 patients JOURNAL COMPILATION 2009 BJU INTERNATIONAL 1105

3 Y AP ET AL. (93%) attending all three meetings. The distribution of the patient demographics in the SMP and standard-care group were broadly similar, as were the baseline FVC values (Table 1). FVCs were completed at baseline by 60 men randomized to SMP and 44 to standard care. At the 3, 6 and 12 month follow-up visits, charts were completed by 59, 50 and 45 men in the SMP group, respectively, and by 49, 45 and 30 men in the standard-care group, respectively. There was no significant difference in mean age, mean symptom duration and mean IPSS (t-test, all P > 0.05), and for the distribution of ethnicity, education and comorbidities (Fisher's exact test, all P > 0.05) between men who completed the FVC and those who did not at baseline, 3, 6 and 12 months. At 3 months, the mean total IPSS of patients in the SMP group was 5.7 points lower than the mean self-rated IPSS for the control group. This magnitude of difference was maintained at 6 and 12 months. The FVC data collected at 3 months showed that patients in the SMP group had fewer episodes of voiding in 24 h and fewer episodes of nocturia than patients who received only standard care (Table 2). The mean volume per void in the SMP group was 57 ml higher than in the control group at 3 months. These changes were maintained at 6 and 12 months. The differences between the groups were not statistically significant in volume voided in 24 h, largest volume voided, urgency, or nocturnal volume at 3, 6 and 12 months. The differences between the groups in terms of 24-h frequency, nocturia and volumes per void at 3, 6 and 12 months varied only slightly when they were adjusted for baseline characteristics of age, ethnicity, occupation, education level and comorbidities. For example, the difference in mean voided volume, adjusted for baseline characteristics between groups at 6 months was 34.8 ml (95% CI ). Mean (SD) or n (%) variable SMP Standard care N patients Age at enrolment, years 63.3 (11.1) 63.4 (10.4) Range Ethnicity Caucasian 57 (78) 51 (76) Not Caucasian (Black, Asian, 16 (22) 16 (24) other) Level of education None 16 (22) 22 (33) School or professional 19 (26) 26 (39) qualification University degree 33 (45) 16 (24) Missing 5 (7) 3 (4) N comorbidities/patient None 19 (26) 23 (34) One 21 (29) 18 (27) Two 17 (23) 15 (22) Three or more 16 (22) 11 (16) Symptom duration, years 3.9 (4.0) 4.3 (6.7) IPSS 16.9 (5.1) 15.9 (6.5) Volume voided/24 h, ml 1817 (695) 1609 (652) Voided volume/ml 189 (62) 176 (59) Largest voided volume/ml 388 (159) 357 (140) Nocturnal volume/ml 618 (290) 576 (286) Fluid intake volume in 24 h/ml 1965 (771) 1816 (687) Total number of voids/24 h 9.7 (2.4) 9.3 (2.8) Episodes of nocturia/24 h 1.9 (0.8) 1.7 (1.2) Episodes of urgency/24 h 2.5 (2.9) 2.3 (3.0) Missing values 13 (18) 23 (34) objectively measured voiding variables. The magnitude of changes in these FVC variables (>25% reduction in frequency and nocturia, >20% increase in mean voided volume) are larger than some reported improvements seen when α-blockers were compared to placebo for medical therapy of BPH. For example, Buzelin et al. [7] reported an increase in the mean voided volume of 6.5% with prazosin and 22% with alfuzosin. The benefits of selfmanagement were apparent at 3 months and were sustained throughout the 12 month trial. TABLE 1 The patients' characteristics at baseline variables was associated with changes in the overall IPSS. However, the analysis did not suggest that the change in IPSS was due purely to changes in the FVC variables. The difference in the mean IPSS between the patient groups decreased only slightly when we took account of mean voided volume, nocturia and total number of voids per 24 h. For example, at 3 months of follow-up, the adjusted difference was 5.4 (95% CI ). Further studies will be required to clarify how a SMP influences voiding characteristics and patient-perceived symptoms. DISCUSSION Previous results have shown that a SMP in addition to standard care significantly improved LUTS compared to standard care alone when measured using the self-rated IPSS. The present results show there were corresponding improvements in some The amount of fluid drunk and voided per 24 h did not alter significantly within and between groups during the follow-up. Thus, subjectively reported improvements in symptoms and the objectively measured changes in voiding characteristics appear not to be due to simple fluid restriction. We used multiple linear regression analysis to assess the degree to which any change in the FVC These results might be biased if there were systematic differences between patients who did and did not complete the FVCs. However, differences in patient characteristics between these groups were shown to be insignificant at baseline, 3, 6 and 12 months of follow-up. Some withdrawals are usual with labourintensive measures like the FVC. The present compliance rate of 69% for completing the 1106 JOURNAL COMPILATION 2009 BJU INTERNATIONAL

4 SELF-MANAGEMENT OF LUTS AND FREQUENCY-VOLUME CHART MEASURES TABLE 2 IPSS and FVC variables at 3, 6 and 12 months Mean (SD) variable SMP Standard care Difference (95% CI) P 3-month outcomes IPSS 10.7 (5.9) 16.4 (5.8) 5.7 ( ) <0.001 Volume voided in 24 h, ml 1619 (629) 1620 (614) 1 ( 239 to 238) 0.99 Mean voided volume, ml 232 (72) 174 (58) 58 (33 83) <0.001 Largest voided volume, ml 411 (130) 368 (170) 43 ( 14 to 100) 0.14 Nocturnal volume, ml 577 (237) 605 (302) 29 ( 132 to 74) 0.58 Fluid intake volume in 24 h, ml 1685 (534) 1725 (636) 41 ( 265 to 184) 0.72 Total number of voids/24 h 7.1 (2.1) 9.7 (3.3) 2.6 ( 3.6 to 1.5) <0.001 Episodes of nocturia/24 h 1.3 (0.8) 2.0 (1.4) 0.7 ( 1.1 to 0.3) <0.001 Episodes of urgency/24 h 1.4 (2.0) 2.1 (2.9) 0.7 ( 1.6 to 0.3) 0.16 Missing values month outcomes IPSS 10.4 (6.1) 16.9 (6.4) 6.5 ( ) <0.001 Volume voided in 24 h, ml 1633 (609) 1631 (601) 3 ( 244 to 250) 0.98 Mean voided volume, ml 228 (72) 182 (56) 46 (20 73) <0.001 Largest voided volume, ml 421 (152) 395 (177) 26 ( 41 93) 0.45 Nocturnal volume, ml 562 (290) 636 (279) 74 ( 191 to 42) 0.21 Fluidintake volume in 24 h, ml 1821 (601) 1818 (586) 3 ( 242 to 248) 0.98 Total number of voids/24 h 7.3 (2.2) 9.0 (2.1) 1.7 ( 2.6 to 0.9) <0.001 Episodes of nocturia/24 h 1.1 (0.8) 1.9 (0.9) 0.8 ( 1.1 to 0.4) <0.001 Episodes of urgency/24 h 1.3 (2.0) 2.1 (2.3) 0.8 ( 1.7 to 0.1) Missing values month outcomes IPSS 10.2 (6.1) 15.4 (6.6) 5.2 ( ) <0.001 Volume voided in 24 h, ml 1637 (579) 1582 (641) 55 ( 238 to 347) 0.71 Mean voided volume, ml 227 (73) 175 (49) 52 (21 83) <0.001 Largest voided volume, ml 435 (169) 353 (125) 82 (9 to 155) 0.03 Nocturnal volume, ml 551 (259) 543 (235) 8 ( 112 to 128) 0.89 Fluid intake volume in 24 h, ml 1698 (422) 1720 (657) 22 ( 281 to 235) 0.86 Total number of voids/24 h 7.4 (2.3) 9.0 (2.6) 1.6 ( 2.8 to 0.5) Episodes of nocturia/24 h 1.0 (0.6) 1.6 (1.2) 0.6 ( 1.0 to 0.2) Episodes of urgency/24 h 1.2 (2.3) 2.0 (2.5) 0.8 ( 2.0 to 0.4) 0.19 Missing values men with LUTS [12] described a decrease in frequency and nocturia and an increase in voided volume, with no significant changes in bladder pressures, on cystometry. Those authors suggested that terazosin had an effect on the fundus of the bladder to increase bladder capacity, and voided volume, and subsequently flow rate. It has now become clear that extraprostatic mechanisms such as stimulation of α1-adrenoceptors in the bladder also play a role in the development of storage symptoms [13 15]. However, whether these pathways are influenced by a SMP is unclear. FVC variables reflecting storage symptoms (frequency, nocturia, urgency) improve with self-management, and whilst this requires further investigation, it might rely on the bladder increasing its capacity, by influencing the sensory component of the bladder. Thus, an effective component of the SMP might be bladder retraining, which has been shown to increase mean voided volumes [6,16]. Fluid management might not have a similar effect, as FVC measures of fluid intake did not differ between control and SMP groups [17]. In conclusion, these results extend our earlier findings by showing that a SMP can influence objective voiding characteristics, and selfreported symptoms. Our study was too small to show how changes in FVC variables are associated with improvements in IPSS. We recommend that further studies are carried out to understand the mechanism through which the SMP works. ACKNOWLEDGEMENTS FVCs was above average compared to other reports of 72-h FVCs collected within this period [8,9]. The effect of a SMP might be due in part to changes in functional bladder capacity, which mirror changes in mean voided volume. Cystometric filling capacity has been shown to be strongly correlated with mean voided volume recorded in FVCs in men with LUTS [10]. Mean voided volume measures have been shown to be relatively stable from both placebo effects and variations in fluid intake [11]. As functional bladder capacity is influenced by detrusor activity and sensory stimuli to the bladder, SMPs might modulate these influences, possibly centrally, resulting in the observed increases in mean voided volume and consequently decreases in frequency and nocturia. However, which particular interventions are most important, and their exact mechanism of action, requires more investigation. It is interesting that the effect of the SMP on FVC variables was similar to the effect of α- blockers. The mechanism of action in LUTS of α-blockers was thought to be relaxation of smooth muscle in the prostate, bladder neck and urethra, thus relieving the dynamic component of obstruction. A previous study on the effect of the α-blocker terazosin in We thank all the men who agreed to take part in this trial. We also acknowledge the work of Jane Coe and Daphne Colpman for acting as facilitators to the self-management groups. The success of this trial was in large part due to their diligence and enthusiasm. We are grateful to the BUPA Foundation for their generous support of this work. CONFLICT OF INTEREST None declared. REFERENCES 1 Brown CT, Yap T, Cromwell DA et al. Self management for men with lower urinary JOURNAL COMPILATION 2009 BJU INTERNATIONAL 1107

5 Y AP ET AL. tract symptoms: randomised controlled trial. BMJ 2007; 334: 25 2 AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol 2003; 170: Madersbacher S, Alivizatos G, Nordling J, Sanz CR, Emberton M, de la Rosette JJ. EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol 2004; 46: Barry MJ, Williford WO, Chang Y et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol 1995; 154: Abrams P, Cardozo L, Fall M et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21: Kim SW, Song SH, Ku JH. Bladder training versus combination of propiverine with bladder training for female urinary frequency. A prospective, randomized, comparative study. Gynecol Obstet Invest 2008; 65: Buzelin JM, Hebert M, Blondin P. Alpha-blocking treatment with alfuzosin in symptomatic benign prostatic hyperplasia: comparative study with prazosin. The PRAZALF Group. Br J Urol 1993; 72: Gisolf KW, van Venrooij GE, Eckhardt MD, Boon TA. Analysis and reliability of data from 24-hour frequency-volume charts in men with lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol 2000; 38: Fitzgerald MP, Brubaker L. Variability of 24-hour voiding diary variables among asymptomatic women. J Urol 2003; 169: van Venrooij GE, Eckhardt MD, Gisolf KW, Boon TA. Data from frequencyvolume charts versus filling cystometric estimated capacities and prevalence of instability in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Neurourol Urodyn 2002; 21: Bryan NP, Chapple CR. Frequency volume charts in the assessment and evaluation of treatment: how should we use them? Eur Urol 2004; 46: Gleason DM, Bottaccini MR. Effect of terazosin on urine storage and voiding in the aging male with prostatism. Neurourol Urodyn 1994; 13: Price D. Potential mechanisms of action of superselective alpha (1)-adrenoceptor antagonists. Eur Urol 2001; 40 (Suppl. 4): Schwinn DA. Novel role for α1- adrenergic receptor subtypes in lower urinary tract symptoms. BJU Int 2000; 86 (Suppl. 2): Andersson KE. Storage and voiding symptoms: pathophysiologic aspects. Urology 2003; 62 (Suppl. 2): Yoon HS, Song HH, Ro YJ. A comparison of effectiveness of bladder training and pelvic muscle exercise on female urinary incontinence. Int J Nurs Stud 2003; 40: Cohen DD, Steinberg JR, Rossignol M, Heaton J, Corcos J. Normal variation and influence of stress, caffeine intake, and sexual activity on uroflowmetry parameters of a middle-aged asymptomatic cohort of volunteer male urologists. Neurourol Urodyn 2002; 21: Correspondence: Tet L. Yap, Clinical Effectiveness Unit, Royal College of Surgeons of England, Lincoln's Inn Fields, London WC2A 3PE, UK. tetyap@gmail.com Abbreviations: SMP, self-management programme; FVC, frequency-volume chart. APPENDIX The main components of the SMP for men with uncomplicated LUTS, recommended by the UK consensus panel [6]. EDUCATION AND REASSURANCE Discuss the causes of LUTS, including normal prostate and bladder function Discuss the natural history of BPH and LUTS, including the expected future symptoms Reassure that no evidence of a detectable prostate cancer has been found FLUID MANAGEMENT Advise a daily fluid intake of ml (minor adjustments made for climate and activity), avoid inadequate or excessive intake on the basis of a frequency/volume chart. Advise fluid restriction when symptoms are most inconvenient, e.g. long journeys or when out in public Advise evening fluid restriction for nocturia (no fluid for 2 h prior to retiring) CAFFEINE AND ALCOHOL Avoid caffeine by substituting with alternatives, e.g. de-caffeinated or caffeinefree drinks Avoid alcohol in the evening if nocturia is bothersome Substitute large volume alcoholic drinks, e.g. pint of beer with small volume alcoholic drinks, e.g. a short CONCURRENT MEDICATION Adjust the time medication with an effect on the urinary system is taken to improve LUTS at times of greatest inconvenience, e.g. long journeys and when out in public Substitute antihypertensive diuretics to suitable alternatives with less urinary effects (via the patient's GP) TYPES OF TOILETING AND BLADDER RE-TRAINING Advise men to double-void Advise urethral milking for men with postmicturition dribble Advise bladder retraining. Using distraction techniques (predetermined mind exercise, perineal pressure or pelvic floor exercises) aim to increase the minimum time between voids to 3 h (daytime) and/or the minimum voided volume to between 200 and 400 ml (daytime). The urge to void should be suppressed for 1 min, then 5 min, then 10 min, etc. increasing on a weekly basis. Use frequency/volume charts to monitor progress MISCELLANEOUS Avoid constipation in men with LUTS 1108 JOURNAL COMPILATION 2009 BJU INTERNATIONAL