Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness

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1 Urological Oncology PELVIC-FLOOR MUSCLE TRAINING AND INCONTINENCE AFTER RP MACDONALD et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness Roderick MacDonald, Howard A. Fink, Chad Huckabay*, Manoj Monga* and Timothy J. Wilt Minneapolis Veterans Affairs Center for Chronic Disease Outcomes Research and the Cochrane Review Group in Prostate Diseases and Urologic Cancers, and *Department of Urology, Veterans Affairs Medical Center, Minneapolis, USA Accepted for publication 25 January 2007 OBJECTIVE To evaluate the effectiveness of pelvic floor muscle training (PFMT) for treating urinary incontinence (UI) after radical prostatectomy (RP) by reviewing evidence from randomized trials. METHODS Randomized trials published in English were included if they involved men with UI after RP and compared PFMT with a control group. Data were abstracted onto a standardized form using a prospectively developed protocol. RESULTS Eleven trials randomizing 1028 men (mean age 64 years) met the inclusion criteria; the duration of the trials was 3 12 months. One trial of 300 men found that those assigned to PFMT achieved continence more quickly (after 1, 3 and 6 months) than men not assigned to PFMT. Men receiving biofeedback-enhanced PFMT were more likely to achieve continence or have no continual leakage than those with no training within 1 2 months after RP (relative benefit increase 1.54; 95% confidence interval ; four trials reporting). The relative benefit increase (1.19, ; five studies) was no longer significant after 3 4 months. Biofeedbackenhanced PFMT was comparable to written/ verbal PFMT instruction. Extracorporeal magnetic innervation (ExMI) and electrical stimulation (ES) were found to be initially (within 1 2 months) more effective than PFMT in one trial, but there were no significant differences between groups at 3 months. CONCLUSION Based on available evidence, PFMT with or without biofeedback enhancement hastens the return to continence more than no PFMT in men with UI after RP. Additional trials are needed to confirm whether ExMI and ES are effective conservative treatment options. KEYWORDS pelvic floor muscle training, urinary incontinence, radical prostatectomy, systematic review INTRODUCTION Radical prostatectomy (RP) is the most common treatment option for prostate cancer, with RPs annually in the USA [1]. Urinary incontinence (UI) is a common and costly complication in men after RP, often adversely affecting their quality of life [2,3]. The direct economic burden for UI from any cause in men is estimated to be US$ 3.8 billion/year. Patients bear a significant proportion of the direct costs of UI, including the costs of pads, catheters and clamps, as well as lost productivity in the workforce for patients and family members [4]. Despite improvements in surgical techniques and a better understanding of pelvic anatomy, survey studies indicate that 8 56% of men report UI at 1 year after RP [5 7]. The cause of UI after RP is not completely understood, but leakage is thought to result primarily from sphincteric insufficiency, resulting from sphincteric injury or detrusor overactivity and effects on the bladder detrusor muscle [8,9]. Pelvic floor muscle training (PFMT) is a first-line treatment used to restore pelvic floor or bladder function after RP. PFMT trains subjects to isolate and correctly contract the PFMs to increase strength and endurance. Repeated contractions are thought to improve urinary control through increased support for the detrusor muscle and urethral sphincter [10]. Biofeedback can be used as a learning tool to assist subjects on how to contract the PFMs, using visual or auditory feedback through the use of electrical external or internal devices, or verbal feedback from a therapist when a contraction is noted during a DRE. Thus, we systematically reviewed evidence from randomized trials to evaluate PFMT for UI after RP. METHODS A Medline search, from 1966 to July 2006, combined an optimally sensitive Cochrane Collaboration search strategy [11]. In addition, the Cochrane Library and the Cochrane Urinary Incontinence Review Group specialized registry, and reference lists of identified trials and reviews, were searched. Studies were restricted to those written in English BJU INTERNATIONAL 100, doi: /j x x

2 PELVIC-FLOOR MUSCLE TRAINING AND INCONTINENCE AFTER RP Studies were included: if they enrolled men with UI after RP or TURP; reported clinical outcomes (e.g. number returning to continence, based on questionnaire or voiding dairy, leakage episodes, pad tests); randomly assigned participants to treatment or control (usual care/no treatment, placebo, or active control); and were published in English. Study and demographic characteristics, enrolment criteria, efficacy outcomes, quality of life data, adverse effects, number and reasons for withdrawal were then extracted. The quality of concealment of treatment allocation for randomization was determined based on the scale developed by Schulz et al. [12]. We assessed whether subjects, investigators or outcome assessors were unaware of the treatment assignments, if the analysis was by intention-to-treat, and the percentage lost to follow-up or withdrawn from the study protocol. If applicable, efficacy data were pooled and analysed in Cochrane Collaboration Review Manager (RevMan 4.2) software [13]. Relative risk reductions and their 95% CI were calculated for categorical outcomes. The DerSimonian and Laird random-effects model was used if there was evidence of heterogeneity between the studies, based on the chi-square test for heterogeneity and the I 2 test [14,15]. RESULTS Eleven trials met inclusion criteria (Table 1) [16 26]; eight evaluated PFMT enhanced with biofeedback [17 24], of which six were compared to no training/usual care or placebo [17 21]. Three compared biofeedbackenhanced (BE) PFMT with verbal/written instruction on PFMT [22 24], and one trial compared PFMT with or without electrical stimulation (ES) to verbal/written instruction on PFMT [25]. One three-armed trial compared PFMT with extracorporeal magnetic innervation (ExMI) and ES [26]. Three trials randomized subjects and initiated therapy before RP [17,18,24]. Four trials reported some study blinding, typically having investigators or outcome assessors unaware of group assignments [17,19,24,25]. The quality of concealment of treatment allocation for randomization was adequate in two trials [23,25], and analysis by intention-to-treat was used in six [17 19,23,25,26]. The study duration was generally 6 or 12 months. Continence was measured subjectively, either using a questionnaire or voiding diaries, or objectively by pad tests. Due to variations in treatments, measured clinical outcomes, participant characteristics and study design, quantitative pooling measures were not used for all studies. The demographic and baseline characteristics of participants are shown in Table 1. Within the 11 trials, 1028 men (mean age 64 years) were randomized; 4% withdrew before trial completion. Most men had localized prostate cancer, although two studies noted men with advanced disease [19,22]. The efficacy outcomes are listed in Table 2; for PFMT with no biofeedback vs no training, one trial of 300 men found that PFMT significantly reduced the time to recover continence [16]. There was an improvement at 1, 3 and 6 months after RP compared with no PFMT. After 12 months, 1% in the PFMT group was using two or more pads daily, compared to 12% in the control group. Six (4%) PFMT and four (3%) men with no training developed symptomatic anastomotic stricture requiring endoscopic treatment. Five trials enrolling 348 men assessed BE- PFMT after RP vs no training or usual care [17 21]. In the pooled analysis significantly more men in the BE-PFMT group achieved continence or were without continual leakage than in the no-training group at 1 2 months after RP, at 57% vs 37% (relative benefit increase 1.54; 95% CI ; four trials) [17,18,21,22]. All five studies provided data for 3 4 months after RP; the pooled analysis showed the relative benefit increase was no longer significant (1.19; ), with 87% and 69% of the men in the PFMT and notreatment groups achieving continence, respectively. In the largest trial using preoperative training, there were significantly fewer men in the PFMT group wearing pads at 6 months after RP than in the no-training group, at 32% vs 52%, respectively [17]. There was a mean of 73 days without leakage in the PFMT group and 54 days in the no-training group (P < 0.05). Biofeedback-enhanced PFMT was compared to written/verbal PFMT instruction in three trials of 281 men [22 24]. No study reported a significant difference between treatments for any outcome at any of the evaluated times, and other treatments were effective in returning men to continence compared to baseline. Starting BE-PFMT before RP had no effect on improving the UI outcome compared with PFMT after RP [24]. One trial of 63 men with UI at 8 weeks after RP found PFMT combined with ES was no more effective in reducing leakage than PFMT with a physiotherapist or than PFMT with verbal and written instruction only [25]. Compared to the baseline before treatment, all groups effectively reduced their urine loss, as measured by pad tests after 12 weeks of treatment. Therapy with ES and ExMI significantly reduced leakage within the first 2 months compared with PFMT in a trial of 36 men. There were no significant differences among any of the treatment groups at either 3 or 6 months, and no complications were reported for any of the groups. DISCUSSION This review represents a broad overview of randomized controlled studies of PFMT for UI after RP; most of the studies were of first-line conservative strategies, mainly PFMT. The results show that PFMT with no BE was better than no PFMT in hastening the return to continence. Men treated with BE-PFMT also returned to continence more quickly, within 1 2 months after RP, than men with no PFMT. Within 3 4 months there were no significant differences in the rates of continence between groups. Biofeedback-enhanced PFMT was no more effective than oral or written PFMT instruction. While the evidence indicates support for PFMT, usage is limited and cannot be applied to every patient after RP. Men need to be motivated and have their pelvic floor neurologically intact. More passive interventions such as ES and ExMI initially improved UI more quickly than PFMT, within 1 2 months, but this finding was based on one small study from Japan, and it is uncertain if ExMI is available or in use in the USA [26]. Further trials are needed to confirm the efficacy and to determine if ES and possibly ExMI are appropriate treatment options for men unable to use PFMT. The pooled results of the BE-PFMT trials should be interpreted cautiously. Results from only two studies were statistically significant and the pooled benefit is based primarily on 2007 BJU INTERNATIONAL 77

3 MACDONALD ET AL. TABLE 1 A description of the studies Reference Interventions and {study duration} PFMT with no BE vs no PFMT Filocamo et al. [16] PFMT instruction after catheter removal (n = 150). No PFMT instruction (n = 150). {12 months after RP} BE-PFMT vs no PFMT or placebo Burgio et al. [17] Biofeedback-enhanced PFMT instruction (n = 63). Usual care (n = 62). {6 months after RP} BE-PFMT instruction before RP Parekh et al. [18] Biofeedback-enhanced PFMT before and after RP (n = 19). No formal education on PFMT (n = 19). {12 months after catheter removal} Van Kampen et al. [19] Biofeedback-enhanced PFMT (n = 50). 7 who could not or weakly contract PFMs given ES. Placebo ES (n = 52). {12 months after catheter removal} Franke et al. [20] Biofeedback-enhanced PFMT (n unclear, results available for 13, 13, and 7 men at 6, 12 and 26 weeks). Voiding diary only (n unclear, results available for 11, 10, and 8 men at 6, 12 and 26 weeks). {6 months after RP} Mathewson-Chapman [21] Biofeedback-enhanced PFMT (n = 27). No PFMT instruction (n = 24). {3 months after RP} BE-PFMT vs verbal/written instruction on PFMT Wille et al. [22] Biofeedback-enhanced and ES-PFMT (n = 46). ES-enhanced PFMT (n = 46). Verbal + written instruction on PFMT only (n = 47). {12 months after RP} Floratas et al. [23] Biofeedback-enhanced PFMT (n = 28). Verbal instruction on PFMT only (n = 14). {6 months after catheter removal and start of treatment} Bales et al. [24] Biofeedback-enhanced PFMT before RP (n = 50) 2 4 weeks before RP, 45-min session with nurse trained in biofeedback. {6 months after RP} Written and brief verbal instructions on PFMT (n = 50). Both groups encouraged to use PFMT 4 /day after catheter removal 2 weeks after RP. PFMT with/with no ES vs verbal/written instruction on PFMT Moore et al. [25] Intensive PFMT (n = 18). PFMT alternating with ES (n = 19). Written + brief verbal instructions on PFMT (n = 21). {6 months after study enrolment} ES vs ExMI vs verbal/written instruction on PFMT Yokoyama et al. [26] Functional PF ES (n = 12). ExMI (n = 12). Verbal instruction on PFMT only (n = 12). {6 months after catheter removal} Description of men, inclusion criteria (withdrawals/ lost to follow-up) 300 Italian, mean age 66 (45 75), after RRP. Nerve-sparing 61%. (two from control group at 12 months). 125 American, mean age 60.9 (SD 6.9), after RP for LPC. 28% Black. Men had to be ambulatory and continent before RP. (ITT 57 treatment and 55 control; 51 for both assessed at final follow-up). 38 consecutive American men having RRP for LPC, mean age treatment group 62, 55.5 for control group (P < 0.02). (One from each group). 102 consecutive Belgian, mean age 65.5, after RRP for clinically LPC and had UI 15 days after removal of catheter. (two from each group). 30 American, mean age 61.5, after RRP with PVR of <50 ml. (Five in all after initial randomization). 53 American, mean age 62 (47 75), after RP for LPC. None had UI before RP (two men unaccounted for). 139 German, mean age 65, after RRP for clinically LPC. (10 unavailable at last follow-up questionnaire. Data on pad test for 124 men). 42 consecutive European, mean age 64, after RRP for LPC. Objectively confirmed UI; no significant complications and no history of UI before RP. (None). 100 consecutive American, mean age 60 after RRP for clinically LPC. (3 in the BE-PFMT group). 63 Canadian, mean age 67 (49 77), after RRP, with UI 8 weeks after. All White; (Two from PFMT and three from PFMT/ES group). 36 Japanese, mean age 67, after RRP. (None reported) RRP, retropubic RP BJU INTERNATIONAL

4 PELVIC-FLOOR MUSCLE TRAINING AND INCONTINENCE AFTER RP TABLE 2 Treatment comparisons of the return to continence or reduction in urinary leakage Study PFMT with no BE vs no PFMT Filocamo et al. [16] Efficacy outcome % (n) achieving continence: completely dry or occasional leakage, measured subjectively by questionnaire and objectively by 1-h and 24-h pad test ( 1 precautionary pad denoted continence) Sample time, months Control 8 (12/150) 30 (45/150) 65 (97/150) 88 (130/148) PFMT 19 (29/150) 74 (111/150) 96 (144/150) 99 (148/150) P between groups <0.001 <0.001 NR BE-PFMT vs no PFMT or placebo Burgio et al. [17] % (n) with severe or continual leakage: continence defined as three consecutive weekly 1-day dairies showing no leakage or a completed 7-day diary with no leakage Sample time, months Control 40 (19/48) 25 (12/49) 20 (10/51) BE-PFMT 27 (14/52) 8 (4/49) 6 (3/51) P between groups Parekh et al. [18] % (n) achieving continence: defined by 0 or 1 pad/day Sample time, months and 7 12 Control 21 (4/19) 37 (7/19) 53 (10/19) 63 (12/19) 79 (15/19) BE-PFMT 37 (7/19) 68 (13/19) 79 (15/19) 79 (15/19) 84 (16/19) Van Kampen et al. [19] % (n) achieving continence: defined by urine loss <2 g (both the 1-h and 24-h pad test) and when men indicated they had not been incontinent the previous 3 days) Sample time, months (10/52) 39 (20/52) 56 (29/52) 77 (40/52) 81 (38/47) 50 (25/50) 74 (37/50) 90 (43/48) 95 (41/43) 95 (41/43) P between groups NR NR NR NR Franke et al. [20] n/n of men achieving continence: defined as being pad-free Sample time, months 3 6 Control 7/10 7/8 BE + PFMT 7/13 1/7 Mathewson-Chapman [21] n (%) achieving continence based on time to achievement: defined as being pad free Sample time, days Control 13 (3/24) 17 (4/24) 8 (2/24) 21 (5/24) 15 (10/24) BE + PFMT 15 (4/27) 15 (4/27) 27 (7/26) 15 (4/27) 27 (7/26) BE-PFMT vs verbal/written instruction on PFMT Wille et al. [22] % achieving continence at 12 months: measured by a 20-min pad test PFMT 77 BE-PFMT 91 Electrical Stimulation (ES) enhanced PFMT % achieving continence according to questionnaire: Sample time, months 3 12 PFMT BE + ES + PFMT ES-PFMT P between groups Overall, 21.4% were continent according to questionnaire immediately after catheter removal Floratas et al. [23] Mean number of pads per day: continence defined by 0 or 1 pad/day Sample time, months PFMT BE-PFMT P between groups >0.05 Mean urine loss, g/1-h pad test: continence defined as urine loss <1 g/1-h PFMT BE-PFMT P between groups >0.05 Bales et al. [24] % (n) achieving continence: defined by 0 or 1 pad/daily 2007 BJU INTERNATIONAL 79

5 MACDONALD ET AL. TABLE 2 Continued Study Efficacy outcome Sample time, months PFMT 24 (12/50) 62 (31/50) 48/50 BE-PFMT 19 (9/47) 57 (27/47) 44/47 P between groups NS NS NS PFMT with/with no ES vs verbal/written instruction on PFMT Moore et al. [25] Mean (SD) urine loss, g/24-h pad test: continence defined by urine loss <2 g/24 h; <10 g considered socially acceptable Sample time, months PFMT (395.5) (23.8) 67.3 (11.5) 54.1 Intensive PFMT (513.9) 86.9 (32.5) 73.5 (10.4) 69.9 ES-PFMT (492.1) (87.5) (85.7) 98.2 P between groups NS NS NS NS By 6 month 48% (28/58) had urine loss < 10 g. ES vs ExMI vs verbal/written instruction on PFMT Yokoyama et al. [26] n/n free of pads at 6 months PFMT 10/12 ES 10/12 ExMI 11/12 Mean urine loss, g/24-h pad test Sample time, months PFMT <10 for all groups ES ExMI P between groups vs PFMT vs PFMT NS one trial [19]. Treatment regimens were not standardized and the studies varied in the type of biofeedback used, duration and intensity of training, and when training was initiated (before or after RP), and outcome measurements. There was insufficient data to evaluate the effectiveness based on surgical approach (i.e. radical retropubic, radical perineal, laparoscopic). These factors limit the assessment of the overall effectiveness of PFMT. All these variables, and the degree of UI (mild, moderate, or severe), could lead to substantial clinical differences. Given the substantial impact of UI after RP on quality of life, further randomized studies should evaluate therapies for subjects refractory to conservative strategies solely in this population. This systematic review is limited by the quality of the studies assessed; most were of uncertain quality, noted by the lack of description of randomization concealment and blinding techniques. Concealment of treatment allocation for randomization was adequate for only two of the trials [17,25]. Although ensuring that the subjects were unaware of treatment was not feasible, ensuring that investigators of outcome assessment were unaware was reported in four trials [17,19,24,25]. Analysis by intention-to-treat was not evident in several trials or was not indicated. The mean age of the treatment group was significantly greater than the control group in one trial [18]. Results might have been biased when men lost to follow-up were unaccounted for. Results for only half of the men randomized in the trial by Franke et al. [20] were presented at the final assessment. Only one trial noted that subjects with no results were categorized as incontinent [18], and only two trials reported on adverse effects occurring during the study [16,26]. PFMT, with or without BE, appears to hasten the return to continence more quickly than no PFMT training in men after RP. The overall effectiveness is difficult to assess, given the variability among treatment regimens. ExMI and ES might be effective conservative treatment options, but additional studies are needed to confirm their efficacy. Further studies should evaluate therapies for men with chronic UI refractory to conservative strategies, and whether PFMT before RP helps prevent UI after RP. ACKNOWLEDGEMENTS The authors acknowledge Indulis Rutks for his work on the literature search and article retrieval. This project was supported by NIDDK R01 DK A2 the Department of Veterans Affairs Health Services Research and Development Service and the Minneapolis VA Center for Chronic Disease Outcomes Research. The views expressed in this article are those of the author(s) and do not necessarily represent the views of the Department of Veterans Affairs. CONFLICT OF INTEREST None declared. REFERENCES 1 United States Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project (USA). Available at: Accessed February Litwin MS, Hays RD, Fink A et al. Quality-of-life outcomes in men treated for localized prostate cancer. JAMA 1995; 273: BJU INTERNATIONAL

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