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Recovery of Urinary Continence After Radical Prostatectomy Using Early vs Late Pelvic Floor Electrical Stimulation and Biofeedback-associated Treatment
Oncology Recovery of Urinary Continence After Radical Prostatectomy Using Early vs Late Pelvic Floor Electrical Stimulation and Biofeedback-associated Treatment Gianna Mariotti, Stefano Salciccia, Michele Innocenzi, Alessandro Gentilucci, Andrea Fasulo, Vincenzo Gentile, and Alessandro Sciarra OBJECTIVE MATERIALS AND METHODS
RESULTS
CONCLUSION
To compare the early vs late use of pelvic floor electrical stimulation (FES) plus biofeedback (BF) in terms of time to recovery and rate of continence after radical prostatectomy (RP). Between April 2007 and April 2012, a total of 120 patients who underwent RP were prospectively included in the study. In group 1 (60 cases), we included patients who presented a urinary leakage weight 50 g for 24 hours, 14 days after catheter removal. In group 2 (60 cases), we included patients who continued to present a urinary leakage weight 50 g for 24 hours, 12 months after surgery. In both groups, patients were prospectively submitted to the same program of BFþFES. Mean leakage weight became significantly lower (P <.002) in group 1 than in group 2 starting from visit 1 (2 weeks) through visit 7 (24 weeks). However, a significant difference (P <.05) between the 2 groups in terms of percentage of continent patients was achieved only at 2 weeks (group 1 ¼ 20%; group 2 ¼ 0%) and 4 weeks (group 1 ¼ 66.7%; group 2 ¼ 46.7%). The objective continence rate 6 months after the beginning of treatment was 96.7% in group 1 and 91.7% in group 2. In our experience, the treatment with BF and FES has a significant positive effect on the recovery of urinary continence independently to the time in which it is used (early vs delayed). This protocol might represent a noninvasive method for all patients undergoing RP, also in a 12month interval from surgery. UROLOGY 86: 115e121, 2015. 2015 Elsevier Inc.
D
espite relevant improvements in the surgical technique, radical prostatectomy (RP) remains one of the most important causes of iatrogenic incontinence in men. Reported prevalence rates of urinary incontinence (UI) after RP vary from 5% to >60% according to both the criteria used to define incontinence and the postoperative time of assessment.1,2 The prevalence and severity of UI decreases with postoperative time: 8%-87% of patients have UI at 6 months postoperatively and 5%-44% at 12 months postoperatively.3,4 The etiology of post-RP UI is not completely understood, but it primarily results from sphincter insufficiency, detrusor overactivity, reduced bladder compliance, and
Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, Policlinico Umberto I, Rome, Italy; the Department of Urology, University Sapienza, Rome, Italy; the Prostate Unit, Department of Urology, Policlinico Umberto I, University Sapienza, Rome, Italy; and the Italian National Statistical Institute, Rome, Italy Address correspondence to: Alessandro Sciarra, M.D., Prostate Unit, Department of Urology, Policlinico Umberto I, University Sapienza, Viale Policlinico, Rome 155 00161, Italy. E-mail: [email protected] Submitted: January 17, 2015, accepted (with revisions): February 27, 2015
ª 2015 Elsevier Inc. All Rights Reserved
decreased contractility.5,6 Prognostic factors for post-RP UI include age, previous bladder surgery, nerve-sparing status, anastomotic stricture, and surgical experience.7,8 Various noninvasive treatments have been analyzed.9,10 Pelvic floor muscle training (PFMT) is the most widely used noninvasive method of increasing pelvic floor muscle strength.11,12 However, it can take several months to restore continence and some patients have persistent incontinence despite treatment.5 In a previous study13 on cases submitted to RP, we compared the benefit of the early combined use of functional pelvic floor electrical stimulation (FES) and biofeedback (BF) with PFMT. Our analysis showed that the early (7 days after catheter removal) noninvasive treatment with FESþBF has a significant positive effect on the early recovery of urinary continence (at 4 weeks 63% continent with FESþBF vs 30% with PFMT) after surgery, also maintained in the long term (at 6 months 96.7% continent with FESþBF vs 66.7% with PFMT). Post-RP UI has a significant negative effect on postoperative health-related quality of life. Therefore, conservative treatments with a potential to reduce early UI http://dx.doi.org/10.1016/j.urology.2015.02.064 0090-4295/15
115
Table 1. Patient characteristics at baseline Characteristic Number of patients Age (y), mean SD; median and range Preoperative PSA (ng/mL), mean SD; median and range Pathologic stage, n pT2N0 pT3No Pathologic Gleason score, n 7 (3þ4) or less 7 (4þ3) or greater Surgical technique RP, n Laparoscopic Open Nerve-sparing procedure, % Yes (unilateral or bilateral) No Postoperative PSA (ng/mL), mean SD; median and range Catheter removal (d) Leakage wt/24 h (g), mean SD; median and range Prostate volume (cm3), mean SD; median and range
Group 1 60 59.61 4.03 (60); 50-67 6.95 2.40 (7.5); 3.5-12.0
Group 2 60 59.28 4.19 (60); 50-67 6.97 2.32 (7.7); 3.0-12.0
P Value(2-Tailed t Test) — >.05 >.05
54 6
55 5
>.05
48 12
46 14
>.05
20 40
22 38
>.05
42 18 0.05 0.03 (0.05); 0.01-0.1 14 295.0 141.03 (300); 50-700 46.91 8.44 (45); 35-70
44 16 0.04 0.02 (0.04); 0.01-0.1 14 322.5 135.11 (300); 50-700 49.41 7.65 (50); 35-70
>.05 >.05 — >.05 >.05
PSA, prostate-specific antigen; RP, radical prostatectomy; SD, standard deviation.
are of relevant clinical interest. However, in the clinical practice, not always it is possible or the patient accepts an early physical treatment for UI, and a percentage of cases are managed only with verbal indications for exercises. In cases with persistent UI after several months from RP, the choice of noninvasive procedures such as FES or BF could remain valid. We tried to evaluate whether the positive results on post-RP UI obtained with the combination of FESþBF in the early interval from surgery (<1 months) can be maintained also in cases with persistent UI after a long interval (12 months) from RP. The aim of this prospective study was to analyze and to compare the early vs late use of FESþBF as a learning tool for pelvic floor muscle exercises in terms of time to recovery and rate of continence after RP.
MATERIALS AND METHODS Population Between April 2007 and April 2012, a total of 120 patients who underwent RP at our institution for clinically localized prostate cancer were included in the study. Patient characteristics are described in Table 1. Exclusion criteria were prior bladder or prostate surgery, prior urinary or fecal incontinence, neurogenic dysfunction, preoperative history of overactive bladder, and psychiatric history or significant perioperative complications. None of these patients received radiotherapy after RP. No patient was prescribed anticholinergic drugs (or other drugs able to influence urinary continence) during the study. Patients were divided into 2 groups. In group 1 (60 cases), we included patients submitted to RP who presented a urinary leakage weight 50 g for 24 hours, 14 days after catheter removal. All cases were considered for an early treatment that began 14 days after catheter removal. 116
In group 2 (60 cases), we included cases submitted to RP who continued to present a urinary leakage weight 50 g for 24 hours, 12 months after surgery. During this year, cases received only usual instructions to conduct pelvic muscle exercises (PME), which included verbal instruction (how to correctly and selectively contract the anal sphincter while relaxing the abdominal muscles) by the urologist and written examples of exercises (Kegel exercises).
Treatment Patients were enrolled in a prospective analysis in both groups (1 and 2). All cases signed an informed consent before treatment and the protocol was approved by our internal ethical committee. In both groups, patients were submitted to the same program of BFþFES performed by the same clinician (G.M.). In group 1, the program started 14 days after catheter removal (early program), whereas in group 2, 12 months after surgery (late program). The BFþFES program was described in a previous article.13 Patients met the clinician twice a week for 6 weeks. Each of the 12 treatment sessions was homogeneously composed of a first part with BF (15 minutes) followed by a second part with FES (20 minutes). Thus, each session lasted 35 minutes. Patients were placed in a supine decubital position. For FES, a surface electrode was inserted into the anus and pulsed at 30 Hz (first 10 minutes) and 50 Hz (second 10 minutes) square waves at a 300-ms pulse duration and a maximal output current of 24 mA. The intensity was adequate to induce visual lifting of the levator ani and pubococcygeus muscle, considering the level of comfort of the patient.14 For BF, a 2channel electromyographic BF apparatus (Reactive Biofeedback; BEAC, Stradella, Italy) was used, with 1 channel for perineal and the other for abdominal muscle and the signal received through surface electrodes.10 During the initial 2-3 sessions, a strong emphasis was placed on the specificity of muscle contraction (contraction of pelvic muscles with UROLOGY 86 (1), 2015
Figure 1. Mean leakage weight variation in the 2 groups at different intervals of follow-up. (Color version available online.) minimum activity of abdominal muscles). During the following sessions, the exercises were designed to increase the power and endurance of the pelvic floor muscles. Verbal guidance of the contractions was also used to instruct the patient how to correctly continue the exercises at home. Initially, the patients performed these exercises while supine but later also when sitting or standing during normal daily activity.
Outcomes Assessment In both groups (1 and 2), the evaluation was performed at time 0 (before treatment beginning and 14 days after catheter removal in group 1 and 12 months after surgery in group 2), during follow-up at 2 and 4 weeks and 2, 3, 4, 5, and 6 months. UI was objectively assessed using the 24-hour pad test and the number of pads used (primary outcome). Objective continence was defined as no pad use (pad weight gain during the test of 2 g or less).14 Subjective evaluation (secondary outcome) was made using the incontinence section of the International Continence Society (ICS)-male questionnaire.15 Moreover, patients were asked to keep a voiding diary including the number of incontinence episodes, the number and volume of voids, and the number of pads used. Because urodynamic studies are invasive, they were avoided and used only in cases with UI after the 6month follow-up (according to ICS standards).16 At 12month interval, the percentage of continent (no pad use) cases was also reported.
Statistical Analysis The study was designed to have an 80% power to detect a difference in improvement rates for a 2-tailed test with 5% type UROLOGY 86 (1), 2015
I error. A 2-tailed t test with 5% type I error was used to compare variables between the 2 groups. A Welch 2-sample t test was used to verify differences in the proportion of patients in the 2 groups who were continent at various follow-up intervals. Univariate and multivariate stepwise regression analysis of the risk factors for incontinence (age, prostate volume, stage, and surgical technique) was performed. A P value <.05 was considered statistically significant. An R 3.1.1 statistical software was used.
RESULTS A total of 120 cases were included in the evaluation. At time 0, no significant differences between group 1 (early treatment) and group 2 (late treatment) were present (Table 1). All patients were evaluable for the entire follow-up and all completed the BFþFES program. No complications were found in any patient and no cases complained of discomfort or irritation from the probe. At time 0, the mean leakage weight for 24 hours was 295.0 141.03 g in group 1 and 322.5 135.11 g in group 2 (P ¼ .2776; Table 1). Mean leakage weight became significantly lower (P < .002) in group 1 than in group 2 starting from visit 1 (2 weeks) through visit 7 (24 weeks; Fig. 1; Table 2). In both groups (1 and 2), a significant (P < .05) reduction in mean leakage weight compared with time 0 was observed from visit 1 (2 weeks) through visit 7 (24 weeks). A significant difference (P < .05) between the 2 groups in terms of percentage of continent patients was achieved 117
Table 2. Mean leakage weight in grams at the different intervals Time Intervals
Group 1, Mean SD; Median (range)
Group 2, Mean SD; Median (range)
P Value
Time 0 Visit 1 (2 wk) Visit 2 (4 wk) Visit 3 (8 wk) Visit 4 (12 wk) Visit 5 (16 wk) Visit 6 (20 wk) Visit 7 (24 wk)
295.0 141.03; 300.0 (50.0-700.0) 153.83 108.22; 100.0 (0-500.0) 84.83 96.48; 50.0 (0-400.0) 52.48 74.77; 30.0 (0-400.0) 29.65 59.60; 0 (0-300.0) 16.65 37.76; 0 (0-200.0) 10.48 30.66; 0 (0-200.0) 6.98 20.10; 0 (0-100.0)
322.50 135.11; 300.0 (50.0-700.0) 217.50 102.02; 200.0 (50.0-500.0) 133.0 105.53; 100 (0-400.0) 92.0 75.95; 50 (0-300.0) 65.16 54.38; 50 (0-200.0) 49.0 44.02; 50 (0-200.0) 37.33 32.30; 40 (0-150.0) 28.16 30.55; 30 (0-100.0)
.2776 .0012 .0102 .0048 .0008 <.0001 <.0001 <.0001
Abbreviations as in Table 1.
Figure 2. Percent of continent patients in the 2 groups at different intervals of follow-up. (Color version available online.)
only at 2 weeks (group 1 ¼ 20%; group 2 ¼ 0%) and 4 weeks (group 1 ¼ 66.7%; group 2 ¼ 46.7%; Fig. 2; Supplementary Tables 1 and 2). In all other intervals, although the percentage of continent cases was always higher in group 1 than in group 2, differences did not reach significance (P > .05). Results on ICS-male questionnaire on incontinence at the different intervals are described in Supplementary Table 2. In both groups, only prostate volume was significantly and independently associated with the time of continence achievement (univariate and multivariate regression analysis; P ¼ .0001) (Supplementary Table 3). In particular, prostate volume was higher and times to continence recovery using BFþFES treatment were longer. At the end of the follow-up (6 months), 3.3% (2 patients) in group 1 and 8.3% (5 patients) in group 2 118
remained incontinent (1, urine loss >2 g). Therefore, the objective continence rate 6 months after the beginning of treatment was 96.7% in group 1 and 91.7% in group 2. All incontinent cases at visit 7 underwent urodynamic evaluation that showed sphincter deficiency in 1 of 2 in group 1 and 3 of 5 in group 2 and detrusor overactivity in 1 of 2 in group 1 and 2 of 5 in group 2. After 1 year in both groups the same percentage of cases reported at 6 months (group 1 ¼ 96.7%; group 2 ¼ 91.7%) maintained continence.
COMMENT UI after RP is mainly determined by a sphincter deficiency caused by anatomic and functional changes during surgery.5,6 As a noninvasive treatment, behavioral UROLOGY 86 (1), 2015
training using PFMT seems to be a logical approach. Kegel first proposed PFMT to improve urinary control, and various studies analyzed its role in post-RP UI.3,9,17,18 Filocamo et al9 analyzed 300 cases treated with RP randomly assigned to early PFMT (at catheter removal) vs control. A significantly (P <.001) greater percentage of patients in the treated group vs controls achieved continence after 6 months (94.6% vs 65.0%). Patel et al3 retrospectively analyzed 284 men undergoing RP. The intervention group received physiotherapist-guided PFMT, whereas the control group was provided with verbal instruction on exercises by the surgeon alone. At 6 weeks after operation, the 24-h pad weight was significantly lower (9 g vs 17 g; P <.01) for the intervention group. Geraerts et al18 randomly analyzed 180 men who underwent RP (open and laparoscopic); patients treated with additional preoperative PFMT had no shorter duration of postoperative UI compared with only postoperative PFMT (P ¼ .878). Floratos et al10 found similar (91%) objective continence rates at 6 months after RP using electromyographic BF or verbal instruction for PFMT. On the contrary, Ribeiro et al19 on 73 patients submitted to RP reported that early BF not only hastens the recovery of urinary continence after surgery but allows for significant improvements in the severity of incontinence. Furthermore, FES has been described as a conservative treatment of UI after RP. Moore et al14 compared the advantageous effect of the association of FES and PFMT to PFMT alone in terms of post-RP UI. They started treatment only after 8 or more weeks from surgery. After only 12 weeks of analysis, they demonstrated no significant (P >.05) differences in overall urine loss between the 2 groups. Yamanishi et al5 analyzed 56 men with severe UI after RP. In the group treated with FESþPFMT, a significantly higher percentage (P <.05) of continent patients when compared to the group treated with PFMT alone was observed from 1 month to 6 months of follow-up (81% vs 44% at 6 months). In a previous study,13 we analyzed the advantageous effect of the early combined use of BF and FES on the early recovery of UI after RP. Sixty cases were prospectively randomized to a treatment group with FES and BF starting 7 days after catheter removal vs a control group with verbal instructions for PFMT. The mean leakage weight became significantly lower (P <.05) in the active group than in the control group starting at 4 weeks until 6 months of follow-up. A significant difference (P <.05) between the 2 groups in terms of percentage of continent patients was achieved from 4 weeks (63% vs 30%) to 6 months (96% vs 66%). Most of the studies in the literature showed that an early noninvasive treatment of post-RP UI is feasible and significantly improves continence rate and time to recovery. However, in the clinical practice, not always it is possible or the patient accepts an early physical treatment for UI and a significant percentage of cases UROLOGY 86 (1), 2015
are managed only with verbal instructions for exercises. In cases with persistent UI after several months from RP, the choice of noninvasive procedures such as FES or BF could remain valid. We tried to evaluate whether the positive results on post-RP UI obtained with the combination of FESþBF in the early interval from surgery (<1 months) can be maintained also in cases with persistent UI after a long interval (12 months) from RP. The significance of our study is based on the prospective analysis, on the homogeneous characteristics of the 2 groups, and on the objective evaluation of outcome assessment. In particular, all patients underwent standard RP (open or laparoscopic), and in all cases, the catheter was removed after a similar interval. Patients were considered continent only when no pads were required and the weight gain of the pad during the test was 2 g. A more objective evaluation of UI would be a urodynamic study. However, these investigations are invasive, especially soon after surgery. Thus in our study, as previously reported, urodynamics were postponed and used only in refractory cases after 6 months.9,13 Limitations of our study included no measurement of urinary control results in terms of improved quality of life and costs of health care. Moreover, a control untreated group was not included, and this aspect produces an only hypothesis-generating analysis. Treatment was homogeneously performed in all cases of both groups for 12 sessions. BF and FES were performed in each session. The rationale for placing BF and FES in the same session is to perform 3 consecutive steps in each session (1) to emphasize the specificity of muscle contraction (BF), (2) to increase the power and endurance of pelvic floor muscles (BF), and (3) to artificially stimulate and increase the periurethral striated muscle (FES).13 This type of session also helps patients to better perform and continue exercises at home. If muscles work efficiently (BFþFES), it is easier for the patient to create an autonomic pelvic floor contraction to prevent stress events.13 Fatigue of the periurethral striated muscles is often the cause of increased urine loss during the second part of the day and this can be prevented by BFþFES sessions.13 It is not possible to estimate the exact contribution of each method to the final results, but BF and FES work together in this setup. In the present analysis, we did not use a control group as in the first study,13 but we compared the same treatment (BFþFES) at different intervals from surgery (early vs late). The benefit of this physical treatment using the combination of BF and FES is particularly evident in the early recovery of continence and in the reduction of urine leakage, already at 2 weeks from the beginning. Afterward, benefits are maintained also at treatment end till the 6-month control. Compared with other protocols reported in the literature,3,5,9,10 our combined treatment produced a high percentage of continent patients (>90%). It is also important to emphasize the safety of this protocol. It is not harmful, has a complete 119
compliance, and does not compromise future treatment options. In the early treatment group (group 1), we confirmed the positive results described in our previous study.13 During the follow-up, mean leakage weight was always significantly lower in the early vs the late treatment group. However, only at 2- and 4-week intervals the percentage of continent cases was significantly higher in the early vs the late treatment group. The initiation of the treatment program soon after surgery, when patients have not become accustomed to the idea of wearing a pad, contributes to these significant results and might explain the complete compliance. However, the results and the fact that >90% of cases reached continence at 6-months follow-up in the late treatment group encourage the use of our program also in cases with a persistent leakage 1 year after surgery. Palisaar et al20 evaluated 22 clinical and oncologic variables to determine whether they were associated with early urinary continence status after physical treatment for post-RP UI. At the univariate analysis, age, clinical stage, prostate-specific antigen level, prior prostate surgery, Gleason score, nerve-sparing status, and catheter time were significant predictors (P < .05). On multivariate analysis, nerve-sparing procedure, clinical stage, age, surgical procedure (open vs laparoscopic), and catheter time were all independent predictors (P <.05) of continence recovery. In our study, only prostate volume and not the other variables (age, surgical technique, prostate-specific antigen level, staging, and Gleason score) were significantly (P ¼.0001) and independently correlated to the time for continence achievement. In both groups, prostate volume was higher and times to continence recovery using BFþFES treatment were longer. The results of our prospective analysis show that it is not necessary to do this rehabilitative treatment for everyone starting early after catheter removal after RP, but you can wait and use it only for the patients who need it, as they remain incontinent after several months. A randomized comparison of this treatment 1 year after prostatectomy is still lacking and also the reproducibility of these results in another center is not yet given. References 1. MacDonald R, Fink HA, Huckabay C, et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int. 2002;100: 76-85. 2. Kongtragul J, Tukhanon W, Tudpudsa P, et al. Effects of adding concentration therapy to Kegel exercise to improve continence after radical prostatectomy, randomized control. J Med Assoc Thai. 2014; 97:513-517. 3. Patel MI, Yao J, Hirschhorn AD, Mungovan SF. Preoperative pelvic floor physiotherapy improves continence after radical retropubic prostatectomy. Int J Urol. 2013;20:986-992. 4. Donnelian SM, Duncan HJ, MacGregor RJ, Russell JM. Prospective assessment of incontinence after radical retropubic
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prostatectomy: objective and subjective analysis. Urology. 1997; 49:225-230. Yamanishi T, Mizuno T, Watanabe M, et al. Randomized placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. J Urol. 2010;184:2007-2012. Song C, Doo CK, Hong JH, et al. Relationship between the integrity of the pelvic floor muscle and early recovery of continence after radical prostatectomy. J Urol. 2007;178:208-214. Kundu SD, Roehl KA, Eggener SE, et al. Potency, continence and complications in 3477 consecutive radical retropubic prostatectomies. J Urol. 2004;172:2227-2231. Sacco E, Prayer Galetti T, Pinto F, et al. Urinary incontinence after radical prostatectomy: incidence by definition, risk factors and temporal trend in a large series with a long term follow-up. BJU Int. 2006;97:1234-1241. Filocamo MT, Li Marzi V, Del Popolo G, et al. Effectiveness of early pelvic floor rehabilitation treatment for post prostatectomy incontinence. Eur Urol. 2005;48:734-745. Floratos DL, Sonke GS, Rapidou CA, et al. Biofeedback vs verbal feedback as learning tools for pelvic muscle exercises in the early management of urinary incontinence after radical prostatectomy. BJU Int. 2002;89:714-723. Bauer RM, Bastian PJ, Gozzi C, et al. Postprostatectomy incontinence all about diagnosis and management. Eur Urol. 2009;55: 322-334. Parekh AH, Feng MI, Karages D, et al. The role of pelvic floor exercise on post-prostatectomy incontinence. J Urol. 2003;170: 130-139. Mariotti G, Sciarra A, Gentilucci A, et al. Early recovery of urinary continence after radical prostatectomy using early pelvic floor electrical stimulation and biofeedback associated treatment. J Urol. 2009;181:1788-1793. Moore KN, Griffiths D, Hunghton A, et al. Urinary incontinence after radical prostatectomy a randomized controlled trial comparing pelvic muscle exercise with or without electrical stimulation. BJU Int. 1999;83:57-65. Van Poppel H, Collette L, Kirkali Z, et al. Quality control of radical prostatectomy and feasibility study. Eur J Cancer. 2001;37: 884-896. Lepor H, Nieder AM, Ferrandino MN, et al. Intraoperative and postoperative complications of radical retropubic prostatectomy in a consecutive series of 1000 cases. J Urol. 2001;166:17291735. Tienforti D, Sacco E, Marangi F, et al. Efficacy of an assisted low intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial. BJU Int. 2012; 110:1004-1011. Geraerts I, Van Poppel HV, Devoogdt N, et al. Influence of preoperative and postoperative pelvic floor muscle training compared with postoperative PFMT on urinary incontinence after radical prostatectomy: a randomized controlled trial. Eur Urol. 2013;64: 766-772. Ribeiro LH, Prota C, Gomes CM, et al. Long-term effect of early postopertaive pelvic floor biofeedback on continence in men undergoing radical prostatectomy: a prospective, randomized, controlled trial. J Urol. 2010;184:1034-1036. Palisaar JR, Roghmann F, Brock M, et al. Predictors of short-term recovery of urinary continence after radical prostatectomy. World J Urol. 2014; (Epud ahead of print).
APPENDIX SUPPLEMENTARY DATA
Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/j.urology. 2015.02.064.
UROLOGY 86 (1), 2015
EDITORIAL COMMENT
REPLY 1
In the present analysis, the authors did not use a control group but they compared the same treatment—exercises with biofeedback (BF) immediately followed by pelvic floor electrical stimulation (FES)—at different intervals from surgery (2 weeks after catheter removal vs 12 months after surgery). Urinary leakage weight had to be 50 g or more in both groups. It is well known that a large proportion of patients who present with incontinence 2 weeks after radical prostatectomy will become continent with or without physical therapy or FES. No wonder that the results were a little better in the early group, because in this group, there are many patients who do not need the treatment. They would become continent spontaneously only by waiting for a few months. This is not the case for patients who are still incontinent after 1 year. The authors have compared worse patients (the ones that remain incontinent after 1 year) with better patients (the ones that have a good chance to become continent without BF plus FES). This explains why there was a significant difference in continence only at 2 and 4 weeks, but surprisingly, the end result after 6 months of treatment was almost the same. The authors have therefore not shown that early therapy is better than late therapy, but they have examined whether one can wait with this treatment and start the treatment late (after 1 year) instead of starting early. And it seems that this is the case. Because the final treatment results (continence) were not significantly different in the late group compared with the early group. Unfortunately, it cannot be differentiated whether this effect is due to BF or rather FES, because both the treatments were used in combination. The logical conclusion would be, “it is not necessary to do this costly and time-consuming treatment for everyone starting early after catheter removal, but you can wait and use it only for the patients who need it, as they remain incontinent after several months, but a randomized comparison of this treatment 1 year after prostatectomy is still lacking and also the reproducibility of these results in another center is not yet available.” Nikolaus T. Schmeller, M.D., Urologische Abteilung, Kkh. der Barm. Brueder, Salzburg, Austria
In part, we agree with the editorial comment submitted by Dr Schmeller regarding our article.2 Our study did not use a control group but we compared the same treatment for the recovery of urinary continence (UC) (biofeedback [BF] plus electrical stimulation [FES]) at different intervals from radical prostatectomy (RP; 2 weeks after catheter removal vs 12 months after surgery). However, in a previous study,1 we analyzed the advantageous effect of the early combined use of BF and FES on the early recovery of UC after RP in a randomized study using as control cases submitted to only verbal instructions for pelvic floor muscle training. The mean leakage weight became significantly lower (P <.05) in the active group than in the control group starting at 4 weeks until 6 months of follow-up. We also agree that our actual study did not demonstrate that early therapy is better than late therapy but that BF plus FES can be successfully done either early or also after 1 year from surgery. We do not completely agree with the conclusion of Dr Schmeller that it is not necessary to do this costly and timeconsuming treatment starting early after catheter removal but we can wait and use it only after 1 year. An important advantage and aim for all patients is to rapidly and completely recover UC after surgery, and therefore, our noninvasive rehabilitative program can be offered early to all patients who need it after surgery. It is not a preventive treatment for all but must be used as early as possible in patients who need it after RP. Using it with this modality, the treatment is not costly and time consuming and can reduce global cost for the management of UC, and time is well consumed by the patient. Alessandro Sciarra, M.D., Prostate Unit, Department of Urological Sciences, University Sapienza, Rome, Italy Gianna Mariotti, M.D., Department of Urological Sciences, University Sapienza, Rome, Italy
References
1. Mariotti G, Salciccia S, Innocenzi M, et al. Recovery of urinary continence after radical prostatectomy using early vs late pelvic floor electrical stimulation and biofeedback-associated treatment. Urology. 2015;86:115-121.
1. Mariotti G, Sciarra A, Gentilucci A, et al. Early recovery of urinary continence after radical prostatectomy using early pelvic floor electrical stimulation and biofeedback associated treatment. J Urol. 2009; 181:1788-1793. 2. Mariotti G, Salciccia S, Innocenzi M, et al. Recovery of urinary continence after radical prostatectomy using early vs late pelvic floor electrical stimulation and biofeedback-associated treatment [editorial comment]. Urology. 2015;86:115-121.
http://dx.doi.org/10.1016/j.urology.2015.02.065
http://dx.doi.org/10.1016/j.urology.2015.02.066
UROLOGY 86: 121, 2015. 2015 Elsevier Inc.
UROLOGY 86: 121, 2015. 2015 Elsevier Inc.
Reference
UROLOGY 86 (1), 2015
121
RESULTS
CONCLUSION
To compare the early vs late use of pelvic floor electrical stimulation (FES) plus biofeedback (BF) in terms of time to recovery and rate of continence after radical prostatectomy (RP). Between April 2007 and April 2012, a total of 120 patients who underwent RP were prospectively included in the study. In group 1 (60 cases), we included patients who presented a urinary leakage weight 50 g for 24 hours, 14 days after catheter removal. In group 2 (60 cases), we included patients who continued to present a urinary leakage weight 50 g for 24 hours, 12 months after surgery. In both groups, patients were prospectively submitted to the same program of BFþFES. Mean leakage weight became significantly lower (P <.002) in group 1 than in group 2 starting from visit 1 (2 weeks) through visit 7 (24 weeks). However, a significant difference (P <.05) between the 2 groups in terms of percentage of continent patients was achieved only at 2 weeks (group 1 ¼ 20%; group 2 ¼ 0%) and 4 weeks (group 1 ¼ 66.7%; group 2 ¼ 46.7%). The objective continence rate 6 months after the beginning of treatment was 96.7% in group 1 and 91.7% in group 2. In our experience, the treatment with BF and FES has a significant positive effect on the recovery of urinary continence independently to the time in which it is used (early vs delayed). This protocol might represent a noninvasive method for all patients undergoing RP, also in a 12month interval from surgery. UROLOGY 86: 115e121, 2015. 2015 Elsevier Inc.
D
espite relevant improvements in the surgical technique, radical prostatectomy (RP) remains one of the most important causes of iatrogenic incontinence in men. Reported prevalence rates of urinary incontinence (UI) after RP vary from 5% to >60% according to both the criteria used to define incontinence and the postoperative time of assessment.1,2 The prevalence and severity of UI decreases with postoperative time: 8%-87% of patients have UI at 6 months postoperatively and 5%-44% at 12 months postoperatively.3,4 The etiology of post-RP UI is not completely understood, but it primarily results from sphincter insufficiency, detrusor overactivity, reduced bladder compliance, and
Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, Policlinico Umberto I, Rome, Italy; the Department of Urology, University Sapienza, Rome, Italy; the Prostate Unit, Department of Urology, Policlinico Umberto I, University Sapienza, Rome, Italy; and the Italian National Statistical Institute, Rome, Italy Address correspondence to: Alessandro Sciarra, M.D., Prostate Unit, Department of Urology, Policlinico Umberto I, University Sapienza, Viale Policlinico, Rome 155 00161, Italy. E-mail: [email protected] Submitted: January 17, 2015, accepted (with revisions): February 27, 2015
ª 2015 Elsevier Inc. All Rights Reserved
decreased contractility.5,6 Prognostic factors for post-RP UI include age, previous bladder surgery, nerve-sparing status, anastomotic stricture, and surgical experience.7,8 Various noninvasive treatments have been analyzed.9,10 Pelvic floor muscle training (PFMT) is the most widely used noninvasive method of increasing pelvic floor muscle strength.11,12 However, it can take several months to restore continence and some patients have persistent incontinence despite treatment.5 In a previous study13 on cases submitted to RP, we compared the benefit of the early combined use of functional pelvic floor electrical stimulation (FES) and biofeedback (BF) with PFMT. Our analysis showed that the early (7 days after catheter removal) noninvasive treatment with FESþBF has a significant positive effect on the early recovery of urinary continence (at 4 weeks 63% continent with FESþBF vs 30% with PFMT) after surgery, also maintained in the long term (at 6 months 96.7% continent with FESþBF vs 66.7% with PFMT). Post-RP UI has a significant negative effect on postoperative health-related quality of life. Therefore, conservative treatments with a potential to reduce early UI http://dx.doi.org/10.1016/j.urology.2015.02.064 0090-4295/15
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Table 1. Patient characteristics at baseline Characteristic Number of patients Age (y), mean SD; median and range Preoperative PSA (ng/mL), mean SD; median and range Pathologic stage, n pT2N0 pT3No Pathologic Gleason score, n 7 (3þ4) or less 7 (4þ3) or greater Surgical technique RP, n Laparoscopic Open Nerve-sparing procedure, % Yes (unilateral or bilateral) No Postoperative PSA (ng/mL), mean SD; median and range Catheter removal (d) Leakage wt/24 h (g), mean SD; median and range Prostate volume (cm3), mean SD; median and range
Group 1 60 59.61 4.03 (60); 50-67 6.95 2.40 (7.5); 3.5-12.0
Group 2 60 59.28 4.19 (60); 50-67 6.97 2.32 (7.7); 3.0-12.0
P Value(2-Tailed t Test) — >.05 >.05
54 6
55 5
>.05
48 12
46 14
>.05
20 40
22 38
>.05
42 18 0.05 0.03 (0.05); 0.01-0.1 14 295.0 141.03 (300); 50-700 46.91 8.44 (45); 35-70
44 16 0.04 0.02 (0.04); 0.01-0.1 14 322.5 135.11 (300); 50-700 49.41 7.65 (50); 35-70
>.05 >.05 — >.05 >.05
PSA, prostate-specific antigen; RP, radical prostatectomy; SD, standard deviation.
are of relevant clinical interest. However, in the clinical practice, not always it is possible or the patient accepts an early physical treatment for UI, and a percentage of cases are managed only with verbal indications for exercises. In cases with persistent UI after several months from RP, the choice of noninvasive procedures such as FES or BF could remain valid. We tried to evaluate whether the positive results on post-RP UI obtained with the combination of FESþBF in the early interval from surgery (<1 months) can be maintained also in cases with persistent UI after a long interval (12 months) from RP. The aim of this prospective study was to analyze and to compare the early vs late use of FESþBF as a learning tool for pelvic floor muscle exercises in terms of time to recovery and rate of continence after RP.
MATERIALS AND METHODS Population Between April 2007 and April 2012, a total of 120 patients who underwent RP at our institution for clinically localized prostate cancer were included in the study. Patient characteristics are described in Table 1. Exclusion criteria were prior bladder or prostate surgery, prior urinary or fecal incontinence, neurogenic dysfunction, preoperative history of overactive bladder, and psychiatric history or significant perioperative complications. None of these patients received radiotherapy after RP. No patient was prescribed anticholinergic drugs (or other drugs able to influence urinary continence) during the study. Patients were divided into 2 groups. In group 1 (60 cases), we included patients submitted to RP who presented a urinary leakage weight 50 g for 24 hours, 14 days after catheter removal. All cases were considered for an early treatment that began 14 days after catheter removal. 116
In group 2 (60 cases), we included cases submitted to RP who continued to present a urinary leakage weight 50 g for 24 hours, 12 months after surgery. During this year, cases received only usual instructions to conduct pelvic muscle exercises (PME), which included verbal instruction (how to correctly and selectively contract the anal sphincter while relaxing the abdominal muscles) by the urologist and written examples of exercises (Kegel exercises).
Treatment Patients were enrolled in a prospective analysis in both groups (1 and 2). All cases signed an informed consent before treatment and the protocol was approved by our internal ethical committee. In both groups, patients were submitted to the same program of BFþFES performed by the same clinician (G.M.). In group 1, the program started 14 days after catheter removal (early program), whereas in group 2, 12 months after surgery (late program). The BFþFES program was described in a previous article.13 Patients met the clinician twice a week for 6 weeks. Each of the 12 treatment sessions was homogeneously composed of a first part with BF (15 minutes) followed by a second part with FES (20 minutes). Thus, each session lasted 35 minutes. Patients were placed in a supine decubital position. For FES, a surface electrode was inserted into the anus and pulsed at 30 Hz (first 10 minutes) and 50 Hz (second 10 minutes) square waves at a 300-ms pulse duration and a maximal output current of 24 mA. The intensity was adequate to induce visual lifting of the levator ani and pubococcygeus muscle, considering the level of comfort of the patient.14 For BF, a 2channel electromyographic BF apparatus (Reactive Biofeedback; BEAC, Stradella, Italy) was used, with 1 channel for perineal and the other for abdominal muscle and the signal received through surface electrodes.10 During the initial 2-3 sessions, a strong emphasis was placed on the specificity of muscle contraction (contraction of pelvic muscles with UROLOGY 86 (1), 2015
Figure 1. Mean leakage weight variation in the 2 groups at different intervals of follow-up. (Color version available online.) minimum activity of abdominal muscles). During the following sessions, the exercises were designed to increase the power and endurance of the pelvic floor muscles. Verbal guidance of the contractions was also used to instruct the patient how to correctly continue the exercises at home. Initially, the patients performed these exercises while supine but later also when sitting or standing during normal daily activity.
Outcomes Assessment In both groups (1 and 2), the evaluation was performed at time 0 (before treatment beginning and 14 days after catheter removal in group 1 and 12 months after surgery in group 2), during follow-up at 2 and 4 weeks and 2, 3, 4, 5, and 6 months. UI was objectively assessed using the 24-hour pad test and the number of pads used (primary outcome). Objective continence was defined as no pad use (pad weight gain during the test of 2 g or less).14 Subjective evaluation (secondary outcome) was made using the incontinence section of the International Continence Society (ICS)-male questionnaire.15 Moreover, patients were asked to keep a voiding diary including the number of incontinence episodes, the number and volume of voids, and the number of pads used. Because urodynamic studies are invasive, they were avoided and used only in cases with UI after the 6month follow-up (according to ICS standards).16 At 12month interval, the percentage of continent (no pad use) cases was also reported.
Statistical Analysis The study was designed to have an 80% power to detect a difference in improvement rates for a 2-tailed test with 5% type UROLOGY 86 (1), 2015
I error. A 2-tailed t test with 5% type I error was used to compare variables between the 2 groups. A Welch 2-sample t test was used to verify differences in the proportion of patients in the 2 groups who were continent at various follow-up intervals. Univariate and multivariate stepwise regression analysis of the risk factors for incontinence (age, prostate volume, stage, and surgical technique) was performed. A P value <.05 was considered statistically significant. An R 3.1.1 statistical software was used.
RESULTS A total of 120 cases were included in the evaluation. At time 0, no significant differences between group 1 (early treatment) and group 2 (late treatment) were present (Table 1). All patients were evaluable for the entire follow-up and all completed the BFþFES program. No complications were found in any patient and no cases complained of discomfort or irritation from the probe. At time 0, the mean leakage weight for 24 hours was 295.0 141.03 g in group 1 and 322.5 135.11 g in group 2 (P ¼ .2776; Table 1). Mean leakage weight became significantly lower (P < .002) in group 1 than in group 2 starting from visit 1 (2 weeks) through visit 7 (24 weeks; Fig. 1; Table 2). In both groups (1 and 2), a significant (P < .05) reduction in mean leakage weight compared with time 0 was observed from visit 1 (2 weeks) through visit 7 (24 weeks). A significant difference (P < .05) between the 2 groups in terms of percentage of continent patients was achieved 117
Table 2. Mean leakage weight in grams at the different intervals Time Intervals
Group 1, Mean SD; Median (range)
Group 2, Mean SD; Median (range)
P Value
Time 0 Visit 1 (2 wk) Visit 2 (4 wk) Visit 3 (8 wk) Visit 4 (12 wk) Visit 5 (16 wk) Visit 6 (20 wk) Visit 7 (24 wk)
295.0 141.03; 300.0 (50.0-700.0) 153.83 108.22; 100.0 (0-500.0) 84.83 96.48; 50.0 (0-400.0) 52.48 74.77; 30.0 (0-400.0) 29.65 59.60; 0 (0-300.0) 16.65 37.76; 0 (0-200.0) 10.48 30.66; 0 (0-200.0) 6.98 20.10; 0 (0-100.0)
322.50 135.11; 300.0 (50.0-700.0) 217.50 102.02; 200.0 (50.0-500.0) 133.0 105.53; 100 (0-400.0) 92.0 75.95; 50 (0-300.0) 65.16 54.38; 50 (0-200.0) 49.0 44.02; 50 (0-200.0) 37.33 32.30; 40 (0-150.0) 28.16 30.55; 30 (0-100.0)
.2776 .0012 .0102 .0048 .0008 <.0001 <.0001 <.0001
Abbreviations as in Table 1.
Figure 2. Percent of continent patients in the 2 groups at different intervals of follow-up. (Color version available online.)
only at 2 weeks (group 1 ¼ 20%; group 2 ¼ 0%) and 4 weeks (group 1 ¼ 66.7%; group 2 ¼ 46.7%; Fig. 2; Supplementary Tables 1 and 2). In all other intervals, although the percentage of continent cases was always higher in group 1 than in group 2, differences did not reach significance (P > .05). Results on ICS-male questionnaire on incontinence at the different intervals are described in Supplementary Table 2. In both groups, only prostate volume was significantly and independently associated with the time of continence achievement (univariate and multivariate regression analysis; P ¼ .0001) (Supplementary Table 3). In particular, prostate volume was higher and times to continence recovery using BFþFES treatment were longer. At the end of the follow-up (6 months), 3.3% (2 patients) in group 1 and 8.3% (5 patients) in group 2 118
remained incontinent (1, urine loss >2 g). Therefore, the objective continence rate 6 months after the beginning of treatment was 96.7% in group 1 and 91.7% in group 2. All incontinent cases at visit 7 underwent urodynamic evaluation that showed sphincter deficiency in 1 of 2 in group 1 and 3 of 5 in group 2 and detrusor overactivity in 1 of 2 in group 1 and 2 of 5 in group 2. After 1 year in both groups the same percentage of cases reported at 6 months (group 1 ¼ 96.7%; group 2 ¼ 91.7%) maintained continence.
COMMENT UI after RP is mainly determined by a sphincter deficiency caused by anatomic and functional changes during surgery.5,6 As a noninvasive treatment, behavioral UROLOGY 86 (1), 2015
training using PFMT seems to be a logical approach. Kegel first proposed PFMT to improve urinary control, and various studies analyzed its role in post-RP UI.3,9,17,18 Filocamo et al9 analyzed 300 cases treated with RP randomly assigned to early PFMT (at catheter removal) vs control. A significantly (P <.001) greater percentage of patients in the treated group vs controls achieved continence after 6 months (94.6% vs 65.0%). Patel et al3 retrospectively analyzed 284 men undergoing RP. The intervention group received physiotherapist-guided PFMT, whereas the control group was provided with verbal instruction on exercises by the surgeon alone. At 6 weeks after operation, the 24-h pad weight was significantly lower (9 g vs 17 g; P <.01) for the intervention group. Geraerts et al18 randomly analyzed 180 men who underwent RP (open and laparoscopic); patients treated with additional preoperative PFMT had no shorter duration of postoperative UI compared with only postoperative PFMT (P ¼ .878). Floratos et al10 found similar (91%) objective continence rates at 6 months after RP using electromyographic BF or verbal instruction for PFMT. On the contrary, Ribeiro et al19 on 73 patients submitted to RP reported that early BF not only hastens the recovery of urinary continence after surgery but allows for significant improvements in the severity of incontinence. Furthermore, FES has been described as a conservative treatment of UI after RP. Moore et al14 compared the advantageous effect of the association of FES and PFMT to PFMT alone in terms of post-RP UI. They started treatment only after 8 or more weeks from surgery. After only 12 weeks of analysis, they demonstrated no significant (P >.05) differences in overall urine loss between the 2 groups. Yamanishi et al5 analyzed 56 men with severe UI after RP. In the group treated with FESþPFMT, a significantly higher percentage (P <.05) of continent patients when compared to the group treated with PFMT alone was observed from 1 month to 6 months of follow-up (81% vs 44% at 6 months). In a previous study,13 we analyzed the advantageous effect of the early combined use of BF and FES on the early recovery of UI after RP. Sixty cases were prospectively randomized to a treatment group with FES and BF starting 7 days after catheter removal vs a control group with verbal instructions for PFMT. The mean leakage weight became significantly lower (P <.05) in the active group than in the control group starting at 4 weeks until 6 months of follow-up. A significant difference (P <.05) between the 2 groups in terms of percentage of continent patients was achieved from 4 weeks (63% vs 30%) to 6 months (96% vs 66%). Most of the studies in the literature showed that an early noninvasive treatment of post-RP UI is feasible and significantly improves continence rate and time to recovery. However, in the clinical practice, not always it is possible or the patient accepts an early physical treatment for UI and a significant percentage of cases UROLOGY 86 (1), 2015
are managed only with verbal instructions for exercises. In cases with persistent UI after several months from RP, the choice of noninvasive procedures such as FES or BF could remain valid. We tried to evaluate whether the positive results on post-RP UI obtained with the combination of FESþBF in the early interval from surgery (<1 months) can be maintained also in cases with persistent UI after a long interval (12 months) from RP. The significance of our study is based on the prospective analysis, on the homogeneous characteristics of the 2 groups, and on the objective evaluation of outcome assessment. In particular, all patients underwent standard RP (open or laparoscopic), and in all cases, the catheter was removed after a similar interval. Patients were considered continent only when no pads were required and the weight gain of the pad during the test was 2 g. A more objective evaluation of UI would be a urodynamic study. However, these investigations are invasive, especially soon after surgery. Thus in our study, as previously reported, urodynamics were postponed and used only in refractory cases after 6 months.9,13 Limitations of our study included no measurement of urinary control results in terms of improved quality of life and costs of health care. Moreover, a control untreated group was not included, and this aspect produces an only hypothesis-generating analysis. Treatment was homogeneously performed in all cases of both groups for 12 sessions. BF and FES were performed in each session. The rationale for placing BF and FES in the same session is to perform 3 consecutive steps in each session (1) to emphasize the specificity of muscle contraction (BF), (2) to increase the power and endurance of pelvic floor muscles (BF), and (3) to artificially stimulate and increase the periurethral striated muscle (FES).13 This type of session also helps patients to better perform and continue exercises at home. If muscles work efficiently (BFþFES), it is easier for the patient to create an autonomic pelvic floor contraction to prevent stress events.13 Fatigue of the periurethral striated muscles is often the cause of increased urine loss during the second part of the day and this can be prevented by BFþFES sessions.13 It is not possible to estimate the exact contribution of each method to the final results, but BF and FES work together in this setup. In the present analysis, we did not use a control group as in the first study,13 but we compared the same treatment (BFþFES) at different intervals from surgery (early vs late). The benefit of this physical treatment using the combination of BF and FES is particularly evident in the early recovery of continence and in the reduction of urine leakage, already at 2 weeks from the beginning. Afterward, benefits are maintained also at treatment end till the 6-month control. Compared with other protocols reported in the literature,3,5,9,10 our combined treatment produced a high percentage of continent patients (>90%). It is also important to emphasize the safety of this protocol. It is not harmful, has a complete 119
compliance, and does not compromise future treatment options. In the early treatment group (group 1), we confirmed the positive results described in our previous study.13 During the follow-up, mean leakage weight was always significantly lower in the early vs the late treatment group. However, only at 2- and 4-week intervals the percentage of continent cases was significantly higher in the early vs the late treatment group. The initiation of the treatment program soon after surgery, when patients have not become accustomed to the idea of wearing a pad, contributes to these significant results and might explain the complete compliance. However, the results and the fact that >90% of cases reached continence at 6-months follow-up in the late treatment group encourage the use of our program also in cases with a persistent leakage 1 year after surgery. Palisaar et al20 evaluated 22 clinical and oncologic variables to determine whether they were associated with early urinary continence status after physical treatment for post-RP UI. At the univariate analysis, age, clinical stage, prostate-specific antigen level, prior prostate surgery, Gleason score, nerve-sparing status, and catheter time were significant predictors (P < .05). On multivariate analysis, nerve-sparing procedure, clinical stage, age, surgical procedure (open vs laparoscopic), and catheter time were all independent predictors (P <.05) of continence recovery. In our study, only prostate volume and not the other variables (age, surgical technique, prostate-specific antigen level, staging, and Gleason score) were significantly (P ¼.0001) and independently correlated to the time for continence achievement. In both groups, prostate volume was higher and times to continence recovery using BFþFES treatment were longer. The results of our prospective analysis show that it is not necessary to do this rehabilitative treatment for everyone starting early after catheter removal after RP, but you can wait and use it only for the patients who need it, as they remain incontinent after several months. A randomized comparison of this treatment 1 year after prostatectomy is still lacking and also the reproducibility of these results in another center is not yet given. References 1. MacDonald R, Fink HA, Huckabay C, et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int. 2002;100: 76-85. 2. Kongtragul J, Tukhanon W, Tudpudsa P, et al. Effects of adding concentration therapy to Kegel exercise to improve continence after radical prostatectomy, randomized control. J Med Assoc Thai. 2014; 97:513-517. 3. Patel MI, Yao J, Hirschhorn AD, Mungovan SF. Preoperative pelvic floor physiotherapy improves continence after radical retropubic prostatectomy. Int J Urol. 2013;20:986-992. 4. Donnelian SM, Duncan HJ, MacGregor RJ, Russell JM. Prospective assessment of incontinence after radical retropubic
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prostatectomy: objective and subjective analysis. Urology. 1997; 49:225-230. Yamanishi T, Mizuno T, Watanabe M, et al. Randomized placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. J Urol. 2010;184:2007-2012. Song C, Doo CK, Hong JH, et al. Relationship between the integrity of the pelvic floor muscle and early recovery of continence after radical prostatectomy. J Urol. 2007;178:208-214. Kundu SD, Roehl KA, Eggener SE, et al. Potency, continence and complications in 3477 consecutive radical retropubic prostatectomies. J Urol. 2004;172:2227-2231. Sacco E, Prayer Galetti T, Pinto F, et al. Urinary incontinence after radical prostatectomy: incidence by definition, risk factors and temporal trend in a large series with a long term follow-up. BJU Int. 2006;97:1234-1241. Filocamo MT, Li Marzi V, Del Popolo G, et al. Effectiveness of early pelvic floor rehabilitation treatment for post prostatectomy incontinence. Eur Urol. 2005;48:734-745. Floratos DL, Sonke GS, Rapidou CA, et al. Biofeedback vs verbal feedback as learning tools for pelvic muscle exercises in the early management of urinary incontinence after radical prostatectomy. BJU Int. 2002;89:714-723. Bauer RM, Bastian PJ, Gozzi C, et al. Postprostatectomy incontinence all about diagnosis and management. Eur Urol. 2009;55: 322-334. Parekh AH, Feng MI, Karages D, et al. The role of pelvic floor exercise on post-prostatectomy incontinence. J Urol. 2003;170: 130-139. Mariotti G, Sciarra A, Gentilucci A, et al. Early recovery of urinary continence after radical prostatectomy using early pelvic floor electrical stimulation and biofeedback associated treatment. J Urol. 2009;181:1788-1793. Moore KN, Griffiths D, Hunghton A, et al. Urinary incontinence after radical prostatectomy a randomized controlled trial comparing pelvic muscle exercise with or without electrical stimulation. BJU Int. 1999;83:57-65. Van Poppel H, Collette L, Kirkali Z, et al. Quality control of radical prostatectomy and feasibility study. Eur J Cancer. 2001;37: 884-896. Lepor H, Nieder AM, Ferrandino MN, et al. Intraoperative and postoperative complications of radical retropubic prostatectomy in a consecutive series of 1000 cases. J Urol. 2001;166:17291735. Tienforti D, Sacco E, Marangi F, et al. Efficacy of an assisted low intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial. BJU Int. 2012; 110:1004-1011. Geraerts I, Van Poppel HV, Devoogdt N, et al. Influence of preoperative and postoperative pelvic floor muscle training compared with postoperative PFMT on urinary incontinence after radical prostatectomy: a randomized controlled trial. Eur Urol. 2013;64: 766-772. Ribeiro LH, Prota C, Gomes CM, et al. Long-term effect of early postopertaive pelvic floor biofeedback on continence in men undergoing radical prostatectomy: a prospective, randomized, controlled trial. J Urol. 2010;184:1034-1036. Palisaar JR, Roghmann F, Brock M, et al. Predictors of short-term recovery of urinary continence after radical prostatectomy. World J Urol. 2014; (Epud ahead of print).
APPENDIX SUPPLEMENTARY DATA
Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/j.urology. 2015.02.064.
UROLOGY 86 (1), 2015
EDITORIAL COMMENT
REPLY 1
In the present analysis, the authors did not use a control group but they compared the same treatment—exercises with biofeedback (BF) immediately followed by pelvic floor electrical stimulation (FES)—at different intervals from surgery (2 weeks after catheter removal vs 12 months after surgery). Urinary leakage weight had to be 50 g or more in both groups. It is well known that a large proportion of patients who present with incontinence 2 weeks after radical prostatectomy will become continent with or without physical therapy or FES. No wonder that the results were a little better in the early group, because in this group, there are many patients who do not need the treatment. They would become continent spontaneously only by waiting for a few months. This is not the case for patients who are still incontinent after 1 year. The authors have compared worse patients (the ones that remain incontinent after 1 year) with better patients (the ones that have a good chance to become continent without BF plus FES). This explains why there was a significant difference in continence only at 2 and 4 weeks, but surprisingly, the end result after 6 months of treatment was almost the same. The authors have therefore not shown that early therapy is better than late therapy, but they have examined whether one can wait with this treatment and start the treatment late (after 1 year) instead of starting early. And it seems that this is the case. Because the final treatment results (continence) were not significantly different in the late group compared with the early group. Unfortunately, it cannot be differentiated whether this effect is due to BF or rather FES, because both the treatments were used in combination. The logical conclusion would be, “it is not necessary to do this costly and time-consuming treatment for everyone starting early after catheter removal, but you can wait and use it only for the patients who need it, as they remain incontinent after several months, but a randomized comparison of this treatment 1 year after prostatectomy is still lacking and also the reproducibility of these results in another center is not yet available.” Nikolaus T. Schmeller, M.D., Urologische Abteilung, Kkh. der Barm. Brueder, Salzburg, Austria
In part, we agree with the editorial comment submitted by Dr Schmeller regarding our article.2 Our study did not use a control group but we compared the same treatment for the recovery of urinary continence (UC) (biofeedback [BF] plus electrical stimulation [FES]) at different intervals from radical prostatectomy (RP; 2 weeks after catheter removal vs 12 months after surgery). However, in a previous study,1 we analyzed the advantageous effect of the early combined use of BF and FES on the early recovery of UC after RP in a randomized study using as control cases submitted to only verbal instructions for pelvic floor muscle training. The mean leakage weight became significantly lower (P <.05) in the active group than in the control group starting at 4 weeks until 6 months of follow-up. We also agree that our actual study did not demonstrate that early therapy is better than late therapy but that BF plus FES can be successfully done either early or also after 1 year from surgery. We do not completely agree with the conclusion of Dr Schmeller that it is not necessary to do this costly and timeconsuming treatment starting early after catheter removal but we can wait and use it only after 1 year. An important advantage and aim for all patients is to rapidly and completely recover UC after surgery, and therefore, our noninvasive rehabilitative program can be offered early to all patients who need it after surgery. It is not a preventive treatment for all but must be used as early as possible in patients who need it after RP. Using it with this modality, the treatment is not costly and time consuming and can reduce global cost for the management of UC, and time is well consumed by the patient. Alessandro Sciarra, M.D., Prostate Unit, Department of Urological Sciences, University Sapienza, Rome, Italy Gianna Mariotti, M.D., Department of Urological Sciences, University Sapienza, Rome, Italy
References
1. Mariotti G, Salciccia S, Innocenzi M, et al. Recovery of urinary continence after radical prostatectomy using early vs late pelvic floor electrical stimulation and biofeedback-associated treatment. Urology. 2015;86:115-121.
1. Mariotti G, Sciarra A, Gentilucci A, et al. Early recovery of urinary continence after radical prostatectomy using early pelvic floor electrical stimulation and biofeedback associated treatment. J Urol. 2009; 181:1788-1793. 2. Mariotti G, Salciccia S, Innocenzi M, et al. Recovery of urinary continence after radical prostatectomy using early vs late pelvic floor electrical stimulation and biofeedback-associated treatment [editorial comment]. Urology. 2015;86:115-121.
http://dx.doi.org/10.1016/j.urology.2015.02.065
http://dx.doi.org/10.1016/j.urology.2015.02.066
UROLOGY 86: 121, 2015. 2015 Elsevier Inc.
UROLOGY 86: 121, 2015. 2015 Elsevier Inc.
Reference
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