Conservative Treatment of Postprostatectomy Incontinence

Study Overview
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Brief Summary
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The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.

Detailed Description
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The primary purpose of this project is to test the effectiveness, impact on quality of life, and durability of conservative therapies for persistent post-prostatectomy urinary incontinence in a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation. The second purpose of the study is to examine and compare the cost-effectiveness of the 8-week, multi-component behavioral training program to the same program with the addition of biofeedback and pelvic floor electrical stimulation. Prostate cancer is the most common internal cancer in men in the United States. The most common treatment for early disease is radical prostatectomy, the removal of the prostate gland. The two most common sequelae of prostatectomy are incontinence and erectile dysfunction. The incontinence improves and often resolves in the first year after prostatectomy, but surveys of patients show that 40% of men have incontinence severe enough to require pads 1 and 2 years after their surgery. There are currently no randomized, controlled studies of non-surgical treatments for persistent post-prostatectomy incontinence.

Official Title
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Conservative Treatment of Postprostatectomy Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Behavioral: Behavioral Therapy
* Device: Pelvic Floor Electrical Stimulation
* Behavioral: Biofeedback
* Other: No Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Involuntary loss of urine that started immediately after radical prostatectomy and has persisted for at least one year. One-week bladder diary with interpretable data and at least two incontinence episodes Exclusion Criteria: Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina Cardiac pacemaker or implanted cardiac defibrillator Current use of anticholinergic agents for detrusor instability Folstein's Mini-Mental State Exam score below 24 (impaired mental status) One-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents. Poorly controlled diabetes, defined as (glycosylated hemoglobin > 9 within last 3 months). Hematuria on microscopic examination. Enrollment will be permitted after urologic evaluation. Urodynamic evaluation: Post-void residual volume greater than 200 mL
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Therapy<br>Behavioral Therapy (Pelvic floor muscle training, bladder control strategies) | Behavioral: Behavioral Therapy<br>* Pelvic Floor Muscle Exercises and Bladder control strategies<br>|
| Experimental: Behavioral Therapy Plus Technologies<br>Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback) | Behavioral: Behavioral Therapy<br>* Pelvic Floor Muscle Exercises and Bladder control strategies<br>Device: Pelvic Floor Electrical Stimulation<br>* Pelvic Floor Electrical Stimulation daily for 8 weeks<br>Behavioral: Biofeedback<br>* Pelvic Floor Muscle training via biofeedback<br>|
| Placebo Comparator: Placebo Comparator<br>No treatment control | Other: No Treatment<br>* No treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Incontinence Episodes on Bladder Diary | [(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100% | 2 months | 
| Percent Change in Incontinence Episodes Per Week on Bladder Diary | [(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100% | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, therapy, prostatectomy, prostate cancer