Conservative Treatment of Postprostatectomy Incontinence

Not Applicable

Completed

Interventions: Other: No Treatment
Behavioral: Behavioral Therapy
Device: Pelvic Floor Electrical Stimulation
Behavioral: Biofeedback

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	No Treatment	No treatment control
Behavioral Therapy	Behavioral Therapy	Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
Behavioral Therapy Plus Technologies	Behavioral Therapy	Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
Behavioral Therapy Plus Technologies	Pelvic Floor Electrical Stimulation	Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
Behavioral Therapy Plus Technologies	Biofeedback	Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)

Primary Outcome Measures

Name	Time	Method
Percent Change in Incontinence Episodes on Bladder Diary	2 months	\[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes\] x 100%
Percent Change in Incontinence Episodes Per Week on Bladder Diary	1 year	\[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes\] x 100%

Secondary Outcome Measures