Conservative Treatment of Postprostatectomy Incontinence
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Urinary Incontinence |
Behavioral: Behavioral Therapy Device: Pelvic Floor Electrical Stimulation Behavioral: Biofeedback Behavioral: Self Monitoring with Bladder Diaries |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Conservative Treatment of Postprostatectomy Incontinence |
- Frequency of incontinence episodes on bladder diary 24-hour pad test [ Time Frame: 2 months and 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 208 |
| Study Start Date: | August 2003 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
|
Behavioral: Behavioral Therapy
Pelvic Floor Muscle Exercises and Bladder control strategies
Behavioral: Self Monitoring with Bladder Diaries
Self Monitoring with Bladder Diaries
|
|
Experimental: 2
Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
|
Behavioral: Behavioral Therapy
Pelvic Floor Muscle Exercises and Bladder control strategies
Device: Pelvic Floor Electrical Stimulation
Pelvic Floor Electrical Stimulation daily for 8 weeks
Behavioral: Biofeedback
Pelvic Floor Muscle training via biofeedback
Behavioral: Self Monitoring with Bladder Diaries
Self Monitoring with Bladder Diaries
|
|
Placebo Comparator: 3
No treatment control
|
Behavioral: Self Monitoring with Bladder Diaries
Self Monitoring with Bladder Diaries
|
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Patricia S Goode, MD | University of Alabama at Birmingham |
More Information
Publications:
| Responsible Party: | Patricia Goode, Principal Investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00212264 History of Changes |
| Other Study ID Numbers: | DK60044 (completed) |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
urinary incontinence therapy prostatectomy prostate cancer |
Additional relevant MeSH terms:
|
Urinary Incontinence Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013