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	Behavior: Behavioral Training  Device: Biofeedback  Device: Pelvic Floor Electrical Stimulation  Behavior: Pelvic Floor Muscle Exercise

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures: 

• Frequency of incontinence episodes on bladder diary 24-hour pad test

Total Enrollment:  200

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 sequelea 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 incontinece.

Genders Eligible for Study:  Male

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. Involuntary loss of urine that started immediately after radical prostatectomy and has persisted for at least one year.
2. One-week bladder diary with interpretable data and at least two incontinence episodes

Exclusion Criteria:

1. Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina
2. Cardiac pacemaker or implanted cardiac defibrillator
3. Current use of anticholinergic agents for detrusor instability
4. Folstein's Mini-Mental State Exam score below 24 (impaired mental status)
5. One-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents.
6. Poorly controlled diabetes, defined as (glycosylated hemoglobin > 9 within last 3 months).
7. Hematuria on microscopic examination. Enrollment will be permitted after urologic evaluation.
8. Urodynamic evaluation: Post-void residual volume greater than 200 mL

Please refer to this study by ClinicalTrials.gov identifier  NCT00212264

Aline Ferner, RN      205-934-3259    lferner@uabmc.edu
Patricia S Goode, MD      205-934-3259    pgoode@uab.edu

Study chairs or principal investigators

Patricia S Goode, MD,  Principal Investigator,  University of Alabama at Birmingham   

Study ID Numbers:  DK60044
Last Updated:  March 13, 2007
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00212264
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on May 08, 2007