Conservative Treatment of Postprostatectomy Incontinence

Completed · Not applicable · Has a placebo group

Conditions studied: Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT00212264

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

208

Starts

2003-08-01

Expected to finish

2011-08-01

Last updated by the study team

2016-04-11

Who can join

Age: any. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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