N/A
Completed N=208
Conservative Treatment of Postprostatectomy Incontinence
Source: ClinicalTrials.gov NCT00212264 ↗Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Percent Change in Incontinence Episodes on Bladder Diary — 55; 51; 24 % change in episodes per week — p=.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Incontinence Episodes on Bladder Diary |
55; 51; 24 | .001 sig |
| PRIMARY Percent Change in Incontinence Episodes Per Week on Bladder Diary |
50; 59 | .32 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00212264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.