N/A
N=208
Conservative Treatment of Postprostatectomy Incontinence
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00212264 ↗Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Percent Change in Incontinence Episodes on Bladder Diary — 55; 51; 24 % change in episodes per week — p=.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Therapy (Behavioral); Pelvic Floor Electrical Stimulation (Device); Biofeedback (Behavioral); No Treatment (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Sep 2008
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 |
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.
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.