Clinical trial · Interventional
Conservative Treatment of Postprostatectomy Incontinence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Therapy | Behavioral | — | UNRESOLVED |
| Biofeedback | Behavioral | — | UNRESOLVED |
| No Treatment | Other | — | UNRESOLVED |
| Pelvic Floor Electrical Stimulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Behavioral Therapy
- description
- Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
- interventionNames
- Behavioral: Behavioral Therapy
- type
- EXPERIMENTAL
- label
- Behavioral Therapy Plus Technologies
- description
- Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
- interventionNames
- Behavioral: Behavioral Therapy
- Device: Pelvic Floor Electrical Stimulation
- Behavioral: Biofeedback
- type
- PLACEBO_COMPARATOR
- label
- Placebo Comparator
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (2)
- RESULTGoode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa MM, Lloyd LK. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. 2011 Jan 12;305(2):151-9. doi: 10.1001/jama.2010.1972. PMID 21224456
- DERIVEDJohnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2. PMID 37070660