Status:
COMPLETED
Conservative Treatment of Postprostatectomy Incontinence
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Urinary Incontinence
Eligibility:
MALE
Phase:
NA
Brief 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 stu...
Detailed Description
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 prospe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00212264
Start Date
August 1 2003
End Date
August 1 2011
Last Update
April 11 2016
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294