Status:
COMPLETED
Enhancing Conservative Treatment for Urge Incontinence
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes tha...
Detailed Description
Urinary incontinence in women is a major problem with significant medical, psychological, and social consequences. Previous research on urge incontinence, a common form of incontinence, has demonstrat...
Eligibility Criteria
Inclusion
- Participants in this study were ambulatory, community-dwelling women (veterans and nonveterans) with persistent urge or predominantly urge incontinence.
- Participants must:
- Be ambulatory.
- Be able to come to the clinic for treatment.
- Report urge incontinence.
- Report incontinence occurring at least twice per week on average.
- Report incontinence persisting for at least three months.
- Not have received behavioral therapy in the University of Alabama at Birmingham (UAB) Continence Clinic or Department of Veterans Affairs (VA) Continence Clinic.
- In the clinical interview, the subject must report involuntary loss of urine associated with a strong desire to void and that the condition has persisted for at least three months.
- At least two urge accidents on the 7-day baseline bladder diary, and the number of urge accidents must exceed the number of other types of accidents.
- On urodynamic evaluation, there must be cystometric evidence of bladder dysfunction, either: detrusor instability or maximal cystometric capacity is less than 400 ml.
Exclusion
- Continual leakage.
- Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture).
- Fecal impaction.
- Uncontrolled metabolic problem.
- Post-void residual volume \> 150 ml.
- Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended and enrollment will depend on agreement between the urologist and geriatrician (co-PI) that entry into treatment protocol is not contraindicated.
- Severe uterine prolapse (prolapse reaching the vaginal introitus).
- Decompensated congestive heart failure, diagnosed by history or physical exam.
- Impaired mental status. (\<24 on Folstein's Mini-Mental State Exam).
- Uncontrolled narrow angle glaucoma.
- Gastric retention (by medical history).
- Hypersensitivity to oxybutynin.
- Current use of anticholinergic agents for detrusor instability. Subjects on these medications will be asked to discontinue them for the duration of the study. Evaluation will be delayed until the drug(s) have been discontinued for 2 weeks.
- If on diuretic, dose stable for less than three months.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00223821
Start Date
September 1 2003
End Date
December 1 2009
Last Update
December 19 2013
Active Locations (1)
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1
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233