Official Title: “Enhancing Conservative Treatment for Urge Incontinence”

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 than drug therapy alone for urge incontinence in community-dwelling women.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2008

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 demonstrated that behavioral and drug interventions are effective, but do not cure most patients. Thus there is a need to improve conservative treatment for urge incontinence in women. 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 than drug therapy alone for urge incontinence in community-dwelling women.

This project is a randomized controlled clinical trial. Sixty-four women with predominantly urge incontinence have been randomized. Stratification and blocked randomization procedures are used to assign a subject to 8 weeks of drug therapy alone or 8 weeks of drug therapy enhanced with components of behavioral training that can be administered in most any outpatient clinic. The drug therapy is extended release oxybutynin, a well-established pharmacologic agent with a state of the art drug delivery system that has the lowest rates of side-effect. The behavioral treatment is an innovative, comprehensive, behavioral training program, which includes pelvic floor muscle rehabilitation, teaching urge suppression and other skills to improve bladder control, and self-monitoring with bladder diaries. Bladder diaries completed by subjects before and after the treatment are used to calculate reduction in the frequency of incontinence. Secondary outcomes measures include a patient satisfaction questionnaire and three impact/quality of life measures (Incontinence Impact Questionnaire, Uro-Genital Distress Index, SF-12 Health Survey). The second objective of the study is to examine the cost-effectiveness of adding behavioral components to drug therapy. With the changing health care environment, there is increased concern with the costs of providing treatment. This project will compare the relative costs and value of combined intervention using the methods of cost-effectiveness analysis, the most widely adopted method for the economic evaluation of health interventions. The third objective of the study is to examine further the mechanisms by which these therapies reduce incontinence, including changes in bladder capacity, thresholds for bladder sensation, pelvic muscle strength, use of pelvic muscles in response to the sensation of urgency and frequency of urination.

Pre-post changes in these parameters are measured to examine the effects of the treatment on these variables, and structural equation modeling will be used to examine whether changes in each of these measures are related to treatment outcome.

Intervention(s) in this Clinical Trial

• Drug: Extended release Oxybutynin Chloride
  • Individually-titrated, extended release oxybutynin chloride with management of side-effects.
• Behavioral: Behavior Training
  • Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.
• Drug: Extended release Oxybutynin Chloride
  • Individually-titrated, extended release oxybutynin chloride with management of side-effects.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • drug therapy alone
• Experimental: 2
  • drug therapy + behavioral training

Primary Measures

• Reduction in frequency of incontinent episodes
  • Time Frame: 8 weeks, 6 months, and 12 months
    Safety Issue?: No

Inclusion Criteria:

• Participants in this study are ambulatory, community-dwelling women (veterans and nonveterans) with persistent urge or predominantly urge incontinence.

Participants must:

• 1. Be ambulatory.
• 2. Be able to come to the clinic for treatment.
• 3. Report urge incontinence.
• 4. Report incontinence occurring at least twice per week on average.
• 5. Report incontinence persisting for at least three months.
• 6. Not have received behavioral therapy in the University of Alabama at Birmingham (UAB)
• Continence Clinic or Department of Veterans Affairs (VA) Continence Clinic.
• 7. 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.
• 8. 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.
• 9. On urodynamic evaluation, there must be cystometric evidence of bladder dysfunction, either: detrusor instability or maximal cystometric capacity is less than 400 ml.

Exclusion Criteria:

• 1. Continual leakage.
• 2. Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture).
• 3. Fecal impaction.
• 4. Uncontrolled metabolic problem.
• 5. Post-void residual volume > 150 ml.
• 6. 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.
• 7. Severe uterine prolapse (prolapse reaching the vaginal introitus).
• 8. Decompensated congestive heart failure, diagnosed by history or physical exam.
• 9. Impaired mental status. (<24 on Folstein's Mini-Mental State Exam).
• 10. Uncontrolled narrow angle glaucoma.
• 11. Gastric retention (by medical history).
• 12. Hypersensitivity to oxybutynin.
• 13. 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.
• 14. If on diuretic, dose stable for less than three months.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Department of Veterans Affairs

Overall Clinical Trial Officials and Contacts

Kathryn L. Burgio, PhD MA BA Principal Investigator Brimingham VA Medical Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00223821

Study ID Number: B2899R

ClinicalTrials.gov Identifier: NCT00223821

Health Authority: United States: Federal Government