Enhancing Conservative Treatment for Urge Incontinence
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Incontinence
Intervention: Oxybutynin chloride, extended-release, individually-titrated (Drug); Behavior Training (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s): Kathryn L. Burgio, PhD MA BA, Principal Investigator, Affiliation: Department of Veterans Affairs
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 than drug therapy alone for urge incontinence in community-dwelling women.
Clinical Details
Official title: Enhancing Conservative Treatment for Urge Incontinence
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Incontinent Episodes Immediately Post-treatment
Secondary outcome: Change in Incontinent Episodes at 12-month Follow-up
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 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.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
Participants in this study were 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.
Locations and Contacts
Birmingham VA Medical Center, Birmingham, Alabama 35233, United States
Additional Information
Starting date: September 2003
Last updated: October 29, 2013
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