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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00223821 |
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Date of registration:
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14/09/2005 |
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Primary sponsor: |
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Public title:
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Enhancing Conservative Treatment for Urge Incontinence
COMBO |
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Scientific title:
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Enhancing Conservative Treatment for Urge Incontinence |
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Date of first enrolment:
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September 2003 |
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Target sample size:
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166 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00223821 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Kathryn L. Burgio, PhD MA BA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Veterans Affairs |
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Key inclusion & exclusion criteria
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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.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Urinary Incontinence
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Intervention(s)
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Behavioral: Behavior Training
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Drug: Extended release Oxybutynin Chloride
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Primary Outcome(s)
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Reduction in frequency of incontinent episodes
[Time Frame: 8 weeks, 6 months, and 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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