Status:
COMPLETED
Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.
Eligibility Criteria
Inclusion
- Female outpatients 18 years or older.
- Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
- Currently sexually active with a male partner.
Exclusion
- Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
- Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
- Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
- Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00143481
Start Date
March 1 2005
Last Update
January 27 2021
Active Locations (58)
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1
Pfizer Investigational Site
Chandler, Arizona, United States, 85225
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
3
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
4
Pfizer Investigational Site
Berkeley, California, United States, 94705