Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women

Phase 4

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT00143481
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2006-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• 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 Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.

Secondary Outcome Measures

Name	Time	Method
Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline
Reasons for treatment withdrawal
Adverse Events during the 24 week treatment period.
Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline
Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Morgantown, West Virginia, United States