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

NCT ID: NCT00143481

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tolterodine ER 4mg QD

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Chandler, Arizona, United States

Site Status

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Berkeley, California, United States

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Oakland, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Rosa, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Lakewood, Colorado, United States

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Farmington, Connecticut, United States

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West Hartford, Connecticut, United States

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Clearwater, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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West Palm Beach, Florida, United States

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Weston, Florida, United States

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Alpharetta, Georgia, United States

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Evansville, Indiana, United States

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Newburgh, Indiana, United States

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South Bend, Indiana, United States

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Baton Rouge, Louisiana, United States

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Metairie, Louisiana, United States

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Metairie, Louisiana, United States

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Baltimore, Maryland, United States

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Saginaw, Michigan, United States

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Creve Coeur, Missouri, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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North Las Vegas, Nevada, United States

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New Brunswick, New Jersey, United States

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Albuquerque, New Mexico, United States

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Olean, New York, United States

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New Bern, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Gallipolis, Ohio, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Bryan, Texas, United States

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Conroe, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Seattle, Washington, United States

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Morgantown, West Virginia, United States

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Pfizer Investigational Site

Morgantown, West Virginia, United States

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Countries

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United States

References

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Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

Reference Type DERIVED
PMID: 37160401 (View on PubMed)

Rogers RG, Bachmann G, Scarpero H, Jumadilova Z, Sun F, Morrow JD, Guan Z, Bavendam T. Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence. Curr Med Res Opin. 2009 Sep;25(9):2159-65. doi: 10.1185/03007990903103279.

Reference Type DERIVED
PMID: 19601704 (View on PubMed)

Rogers R, Bachmann G, Jumadilova Z, Sun F, Morrow JD, Guan Z, Bavendam T. Efficacy of tolterodine on overactive bladder symptoms and sexual and emotional quality of life in sexually active women. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1551-7. doi: 10.1007/s00192-008-0688-6. Epub 2008 Aug 7.

Reference Type DERIVED
PMID: 18685795 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6121002&StudyName=Effect+of+Detrol+LA+on+Overactive+Bladder+Symptoms%2C+Sexual+Quality+of+Life+and+Sexual+Function+in+Women

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6121002

Identifier Type: -

Identifier Source: org_study_id

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