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

NCT00143481 | Completed Phase 4

• 1 other identifier: A6121002
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 58

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline

• Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline

• Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline

• Reasons for treatment withdrawal

• Adverse Events during the 24 week treatment period.

Interventions

Tolterodine ER 4mg QD DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (58)

Pfizer Investigational Site

Chandler, Arizona, 85225, United States

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Phoenix, Arizona, 85013, United States

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Little Rock, Arkansas, 72205, United States

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Berkeley, California, 94705, United States

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Oakland, California, 94612, United States

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San Diego, California, 92108, United States

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San Francisco, California, 94102, United States

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Santa Rosa, California, 95405, United States

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Denver, Colorado, 80202, United States

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Denver, Colorado, 80204, United States

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Lakewood, Colorado, 80228, United States

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Farmington, Connecticut, 06032, United States

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West Hartford, Connecticut, 06117, United States

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Clearwater, Florida, 33759, United States

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Leesburg, Florida, 34748, United States

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Miami, Florida, 33145, United States

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Pembroke Pines, Florida, 33024, United States

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West Palm Beach, Florida, 33409-1972, United States

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Weston, Florida, 33331, United States

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Alpharetta, Georgia, 30005, United States

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Evansville, Indiana, 47714, United States

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Newburgh, Indiana, 47630, United States

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South Bend, Indiana, 46601, United States

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Baton Rouge, Louisiana, 70815, United States

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Metairie, Louisiana, 70002, United States

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Metairie, Louisiana, 70006, United States

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Baltimore, Maryland, 21211, United States

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Saginaw, Michigan, 48602, United States

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Creve Coeur, Missouri, 63141, United States

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Las Vegas, Nevada, 89109, United States

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Las Vegas, Nevada, 89128, United States

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North Las Vegas, Nevada, 89030, United States

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New Brunswick, New Jersey, 08901, United States

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Albuquerque, New Mexico, 87131-0001, United States

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Olean, New York, 14760, United States

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New Bern, North Carolina, 28562, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45220, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44122, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43213, United States

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Gallipolis, Ohio, 45631, United States

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Allentown, Pennsylvania, 18104, United States

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Philadelphia, Pennsylvania, 19114, United States

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Columbia, South Carolina, 29201, United States

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Austin, Texas, 78703, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78756, United States

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Bryan, Texas, 77802-1903, United States

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Conroe, Texas, 77304, United States

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Irving, Texas, 75061, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84107, United States

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Salt Lake City, Utah, 84124, United States

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Seattle, Washington, 98105, United States

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Morgantown, West Virginia, 26505, United States

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Pfizer Investigational Site

Morgantown, West Virginia, 26506-9251, United States

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Related Publications (3)

• 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.

  PMID: 37160401 DERIVED

• 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.

  PMID: 19601704 DERIVED

• 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.

  PMID: 18685795 DERIVED

Related Links

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

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: March 1, 2005
• Primary Completion: June 1, 2006
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (58)