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

This study is currently recruiting patients.
Verified by Pfizer September 2005

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00143481

Purpose

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.
Condition Intervention Phase
Urinary Incontinence
 Drug: Tolterodine ER 4mg QD
Phase IV

MedlinePlus related topics:  Urinary Incontinence

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Life and Sexual Function in Women With Overactive Bladder

Further Study Details: 
Primary Outcomes: Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
Secondary Outcomes: Information was omitted due to their commercial sensitivity, and will be revealed at a later date.; 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 ur
Expected Total Enrollment:  400

Study start: March 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female
Criteria

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)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00143481

Pfizer CT.gov Call Center      1-800-718-1021 

Arkansas
      Pfizer Investigational Site, Little Rock,  Arkansas,  72205,  United States; Recruiting

California
      Pfizer Investigational Site, Santa Rosa,  California,  95405,  United States; Recruiting

      Pfizer Investigational Site, San Francisco,  California,  94102,  United States; Recruiting

      Pfizer Investigational Site, Berkeley,  California,  94705,  United States; Recruiting

      Pfizer Investigational Site, Oakland,  California,  94612,  United States; Recruiting

      Pfizer Investigational Site, San Diego,  California,  92108,  United States; Recruiting

Colorado
      Pfizer Investigational Site, Denver,  Colorado,  80204,  United States; Recruiting

      Pfizer Investigational Site, Denver,  Colorado,  80202,  United States; Recruiting

      Pfizer Investigational Site, Lakewood,  Colorado,  80228,  United States; Recruiting

Connecticut
      Pfizer Investigational Site, Farmington,  Connecticut,  06032,  United States; Recruiting

      Pfizer Investigational Site, West Hartford,  Connecticut,  06117,  United States; Recruiting

Florida
      Pfizer Investigational Site, Leesburg,  Florida,  34748,  United States; Recruiting

      Pfizer Investigational Site, Weston,  Florida,  33331,  United States; Recruiting

      Pfizer Investigational Site, Clearwater,  Florida,  33759,  United States; Recruiting

      Pfizer Investigational Site, West Palm Beach,  Florida,  33409-1972,  United States; Recruiting

Georgia
      Pfizer Investigational Site, Alpharetta,  Georgia,  30005,  United States; Recruiting

Indiana
      Pfizer Investigational Site, South Bend,  Indiana,  46601,  United States; Recruiting

      Pfizer Investigational Site, Evansville,  Indiana,  47714,  United States; Recruiting

      Pfizer Investigational Site, Newburgh,  Indiana,  47630,  United States; Recruiting

Louisiana
      Pfizer Investigational Site, Baton Rouge,  Louisiana,  70815,  United States; Recruiting

      Pfizer Investigational Site, Metairie,  Louisiana,  70002,  United States; Recruiting

      Pfizer Investigational Site, Metairie,  Louisiana,  70006,  United States; Recruiting

Missouri
      Pfizer Investigational Site, Creve Coeur,  Missouri,  63141,  United States; Recruiting

Nevada
      Pfizer Investigational Site, Las Vegas,  Nevada,  89109,  United States; Recruiting

      Pfizer Investigational Site, North Las Vegas,  Nevada,  89030,  United States; Recruiting

      Pfizer Investigational Site, Las Vegas,  Nevada,  89128,  United States; Recruiting

New Jersey
      Pfizer Investigational Site, New Brunswick,  New Jersey,  08901,  United States; Recruiting

New York
      Pfizer Investigational Site, Olean,  New York,  14760,  United States; No longer recruiting

North Carolina
      Pfizer Investigational Site, Winston Salem,  North Carolina,  27103,  United States; Recruiting

      Pfizer Investigational Site, New Bern,  North Carolina,  28562,  United States; Recruiting

Ohio
      Pfizer Investigational Site, Cleveland,  Ohio,  44122,  United States; Recruiting

      Pfizer Investigational Site, Columbus,  Ohio,  43213,  United States; Recruiting

      Pfizer Investigational Site, Cleveland,  Ohio,  44195,  United States; Recruiting

      Pfizer Investigational Site, Cincinnati,  Ohio,  45267,  United States; Recruiting

      Pfizer Investigational Site, Cincinnati,  Ohio,  45220,  United States; Recruiting

      Pfizer Investigational Site, Gallipolis,  Ohio,  45631,  United States; Recruiting

Pennsylvania
      Pfizer Investigational Site, Allentown,  Pennsylvania,  18104,  United States; Recruiting

      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19114,  United States; Recruiting

South Carolina
      Pfizer Investigational Site, Columbia,  South Carolina,  29201,  United States; Recruiting

Texas
      Pfizer Investigational Site, Austin,  Texas,  78705,  United States; Recruiting

      Pfizer Investigational Site, San Antonio,  Texas,  78229,  United States; Recruiting

      Pfizer Investigational Site, Conroe,  Texas,  77304,  United States; Recruiting

      Pfizer Investigational Site, Austin,  Texas,  78703,  United States; Recruiting

      Pfizer Investigational Site, Austin,  Texas,  78756,  United States; Recruiting

      Pfizer Investigational Site, Irving,  Texas,  75061,  United States; Recruiting

Utah
      Pfizer Investigational Site, Salt Lake City,  Utah,  841107,  United States; Recruiting

      Pfizer Investigational Site, Salt Lake City,  Utah,  84124,  United States; Recruiting

Washington
      Pfizer Investigational Site, Seattle,  Washington,  98105,  United States; Recruiting

West Virginia
      Pfizer Investigational Site, Morgantown,  West Virginia,  26505,  United States; Recruiting

      Pfizer Investigational Site, Morgantown,  West Virginia,  26506-9251,  United States; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A6121002
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00143481
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06



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