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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolterodine ER 4mg QD | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Chandler | Arizona | 85225 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37160401 | Derived | 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. | |
| 19601704 | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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. |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Pfizer Investigational Site | Berkeley | California | 94705 | United States |
| Pfizer Investigational Site | Oakland | California | 94612 | United States |
| Pfizer Investigational Site | San Diego | California | 92108 | United States |
| Pfizer Investigational Site | San Francisco | California | 94102 | United States |
| Pfizer Investigational Site | Santa Rosa | California | 95405 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80202 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80204 | United States |
| Pfizer Investigational Site | Lakewood | Colorado | 80228 | United States |
| Pfizer Investigational Site | Farmington | Connecticut | 06032 | United States |
| Pfizer Investigational Site | West Hartford | Connecticut | 06117 | United States |
| Pfizer Investigational Site | Clearwater | Florida | 33759 | United States |
| Pfizer Investigational Site | Leesburg | Florida | 34748 | United States |
| Pfizer Investigational Site | Miami | Florida | 33145 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33409-1972 | United States |
| Pfizer Investigational Site | Weston | Florida | 33331 | United States |
| Pfizer Investigational Site | Alpharetta | Georgia | 30005 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47714 | United States |
| Pfizer Investigational Site | Newburgh | Indiana | 47630 | United States |
| Pfizer Investigational Site | South Bend | Indiana | 46601 | United States |
| Pfizer Investigational Site | Baton Rouge | Louisiana | 70815 | United States |
| Pfizer Investigational Site | Metairie | Louisiana | 70002 | United States |
| Pfizer Investigational Site | Metairie | Louisiana | 70006 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21211 | United States |
| Pfizer Investigational Site | Saginaw | Michigan | 48602 | United States |
| Pfizer Investigational Site | Creve Coeur | Missouri | 63141 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89109 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89128 | United States |
| Pfizer Investigational Site | North Las Vegas | Nevada | 89030 | United States |
| Pfizer Investigational Site | New Brunswick | New Jersey | 08901 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87131-0001 | United States |
| Pfizer Investigational Site | Olean | New York | 14760 | United States |
| Pfizer Investigational Site | New Bern | North Carolina | 28562 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45220 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45267 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44122 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44195 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43213 | United States |
| Pfizer Investigational Site | Gallipolis | Ohio | 45631 | United States |
| Pfizer Investigational Site | Allentown | Pennsylvania | 18104 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29201 | United States |
| Pfizer Investigational Site | Austin | Texas | 78703 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Austin | Texas | 78756 | United States |
| Pfizer Investigational Site | Bryan | Texas | 77802-1903 | United States |
| Pfizer Investigational Site | Conroe | Texas | 77304 | United States |
| Pfizer Investigational Site | Irving | Texas | 75061 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84124 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98105 | United States |
| Pfizer Investigational Site | Morgantown | West Virginia | 26505 | United States |
| Pfizer Investigational Site | Morgantown | West Virginia | 26506-9251 | United States |
| 18685795 | 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. |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
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