Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women
NCT00143481
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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)
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Descriptive Information | ||||
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Brief Title ICMJE | Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women | |||
Official Title ICMJE | 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 | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Urinary Incontinence | |||
Intervention ICMJE | Drug: Tolterodine ER 4mg QD | |||
Study Arms ICMJE | Not Provided | |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 400 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | June 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00143481 | |||
Other Study ID Numbers ICMJE | A6121002 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |