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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143481
First received: September 1, 2005
Last updated: April 9, 2013
Last verified: April 2013
History of Changes

September 1, 2005
April 9, 2013
March 2005
June 2006   (final data collection date for primary outcome measure)
Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
Same as current
Complete list of historical versions of study NCT00143481 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Not Provided
Not Provided
 
Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Urinary Incontinence
Drug: Tolterodine ER 4mg QD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
Not Provided
June 2006   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00143481
A6121002
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP