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

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Chandler, Arizona, 85225 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urinary Incontinence
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT00143481
Pfizer
Completed
Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women

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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
Intervention Model: Parallel Assignment
Masking: Double
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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00143481
A6121002
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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