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

NCT00143481

Last updated date
Study Location
Pfizer Investigational Site
Chandler, Arizona, 85225, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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)

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Urinary IncontinenceEffect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women
NCT00143481
  1. Chandler, Arizona
  2. Phoenix, Arizona
  3. Little Rock, Arkansas
  4. Berkeley, California
  5. Oakland, California
  6. San Diego, California
  7. San Francisco, California
  8. Santa Rosa, California
  9. Denver, Colorado
  10. Denver, Colorado
  11. Lakewood, Colorado
  12. Farmington, Connecticut
  13. West Hartford, Connecticut
  14. Clearwater, Florida
  15. Leesburg, Florida
  16. Miami, Florida
  17. Pembroke Pines, Florida
  18. West Palm Beach, Florida
  19. Weston, Florida
  20. Alpharetta, Georgia
  21. Evansville, Indiana
  22. Newburgh, Indiana
  23. South Bend, Indiana
  24. Baton Rouge, Louisiana
  25. Metairie, Louisiana
  26. Metairie, Louisiana
  27. Baltimore, Maryland
  28. Saginaw, Michigan
  29. Creve Coeur, Missouri
  30. Las Vegas, Nevada
  31. Las Vegas, Nevada
  32. North Las Vegas, Nevada
  33. New Brunswick, New Jersey
  34. Albuquerque, New Mexico
  35. Olean, New York
  36. New Bern, North Carolina
  37. Winston-Salem, North Carolina
  38. Cincinnati, Ohio
  39. Cincinnati, Ohio
  40. Cleveland, Ohio
  41. Cleveland, Ohio
  42. Columbus, Ohio
  43. Gallipolis, Ohio
  44. Allentown, Pennsylvania
  45. Philadelphia, Pennsylvania
  46. Columbia, South Carolina
  47. Austin, Texas
  48. Austin, Texas
  49. Austin, Texas
  50. Bryan, Texas
  51. Conroe, Texas
  52. Irving, Texas
  53. San Antonio, Texas
  54. Salt Lake City, Utah
  55. Salt Lake City, Utah
  56. Seattle, Washington
  57. Morgantown, West Virginia
  58. Morgantown, West Virginia
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
 (submitted: September 1, 2005)
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:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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
Study Director:Pfizer CT.gov Call CenterPfizer
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