Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients

Back to Search
Print
Bookmark Trial

NCT01042236

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Glostrup Hospital
Glostrup, , 2600, Denmark
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stress Urinary Incontinence
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Female, 18 - 65 years

- SUI symptoms for longer than 3 months

- Subjects must be non-pregnant and not breastfeeding

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


- Disease or medical condition affecting the bladder or urinary tract (other tan stress
urinary incontinence)


- Subjects taking medication with effects on the bladder or urinary tract


- Subejcts with medical conditions which could be adversely affected by administration
of fesoterodine - gastrointestinal tract disease, glaucoma, hepatic impairment

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Stress Urinary IncontinenceEvaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
NCT01042236
  1. Glostrup,
Female
18 Years+
years
MULTIPLE SITES
Stress Urinary IncontinenceEvaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.
NCT00141128
  1. Glostrup,
Female
18 Years+
years
MULTIPLE SITES
Stress Urinary IncontinenceAn 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
NCT00138749
  1. Anchorage, Alaska
  2. Sun City, Arizona
  3. Tucson, Arizona
  4. Tucson, Arizona
  5. Little Rock, Arkansas
  6. Atherton, California
  7. Carmichael, California
  8. Laguna Woods, California
  9. Murrieta, California
  10. Newport Beach, California
  11. Sacramento, California
  12. San Diego, California
  13. Tarzana, California
  14. Temecula, California
  15. Torrance, California
  16. Vista, California
  17. Aurora, Colorado
  18. Denver, Colorado
  19. Denver, Colorado
  20. Wheat Ridge, Colorado
  21. New London, Connecticut
  22. Waterbury, Connecticut
  23. Aventura, Florida
  24. New Port Richey, Florida
  25. Panama City, Florida
  26. Panama City, Florida
  27. Pembroke Pines, Florida
  28. Port Richey, Florida
  29. West Palm Beach, Florida
  30. Alpharetta, Georgia
  31. Coeur D Alene, Idaho
  32. Arlington Heights, Illinois
  33. Chicago, Illinois
  34. Melrose Park, Illinois
  35. Greenwood, Indiana
  36. Indianapolis, Indiana
  37. Des Moines, Iowa
  38. Louisville, Kentucky
  39. Shreveport, Louisiana
  40. Greenbelt, Maryland
  41. Watertown, Massachusetts
  42. Jackson, Mississippi
  43. Jackson, Mississippi
  44. Liberty, Missouri
  45. North Kansas City, Missouri
  46. Omaha, Nebraska
  47. Henderson, Nevada
  48. Edison, New Jersey
  49. West Orange, New Jersey
  50. Albuquerque, New Mexico
  51. Albany, New York
  52. Garden City, New York
  53. Garden City, New York
  54. Mineola, New York
  55. Poughkeepsie, New York
  56. Burlington, North Carolina
  57. Charlotte, North Carolina
  58. Concord, North Carolina
  59. Fayetteville, North Carolina
  60. Winston-salem, North Carolina
  61. Cincinnati, Ohio
  62. Bethany, Oklahoma
  63. Eugene, Oregon
  64. Eugene, Oregon
  65. Medford, Oregon
  66. Portland, Oregon
  67. Colmar, Pennsylvania
  68. Lancaster, Pennsylvania
  69. Philadelphia, Pennsylvania
  70. Pittsburgh, Pennsylvania
  71. Sellersville, Pennsylvania
  72. Sewickley, Pennsylvania
  73. Providence, Rhode Island
  74. Charleston, South Carolina
  75. Columbia, South Carolina
  76. Greer, South Carolina
  77. Myrtle Beach, South Carolina
  78. Knoxville, Tennessee
  79. Knoxville, Tennessee
  80. Corpus Christi, Texas
  81. Corsicana, Texas
  82. Houston, Texas
  83. San Antonio, Texas
  84. Salt Lake City, Utah
  85. Sandy, Utah
  86. Sandy, Utah
  87. West Jordan, Utah
  88. Virginia Beach, Virginia
  89. Seattle, Washington
  90. Surrey, British Columbia
  91. Victoria, British Columbia
  92. Kitchener, Ontario
  93. Oakville, Ontario
  94. Montreal, Quebec
  95. Pointe-Claire, Quebec
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Crossover Study Of The Efficacy Of Fesoterodine In Increasing Urethral Pressure In Stress Urinary Incontinence Patients.
Brief Summary The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE Drug: Fesoterodine
Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods
Other Name: Toviaz
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Fesoterodine
Publications * Klarskov N, Darekar A, Scholfield D, Whelan L, Lose G. Effect of fesoterodine on urethral closure function in women with stress urinary incontinence assessed by urethral pressure reflectometry. Int Urogynecol J. 2014 Jun;25(6):755-60. doi: 10.1007/s00192-013-2269-6. Epub 2013 Nov 21.

*   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
Actual Enrollment  ICMJE
 (submitted: August 10, 2010)		22
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2010)		18
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female, 18 - 65 years
  • SUI symptoms for longer than 3 months
  • Subjects must be non-pregnant and not breastfeeding

Exclusion Criteria:

  • Disease or medical condition affecting the bladder or urinary tract (other tan stress urinary incontinence)
  • Subjects taking medication with effects on the bladder or urinary tract
  • Subejcts with medical conditions which could be adversely affected by administration of fesoterodine - gastrointestinal tract disease, glaucoma, hepatic impairment
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 65 Years   (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 Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01042236
Other Study ID Numbers  ICMJE A0221064
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2011

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