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

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NCT01042236

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Glostrup Hospital
Glostrup, , 2600 Denmark
See other locations
Contact
1-800-718-1021
[email protected]
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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

NCT01042236
Pfizer
Completed
Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients

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Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
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.
The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Stress Urinary Incontinence
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
Experimental: Arm 1
Intervention: Drug: Fesoterodine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01042236
A0221064
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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