Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stress Urinary Incontinence
Intervention: Fesoterodine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the
treatment of the condition of stress urinary incontinence
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
Secondary outcome: Change From Baseline in Closing Urethral Pressure at Day 7Change From Baseline in Opening Urethral Elastance at Day 7 Change From Baseline in Closing Urethral Elastance at Day 7 Incontinence Episode Frequency Per 24 Hours Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours Stress Incontinence Episode Frequency Per 24 Hours Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours Urgency Urinary Incontinence Episode Frequency Per 24 Hours Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Glostrup Hospital, Glostrup 2600, Denmark
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2009
Last updated: July 20, 2011
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