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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

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The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence

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Detailed Description

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Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Fesoterodine

Intervention Type DRUG

Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods

Interventions

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Fesoterodine

Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods

Intervention Type DRUG

Other Intervention Names

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Toviaz

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No