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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 7

Change 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

Page last updated: August 23, 2015

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