Clinical trial NCT01042236: Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Keywords: Phase 2 stress urinary incontinence Fesoterodine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-05
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
timeFrame: Baseline, Day 7 of each period
Secondary outcomes:
measure: Change From Baseline in Closing Urethral Pressure at Day 7
timeFrame: Baseline, Day 7 of each period
measure: Change From Baseline in Opening Urethral Elastance at Day 7
timeFrame: Baseline, Day 7 of each period
measure: Change From Baseline in Closing Urethral Elastance at Day 7
timeFrame: Baseline, Day 7 of each period
measure: Incontinence Episode Frequency Per 24 Hours
timeFrame: Baseline, Day 7 of each period
measure: Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours
timeFrame: Baseline, Day 7 of each period
measure: Stress Incontinence Episode Frequency Per 24 Hours
timeFrame: Baseline, Day 7 of each period
measure: Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours
timeFrame: Baseline, Day 7 of each period
measure: Urgency Urinary Incontinence Episode Frequency Per 24 Hours
timeFrame: Baseline, Day 7 of each period
measure: Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours
timeFrame: Baseline, Day 7 of each period
measure: Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration
timeFrame: Baseline, Day 7 of each period
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.