Clinical trial NCT00190567: Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence
Official title: Biomechanical Effects of Duloxetine on Bladder Function and Sphincter Resistance During the Emptying Phase and on Urethral Function During the Filling Phase of the Micturition Cycle in Women With Pure Genuine Stress Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Stress Incontinence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2005-09-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress incontinence


Eligibility criteria: Inclusion Criteria:

* Female
* Between 18 and 75 years of age
* Diagnosis of GSI
* Have discrete episodes of incontinence

Exclusion Criteria:

* Positive urine culture at visit 1
* Use of MAOI
* Have had continence or urethral surgery
* Use of anti-incontinence device, vaginal pessaries or medications for the treatment of urinary incontinence
* Began pelvic floor muscle exercises within 6 months prior to study entry.

Primary outcomes:
measure: Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure
Secondary outcomes:
measure: Compare the effects of duloxetine with that of placebo on measures of bladder emptying phase function derived from
measure: non-instrumented and instrumented uroflowmetry studies
measure: Percent change in Incontinent Episode Frequency (IEF) from baseline to endpoint
measure: Subject-perceived improvement in their GSI as measured by the Patient Global Impressions-Improvement (PGI-I) questionnaire at endpoint
measure: Compare duloxetine responders with duloxetine non-responders with respect to:
measure: Baseline measures of urethral function
measure: Outcome measures of urethral function
measure: Outcome measures of emptying function
measure: Vital signs, laboratory values and the occurrence of treatment-emergent adverse events
measure: In the open-label extension:
measure: Determine the effects of duloxetine six to seven months after initiation on measures of urethral function
measure: Collect long-term data on the maintenance of effect of duloxetine in the treatment of GSI as measured by IEF, PGI-I, vital signs, laboratory values and the occurrence of treatment-emergent adverse events.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon -Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: