Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence

Phase 2

Completed

• Conditions: Urinary Stress Incontinence

• Registration Number: NCT00190606
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle training with that of placebo in patients with moderate to severe stress urinary incontinence

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-04
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-24
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Female
• Between 18 and 75 years of age
• Confirmed pure genuine stress incontinence
• Have discrete episodes of incontinence
• Have pelvic organ prolapse of no greater than Stage II

Exclusion Criteria

• Positive urine culture at visit 1
• Had formal PFMT with instruction
• Use of MAOI or other excluded medications
• Use of any anti-incontinence device, vaginal pessaries or any medication prescribed for the treatment of urinary incontinence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effectiveness of combined duloxetine and PFMT with combined placebo and imitation PFMT in women with SUI as measured by percent change in Incontinence Episode Frequency from baseline to endpoint.
Effectiveness of combined duloxetine and PFMT with combined placebo and PFMT for up to 12 weeks in women with SUI as measured by percent change in Incontinence Episode Frequency from baseline to endpoint.

Secondary Outcome Measures

Name	Time	Method
Incontinence Quality of Life scores from baseline to endpoint.
Symptoms Frequency & Bothersomeness.
Patient Global Impression - Impression at endpoint.
Percent change in weekly continence pad usage (CPAD) from baseline to endpoint.
Change in Patient Satisfaction Questionnaires -2 and -4 questionnaire scores from baseline to endpoint.
Percent change in daily CPAD from baseline to endpoint.
Compare safety of duloxetine with placebo based on vital signs , laboratory values and the occurrence of treatment-emergent adverse events.
Compare combined duloxetine and PFMT, combined duloxetine and imitation PFMT, combined placebo with PFMT and combined placebo and imitation PFMTwith respect to efficacy and to safety.
Compare the effect of duloxetine and placebo on patient compliance to PFMT and imitation PFMT regimes using a daly patient-generated log of completed contractions.
Generate long-term safety data (during open-label extension) on duloxetine in the treatment of women with SUI.

Trial Locations

Locations (1)

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 - 5 hours, EST), or speak with your personal physician; 🇳🇱 Nieuwegein, Netherlands