Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Stress Incontinence
Intervention: Duloxetine (Drug); Pelvic Floor Muscle Training (PFMT) (Procedure); Imitation PFMT (Procedure); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company
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
Clinical Details
Official title: Efficacy and Safety of Duloxetine Compared With Placebo,Pelvic Floor Muscle Training, and Combined Duloxetine/Pelvic Floor Muscle Training in Subjects With Moderate to Sever Stress Urinary Incontinence
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Incontinence Quality of Life scores from baseline to endpoint.Patient Global Impression - Impression at endpoint. Symptoms Frequency & Bothersomeness. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
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 3435, Netherlands
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, Weston, Florida 33331, United States
Additional Information
Starting date: January 2002
Ending date: April 2006
Last updated: January 24, 2007
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