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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00190606

Collaborator

Boehringer Ingelheim (Industry)

200

Enrollment

Locations

Duration (Months)

100

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Stress Incontinence	Drug: Duloxetine Procedure: Pelvic Floor Muscle Training (PFMT) Procedure: Imitation PFMT Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2002

Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	Weston	Florida	United States	33331
2	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	3435

Sponsors and Collaborators

Eli Lilly and Company
Boehringer Ingelheim

Investigators

Study Director: 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), Eli Lilly and Company