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

Urinary Stress Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190606
• Other study ID #: 2615
• Secondary ID: F1J-MC-SBAF
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: January 2002
• Est. completion date: April 2006

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Drug:
• Duloxetine

Procedure:
• Pelvic Floor Muscle Training (PFMT)

• Imitation PFMT

Drug:
• placebo

Locations

Country	Name	City	State
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	Nieuwegein
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Incontinence Quality of Life scores from baseline to endpoint.
Secondary	Patient Global Impression - Impression at endpoint.
Secondary	Symptoms Frequency & Bothersomeness.
Secondary	Percent change in weekly continence pad usage (CPAD) from baseline to endpoint.
Secondary	Change in Patient Satisfaction Questionnaires -2 and -4 questionnaire scores from baseline to endpoint.
Secondary	Percent change in daily CPAD from baseline to endpoint.
Secondary	Compare safety of duloxetine with placebo based on vital signs , laboratory values and the occurrence of treatment-emergent adverse events.
Secondary	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.
Secondary	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.
Secondary	Generate long-term safety data (during open-label extension) on duloxetine in the treatment of women with SUI.