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

NCT00190606 | Completed Phase 2

• 2 other identifiers: 2615F1J-MC-SBAF
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

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

Conditions

Urinary Stress Incontinence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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.

Interventions

Duloxetine DRUG

Pelvic Floor Muscle Training (PFMT) PROCEDURE

Imitation PFMT PROCEDURE

placebo DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Boehringer Ingelheim: collaborator

Study Sites (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

Weston, Florida, 33331, United States

Location

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

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: January 1, 2002
• Study Completion: April 1, 2006
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

US (1); NL (1)