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

Sponsor:	Eli Lilly and Company
Collaborator:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00190606

Purpose

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	Intervention	Phase
Urinary Stress Incontinence	Drug: Duloxetine Procedure: Pelvic Floor Muscle Training (PFMT) Procedure: Imitation PFMT Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

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.

Estimated Enrollment:	200
Study Start Date:	January 2002
Estimated Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190606

Locations

United States, Florida
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
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, Netherlands, 3435

Sponsors and Collaborators

Eli Lilly and Company

Boehringer Ingelheim Pharmaceuticals

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00190606 History of Changes
Other Study ID Numbers:	2615, F1J-MC-SBAF
Study First Received:	September 12, 2005
Last Updated:	January 24, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012