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Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190827
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
  Purpose

The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.


Condition Intervention Phase
Urinary Incontinence, Stress
Drug: duloxetine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effectiveness of Duloxetine Compared With Placebo in the Treatment of Predominant Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Compare duloxetine 40 mg BID with placebo in the reduction of incontinence episode frequency(IEF). Study visits occur every two weeks in therapy phase.
  • Evaluate the effects of different regimens of dose escalation and tapering effects on incidence of most prevalent adverse events.

Secondary Outcome Measures:
  • Assessment of overall patient safety.
  • Reduction of IEFs using standardized instruments.

Estimated Enrollment: 500
Study Start Date: September 2003
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female outpatients > or = 18 years of age
  • experience episodes of stress urinary incontinence
  • must have an educational level and degree of understanding English
  • are free of urinary tract infections
  • can use the toilet independently

Exclusion Criteria:

  • any in or outpatient surgery in the last six months
  • suffer from severe constipation
  • extension of any internal organs beyond vaginal opening
  • currently breastfeeding
  • any nervous diseases affecting normal urinary function
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190827

Locations
Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician
Rio De Janeiro, Brazil, 20551-030
Canada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician
Quebec, Canada, Quebec G1S 2L6
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician
Paris, France, 75651
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician
Mainz, Germany, 55131
Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician
Torino, Italy, 10133
Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician
Mexico City, Mexico, 6700
Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician
San Juan, Puerto Rico, PR 00912
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY(1-877-285-4559 OR 1-317-615-4559) Mon-Fri from 9am to 5pm Eastern time(UTC/GMT - 5 hours, EST) or speak with your personal physician
Barcelona, Spain, 8036
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) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00190827     History of Changes
Other Study ID Numbers: 6195, F1J-MC-SBBR
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
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014