Biomechanical and Electrophysiological Effects of Duloxetine in the Treatment of Women With Urinary Stress Incontinence

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190853
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
  Purpose

Biomechanical and electrophysiological effects of duloxetine in the treatment of women with urinary stress incontinence


Condition Intervention Phase
Urinary Stress Incontinence
Drug: Duloxetine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Duloxetine on Valsalva Leak Point Pressure and Quantitative Rhabdosphincter Electromyography Measures in Women With Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Assess the effects of duloxetine in women with urodynamically proved stress urinary incontinence on the within-group change in vesical Valsalva leak point pressure (VLPP) from baseline to endpoint.

Secondary Outcome Measures:
  • To evaluate the within-group endpoint/baseline ratios of Root Mean Square Voltage and Mean Rectified Voltage from the rhabdosphincter electromyogram (EMG) at rest and with coughing, and the ratio of cough/rest ratios from baseline to endpoint.
  • To evaluate the within-group changes in VLPP and ratios of EMG variables from baseline to 6 months and from 4 weeks to 6 months.
  • To describe the percent change in incontinence episode frequency (IEF) from baseline to post-baseline and define two groups, responders and non-responders, based on threshold value of < 50% IEF reduction values.
  • To compare the changes in VLPP and EMG ratios from baseline to 4 weeks and from baseline to 6 months in responder and non responders
  • To evaluate the safety and tolerability of duloxetine for up to 28 weeks in subjects diagnosed with urodynamic stress incontinence.Based on treatment-emergent adverse events, discontinuation rates, vital signs, and laboratory analyses

Estimated Enrollment: 93
Study Start Date: January 2005
Estimated Study Completion Date: September 2006
  Eligibility

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

Inclusion Criteria:

  • Have a diagnosis of only stress urinary incontinence
  • Have no pelvic organ prolapse protruding more than 1 cm beyond the hymen

Exclusion Criteria:

  • At visit 1, have a positive urine culture or a history of four or more urinary tract infections in the preceding year.
  • Have had more than one continence surgery.
  • Have a current or past urogenital cancer.
  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: NCT00190853

Locations
United States, Alabama
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Birmingham, Alabama, United States
United States, Colorado
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Denver, Colorado, United States
United States, Florida
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West Palm Beach, Florida, United States
United States, Illinois
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Oak Lawn, Illinois, United States
United States, Indiana
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Jeffersonville, Indiana, United States
United States, Louisiana
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Metairie, Louisiana, United States
United States, North Carolina
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Durham, North Carolina, United States
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Morganton, North Carolina, United States
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New Bern, North Carolina, United States
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Winston Salem, North Carolina, United States
United States, Tennessee
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
United States, Utah
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Salt Lake City, Utah, United States
United States, Virginia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Annandale, Virginia, United States
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Richmond, Virginia, United States
Slovenia
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Ljubljana, Slovenia
United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Manchester, United Kingdom
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM – 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00190853     History of Changes
Other Study ID Numbers: 9587, F1J-MC-SBCT
Study First Received: September 12, 2005
Last Updated: January 24, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Incontinence
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 October 23, 2014