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OpenTrials
Completed

NCT Number: NCT00190853

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

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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, Ljubljana, Slovenia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effect of Duloxetine on Valsalva Leak Point Pressure and Quantitative Rhabdosphincter Electromyography Measures in Women With Stress Urinary Incontinence

Important dates

Study start
2005
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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