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OpenTrials
Completed

NCT Number: NCT00190606

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

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

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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 2

Primary 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, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Duloxetine

Drug

Pelvic Floor Muscle Training (PFMT)

Procedure

Imitation PFMT

Procedure

Placebo

Drug

Primary outcomes

  1. 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.

  2. 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

  1. Incontinence Quality of Life scores from baseline to endpoint.

  2. Patient Global Impression - Impression at endpoint.

  3. Symptoms Frequency & Bothersomeness.

  4. Percent change in weekly continence pad usage (CPAD) from baseline to endpoint.

  5. Change in Patient Satisfaction Questionnaires -2 and -4 questionnaire scores from baseline to endpoint.

  6. Percent change in daily CPAD from baseline to endpoint.

  7. Compare safety of duloxetine with placebo based on vital signs , laboratory values and the occurrence of treatment-emergent adverse events.

  8. 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.

  9. 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.

  10. Generate long-term safety data (during open-label extension) on duloxetine in the treatment of women with SUI.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study 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

Important dates

Study start
2002
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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