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

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190606
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 12, 2005
January 24, 2007
January 2002
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00190606 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Urinary Stress Incontinence
  • Drug: Duloxetine
  • Procedure: Pelvic Floor Muscle Training (PFMT)
  • Procedure: Imitation PFMT
  • Drug: placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2006
Not Provided

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
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands
 
NCT00190606
2615, F1J-MC-SBAF
Not Provided
Not Provided
Eli Lilly and Company
Boehringer Ingelheim
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
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP