Urinary Stress Incontinence
Conditions
Brief summary
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
Interventions
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
| Incontinence Quality of Life scores from baseline to endpoint. | — |
| 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. | — |
| Compare safety of duloxetine with placebo based on vital signs , laboratory values and the occurrence of treatment-emergent adverse events. | — |
| Patient Global Impression - Impression at endpoint. | — |
Countries
Netherlands, United States
Outcome results
None listed