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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Urinary Stress Incontinence

Intervention / Treatment
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* Drug: Duloxetine
* Procedure: Pelvic Floor Muscle Training (PFMT)
* Procedure: Imitation PFMT
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine|nan|
|Procedure: Pelvic Floor Muscle Training (PFMT)|nan|
|Procedure: Imitation PFMT|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |