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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-04-30

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

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Detailed Description

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Conditions

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Urinary Stress Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Duloxetine

Intervention Type DRUG

Pelvic Floor Muscle Training (PFMT)

Intervention Type PROCEDURE

Imitation PFMT

Intervention Type PROCEDURE

placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No