Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress incontinence

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.

NCT00190814

Urinary Incontinence, Stress

COMPLETED PHASE3

Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

NCT00190827

Urinary Incontinence, Stress

COMPLETED PHASE3

Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

NCT00190996

Urinary Incontinence, Stress

COMPLETED PHASE3

Efficacy and Safety of Duloxetine

NCT00190619

Urinary Stress Incontinence

COMPLETED PHASE3

Duloxetine in the Treatment of Stress Urinary Incontinence.

NCT00191087

Urinary Incontinence, Stress

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Stress Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

duloxetine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female
* Between 18 and 75 years of age
* Diagnosis of GSI
* Have discrete episodes of incontinence

Exclusion Criteria

* Positive urine culture at visit 1
* Use of MAOI
* Have had continence or urethral surgery
* Use of anti-incontinence device, vaginal pessaries or medications for the treatment of urinary incontinence
* Began pelvic floor muscle exercises within 6 months prior to study entry.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No