Therapeutic Efficacy in Women With Stress Urinary Incontinence

Study Overview
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Brief Summary
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We will get the impact of duloxetine versus imipramine on therapeutic efficacy in women with SUI.

Detailed Description
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Background/Purpose: Pharmacologic treatments for female stress urinary incontinence (SUI) include duloxetine and imipramine. Duloxetine and Imipramine has been reported to have clinical significant therapeutic efficacy on female SUI and overactive bladder syndrome. However, there was no randomized controlled study to compare duloxetine and imipramine for the treatment of female SUI. Patients and Methods: We will perform a prospective randomized controlled study to recruit 90 female SUI patients at the Obstetrics & Gynecology outpatient clinic of Far Eastern Memorial Hospital. All SUI female patients will be asked to complete ICIQ-UI, USS, OABSS, and bladder diary before and after 4 weeks' duloxetine versus imipramine treatment.

Official Title
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Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy in Women With Stress Urinary Incontinence: a Randomized Controlled Study.

Conditions
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Women With Stress Urinary Incontinence

Intervention / Treatment
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* Drug: duloxetine
* Drug: Imipramine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients over 25 years old with stress urinary incontinence. Patients who are currently not considered for surgical treatment. Patients who have undergone regular Kegel exercises but have poor results. Exclusion Criteria: The result of urodynamic examination, if the main cause of urinary incontinence is detrusor overactivity. Those who are taking or plan to take monoamine oxidase inhibitor (MAOI) inhibitors. Patients with acute myocardial infarction. Those who are allergic to duloxetine, imipramine and dibenzazepine tricyclic antidepressants. Patients with uncontrolled narrow-angle glaucoma. Pregnant women. Those who are contraindicated to duloxetine or imipramine. Patients with suicidal ideation and behavior.

Ages Eligible for Study
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Minimum Age: 25 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br> | Drug: duloxetine<br>* Duloxetine 30 mg per day<br>|
| Active Comparator: Imipramine<br> | Drug: Imipramine<br>* Imipramine 25 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of stress urinary incontinence | Urinary Incontinence Questionnaire (by ICIQ-UI short form) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of urgency symptoms | Urgency severity scale | 4 weeks | 
| Improvement of overactive bladder symptoms | Overactive bladder symptom score | 4 weeks |