Therapeutic Efficacy in Women With Stress Urinary Incontinence

Phase 3

Recruiting

• Conditions: Women With Stress Urinary Incontinence
• Interventions: Drug: Imipramine; Drug: duloxetine

• Registration Number: NCT05677295
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Status Verified: 2023-04
• Study Start: 2023-04-18
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-19
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imipramine	Imipramine	-
Duloxetine	duloxetine	-

Primary Outcome Measures

Name	Time	Method
Improvement of stress urinary incontinence	4 weeks	Urinary Incontinence Questionnaire (by ICIQ-UI short form)

Secondary Outcome Measures

Name	Time	Method
Improvement of overactive bladder symptoms	4 weeks	Overactive bladder symptom score
Improvement of urgency symptoms	4 weeks	Urgency severity scale

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan