Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study

Phase 3

Withdrawn

• Conditions: Stress Urinary Incontinence
• Interventions: Drug: Duloxetine; Drug: Imipramine

• Registration Number: NCT04412876
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Detailed Description

To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Study Timeline

• Study Start: 2020-05-31
• Primary Completion: 2020-05-31
• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-05-31
• Study First Posted: 2020-06-02
• Status Verified: 2021-06
• Study Completion: 2021-06-03
• Last Update Submitted: 2022-08-14
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Stress urinary incontinence

Exclusion Criteria

1. Take monoamine oxidase
2. Myocardial infarction critical,cardiovascular insufficiency (such as room blocking, arrhythmia, blood-soaked heart failure, myocardial infarction, stroke and excessive heartbeat).
3. Allergy to duloxetine or imipramine
4. Uncontrolled angular glaucoma patients
5. Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duloxetine	Duloxetine	Receive Duloxetine 30 mg treatment per day
Imipramine	Imipramine	Receive Imipramine 25 mg treatment per day

Primary Outcome Measures

Name	Time	Method
the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence	8 weeks	Between-group difference in the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence

Secondary Outcome Measures

Name	Time	Method
the score of Urgency Severity Scale	8 weeks	Between-group difference in the score of Urgency Severity Scale

Trial Locations

Locations (1)

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