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NCT04412876 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04412876
Other study ID # 109017-F
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date May 31, 2020
Est. completion date June 3, 2021

Study information
Verified date June 2021
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 3, 2021
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 25 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Duloxetine
Duloxetine 30 mg qd
• Imipramine
Imipramine 25mg qd

Locations
Country Name City State
Taiwan Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital Banqiao New Taipei

Sponsors (1)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Other the score of Overactive Bladder Symptom Score Between-group difference in the score of Overactive Bladder Symptom Score 8 weeks
Other the score of King's health questionnaires Between-group difference in the score of King's health questionnaires 8 weeks
Other the score of Brief symptom rating scale Between-group difference in the score of Brief symptom rating scale 8 weeks
Other the score of Female sexual function index Between-group difference in the score of Female sexual function index 8 weeks
Other Blood flow index of the bladder Between-group difference in the changes of blood flow index of the bladder 8 weeks
Other Bladder wall thickness Between-group difference in the changes of Bladder wall thickness 8 weeks
Primary the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence Between-group difference in the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence 8 weeks
Secondary the score of Urgency Severity Scale Between-group difference in the score of Urgency Severity Scale 8 weeks
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