Study Stopped
Failed to pass the Ministry of Science and Technology.
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
1 other identifier
interventional
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2020
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2020
CompletedStudy Start
First participant enrolled
May 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2021
CompletedAugust 17, 2022
June 1, 2021
Same day
May 31, 2020
August 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
the score of Urgency Severity Scale
8 weeks
Other Outcomes (6)
the score of Overactive Bladder Symptom Score
8 weeks
the score of King's health questionnaires
8 weeks
the score of Brief symptom rating scale
8 weeks
- +3 more other outcomes
Study Arms (2)
Duloxetine
EXPERIMENTALReceive Duloxetine 30 mg treatment per day
Imipramine
ACTIVE COMPARATORReceive Imipramine 25 mg treatment per day
Interventions
Eligibility Criteria
You may qualify if:
- \- Stress urinary incontinence
You may not qualify if:
- Take monoamine oxidase
- Myocardial infarction critical,cardiovascular insufficiency (such as room blocking, arrhythmia, blood-soaked heart failure, myocardial infarction, stroke and excessive heartbeat).
- Allergy to duloxetine or imipramine
- Uncontrolled angular glaucoma patients
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Department of Obstetrics & Gynecology
Study Record Dates
First Submitted
May 31, 2020
First Posted
June 2, 2020
Study Start
May 31, 2020
Primary Completion
May 31, 2020
Study Completion
June 3, 2021
Last Updated
August 17, 2022
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share