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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

Primary Purpose

Stress Urinary Incontinence

Status
Withdrawn
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Duloxetine
Imipramine
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Duloxetine

Imipramine

Arm Description

Receive Duloxetine 30 mg treatment per day

Receive Imipramine 25 mg treatment per day

Outcomes

Primary Outcome Measures

the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence
Between-group difference in the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence

Secondary Outcome Measures

the score of Urgency Severity Scale
Between-group difference in the score of Urgency Severity Scale

Full Information

First Posted
May 31, 2020
Last Updated
August 14, 2022
Sponsor
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04412876
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Failed to pass the Ministry of Science and Technology.
Study Start Date
May 31, 2020 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
June 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
Receive Duloxetine 30 mg treatment per day
Arm Title
Imipramine
Arm Type
Active Comparator
Arm Description
Receive Imipramine 25 mg treatment per day
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Duloxetine 30 mg qd
Intervention Type
Drug
Intervention Name(s)
Imipramine
Intervention Description
Imipramine 25mg qd
Primary Outcome Measure Information:
Title
the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence
Description
Between-group difference in the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
the score of Urgency Severity Scale
Description
Between-group difference in the score of Urgency Severity Scale
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
the score of Overactive Bladder Symptom Score
Description
Between-group difference in the score of Overactive Bladder Symptom Score
Time Frame
8 weeks
Title
the score of King's health questionnaires
Description
Between-group difference in the score of King's health questionnaires
Time Frame
8 weeks
Title
the score of Brief symptom rating scale
Description
Between-group difference in the score of Brief symptom rating scale
Time Frame
8 weeks
Title
the score of Female sexual function index
Description
Between-group difference in the score of Female sexual function index
Time Frame
8 weeks
Title
Blood flow index of the bladder
Description
Between-group difference in the changes of blood flow index of the bladder
Time Frame
8 weeks
Title
Bladder wall thickness
Description
Between-group difference in the changes of Bladder wall thickness
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Stress urinary incontinence Exclusion Criteria: 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
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
City
Banqiao
State/Province
New Taipei
ZIP/Postal Code
22050
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this 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

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