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

August 14, 2022 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital
To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 22050
        • Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Duloxetine
Receive Duloxetine 30 mg treatment per day
Drug: Duloxetine
Duloxetine 30 mg qd
ACTIVE_COMPARATOR: Imipramine
Receive Imipramine 25 mg treatment per day
Drug: Imipramine
Imipramine 25mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence
Time Frame: 8 weeks
Between-group difference in the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the score of Urgency Severity Scale
Time Frame: 8 weeks
Between-group difference in the score of Urgency Severity Scale
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the score of Overactive Bladder Symptom Score
Time Frame: 8 weeks
Between-group difference in the score of Overactive Bladder Symptom Score
8 weeks
the score of King's health questionnaires
Time Frame: 8 weeks
Between-group difference in the score of King's health questionnaires
8 weeks
the score of Brief symptom rating scale
Time Frame: 8 weeks
Between-group difference in the score of Brief symptom rating scale
8 weeks
the score of Female sexual function index
Time Frame: 8 weeks
Between-group difference in the score of Female sexual function index
8 weeks
Blood flow index of the bladder
Time Frame: 8 weeks
Between-group difference in the changes of blood flow index of the bladder
8 weeks
Bladder wall thickness
Time Frame: 8 weeks
Between-group difference in the changes of Bladder wall thickness
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 31, 2020

Primary Completion (ACTUAL)

May 31, 2020

Study Completion (ACTUAL)

June 3, 2021

Study Registration Dates

First Submitted

May 31, 2020

First Submitted That Met QC Criteria

May 31, 2020

First Posted (ACTUAL)

June 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 14, 2022

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109017-F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Urinary Incontinence

Clinical Trials on Duloxetine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe