Therapeutic Efficacy in Women With Stress Urinary Incontinence

May 18, 2023 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy in Women With Stress Urinary Incontinence: a Randomized Controlled Study.

We will get the impact of duloxetine versus imipramine on therapeutic efficacy in women with SUI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background/Purpose: Pharmacologic treatments for female stress urinary incontinence (SUI) include duloxetine and imipramine. Duloxetine and Imipramine has been reported to have clinical significant therapeutic efficacy on female SUI and overactive bladder syndrome. However, there was no randomized controlled study to compare duloxetine and imipramine for the treatment of female SUI.

Patients and Methods: We will perform a prospective randomized controlled study to recruit 90 female SUI patients at the Obstetrics & Gynecology outpatient clinic of Far Eastern Memorial Hospital. All SUI female patients will be asked to complete ICIQ-UI, USS, OABSS, and bladder diary before and after 4 weeks' duloxetine versus imipramine treatment.

Study Type

Interventional

Enrollment (Anticipated)

90

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 Contact

Study Locations

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

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

Description

Inclusion Criteria:

  • Female patients over 25 years old with stress urinary incontinence.
  • Patients who are currently not considered for surgical treatment.
  • Patients who have undergone regular Kegel exercises but have poor results.

Exclusion Criteria:

  • The result of urodynamic examination, if the main cause of urinary incontinence is detrusor overactivity.
  • Those who are taking or plan to take monoamine oxidase inhibitor (MAOI) inhibitors.
  • Patients with acute myocardial infarction.
  • Those who are allergic to duloxetine, imipramine and dibenzazepine tricyclic antidepressants.
  • Patients with uncontrolled narrow-angle glaucoma.
  • Pregnant women.
  • Those who are contraindicated to duloxetine or imipramine.
  • Patients with suicidal ideation and behavior.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duloxetine
Drug: duloxetine
Duloxetine 30 mg per day
Active Comparator: Imipramine
Drug: Imipramine
Imipramine 25 mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of stress urinary incontinence
Time Frame: 4 weeks
Urinary Incontinence Questionnaire (by ICIQ-UI short form)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of urgency symptoms
Time Frame: 4 weeks
Urgency severity scale
4 weeks
Improvement of overactive bladder symptoms
Time Frame: 4 weeks
Overactive bladder symptom score
4 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)

April 18, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 1, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111220-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.

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