Therapeutic Efficacy in Women With Stress Urinary Incontinence

Last updated: May 18, 2023
Sponsor: Far Eastern Memorial Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Enuresis

Urinary Incontinence

Treatment

Imipramine

duloxetine

Clinical Study ID

NCT05677295
111220-F
  • Ages > 25
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • The result of urodynamic examination, if the main cause of urinary incontinence isdetrusor 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 tricyclicantidepressants.
  • Patients with uncontrolled narrow-angle glaucoma.
  • Pregnant women.
  • Those who are contraindicated to duloxetine or imipramine.
  • Patients with suicidal ideation and behavior.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Imipramine
Phase: 3
Study Start date:
April 18, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

    Banqiao, New Taipei 22050
    Taiwan

    Active - Recruiting

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