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Therapeutic Efficacy in Women With Stress Urinary Incontinence

Primary Purpose

Women With Stress Urinary Incontinence

Status
Recruiting
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 Women With Stress Urinary Incontinence

Eligibility Criteria

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

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.

Sites / Locations

  • Department of Obstetrics and Gynecology, Far Eastern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Duloxetine

Imipramine

Arm Description

Outcomes

Primary Outcome Measures

Improvement of stress urinary incontinence
Urinary Incontinence Questionnaire (by ICIQ-UI short form)

Secondary Outcome Measures

Improvement of urgency symptoms
Urgency severity scale
Improvement of overactive bladder symptoms
Overactive bladder symptom score

Full Information

First Posted
January 1, 2023
Last Updated
May 18, 2023
Sponsor
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05677295
Brief Title
Therapeutic Efficacy in Women With Stress Urinary Incontinence
Official Title
Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy in Women With Stress Urinary Incontinence: a Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women With 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
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm Title
Imipramine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
duloxetine
Intervention Description
Duloxetine 30 mg per day
Intervention Type
Drug
Intervention Name(s)
Imipramine
Intervention Description
Imipramine 25 mg per day
Primary Outcome Measure Information:
Title
Improvement of stress urinary incontinence
Description
Urinary Incontinence Questionnaire (by ICIQ-UI short form)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Improvement of urgency symptoms
Description
Urgency severity scale
Time Frame
4 weeks
Title
Improvement of overactive bladder symptoms
Description
Overactive bladder symptom score
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Mou Hsiao, MD
Phone
+886289667000
Ext
1818
Email
smhsiao2@gmail.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Mou Hsiao, M.D.
Phone
+886-2-89667000
Ext
1818
Email
smhsiao2@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapeutic Efficacy in Women With Stress Urinary Incontinence

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