Therapeutic Efficacy in Women With Stress Urinary Incontinence

Sponsor

Far Eastern Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05677295

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Women With Stress Urinary Incontinence	Drug: duloxetine Drug: Imipramine	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Duloxetine

Drug: duloxetine

Duloxetine 30 mg per day

Active Comparator: Imipramine

Drug: Imipramine

Imipramine 25 mg per day

Outcome Measures

Primary Outcome Measures

Improvement of stress urinary incontinence [4 weeks]
Urinary Incontinence Questionnaire (by ICIQ-UI short form)

Secondary Outcome Measures

Improvement of urgency symptoms [4 weeks]
Urgency severity scale
Improvement of overactive bladder symptoms [4 weeks]
Overactive bladder symptom score

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital	Banqiao	New Taipei	Taiwan	22050

Sponsors and Collaborators

Far Eastern Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheng-Mou Hsiao, Chief and Associate Professor, Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

ClinicalTrials.gov Identifier:

NCT05677295

Other Study ID Numbers:

111220-F

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Duloxetine Hydrochloride

Imipramine

Study Results

No Results Posted as of Jan 19, 2023