Therapeutic Efficacy in Women With Stress Urinary Incontinence

NCT ID: NCT05677295

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-18

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Women With Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Duloxetine

Group Type EXPERIMENTAL

duloxetine

Intervention Type DRUG

Duloxetine 30 mg per day

Imipramine

Group Type ACTIVE_COMPARATOR

Imipramine

Intervention Type DRUG

Imipramine 25 mg per day

Interventions

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duloxetine

Duloxetine 30 mg per day

Intervention Type DRUG

Imipramine

Imipramine 25 mg per day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Mou Hsiao

Chief and Professor, Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Mou Hsiao, MD

Role: CONTACT

+886289667000 ext. 1818

Facility Contacts

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Sheng-Mou Hsiao, M.D.

Role: primary

+886-2-89667000 ext. 1818

Other Identifiers

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111220-F

Identifier Type: -

Identifier Source: org_study_id

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