Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study

NCT ID: NCT04412876

Last Updated: 2022-08-17

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

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-31

Study Completion Date

2021-06-03

Brief Summary

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To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Detailed Description

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To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Conditions

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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

Receive Duloxetine 30 mg treatment per day

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

Duloxetine 30 mg qd

Imipramine

Receive Imipramine 25 mg treatment per day

Group Type ACTIVE_COMPARATOR

Imipramine

Intervention Type DRUG

Imipramine 25mg qd

Interventions

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Duloxetine

Duloxetine 30 mg qd

Intervention Type DRUG

Imipramine

Imipramine 25mg qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Stress urinary incontinence

Exclusion Criteria

1. Take monoamine oxidase
2. Myocardial infarction critical,cardiovascular insufficiency (such as room blocking, arrhythmia, blood-soaked heart failure, myocardial infarction, stroke and excessive heartbeat).
3. Allergy to duloxetine or imipramine
4. Uncontrolled angular glaucoma patients
5. Pregnant women
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 of Department of Obstetrics & 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

Countries

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Taiwan

Other Identifiers

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109017-F

Identifier Type: -

Identifier Source: org_study_id

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