- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05677295
Therapeutic Efficacy in Women With Stress Urinary Incontinence
Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy in Women With Stress Urinary Incontinence: a Randomized Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Sheng-Mou Hsiao, MD
- Phone Number: 1818 +886289667000
- Email: smhsiao2@gmail.com
Study Locations
-
-
New Taipei
-
Banqiao, New Taipei, Taiwan, 22050
- Recruiting
- Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
-
Contact:
- Sheng-Mou Hsiao, M.D.
- Phone Number: 1818 +886-2-89667000
- Email: smhsiao2@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Duloxetine
|
Duloxetine 30 mg per day
|
Active Comparator: Imipramine
|
Imipramine 25 mg per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of stress urinary incontinence
Time Frame: 4 weeks
|
Urinary Incontinence Questionnaire (by ICIQ-UI short form)
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of urgency symptoms
Time Frame: 4 weeks
|
Urgency severity scale
|
4 weeks
|
Improvement of overactive bladder symptoms
Time Frame: 4 weeks
|
Overactive bladder symptom score
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Elimination Disorders
- Urinary Incontinence
- Enuresis
- Urinary Incontinence, Stress
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Duloxetine Hydrochloride
- Imipramine
Other Study ID Numbers
- 111220-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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