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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.

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05677295
Enrollment
90
Registered
2023-01-10
Start date
2023-04-18
Completion date
2024-12-31
Last updated
2023-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women With Stress Urinary Incontinence

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.

Interventions

DRUGduloxetine

Duloxetine 30 mg per day

DRUGImipramine

Imipramine 25 mg per day

Sponsors

Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement of stress urinary incontinence4 weeksUrinary Incontinence Questionnaire (by ICIQ-UI short form)

Secondary

MeasureTime frameDescription
Improvement of urgency symptoms4 weeksUrgency severity scale
Improvement of overactive bladder symptoms4 weeksOveractive bladder symptom score

Countries

Taiwan

Contacts

Primary ContactSheng-Mou Hsiao, MD
smhsiao2@gmail.com+886289667000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026