Clinical trial

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

Name
111220-F
Description
We will get the impact of duloxetine versus imipramine on therapeutic efficacy in women with SUI.
Trial arms
Trial start
2023-04-18
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
duloxetine
Duloxetine 30 mg per day
Arms:
Duloxetine
Imipramine
Imipramine 25 mg per day
Arms:
Imipramine
Size
90
Primary endpoint
Improvement of stress urinary incontinence
4 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-05-19

1 organization

1 product

1 drug

1 indication

Product
Imipramine