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
Organization
Far Eastern Memorial HospitalDrug
duloxetineIndication
Stress Urinary IncontinenceProduct
Imipramine