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Therapeutic Efficacy in Women With Stress Urinary Incontinence

F

Far Eastern Memorial Hospital

Status and phase

Enrolling
Phase 3

Conditions

Women With Stress Urinary Incontinence

Treatments

Drug: duloxetine
Drug: Imipramine

Study type

Interventional

Funder types

Other

Identifiers

NCT05677295
111220-F

Details and patient eligibility

About

We will get the impact of duloxetine versus imipramine on therapeutic efficacy in women with SUI.

Full 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.

Enrollment

90 estimated patients

Sex

Female

Ages

25+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Duloxetine
Experimental group
Treatment:
Drug: duloxetine
Imipramine
Active Comparator group
Treatment:
Drug: Imipramine

Trial contacts and locations

1

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Central trial contact

Sheng-Mou Hsiao, MD

Data sourced from clinicaltrials.gov

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