NCT05677295

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 18, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 19, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

January 1, 2023

Last Update Submit

May 18, 2023

Conditions

Women With Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Improvement of stress urinary incontinence

    Urinary Incontinence Questionnaire (by ICIQ-UI short form)

    4 weeks

Secondary Outcomes (2)

  • Improvement of urgency symptoms

    4 weeks

  • Improvement of overactive bladder symptoms

    4 weeks

Study Arms (2)

Duloxetine

EXPERIMENTAL
Drug: duloxetine

Imipramine

ACTIVE COMPARATOR
Drug: Imipramine

Interventions

duloxetineDRUG

Duloxetine 30 mg per day

Duloxetine
ImipramineDRUG

Imipramine 25 mg per day

Imipramine

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Interventions

Duloxetine HydrochlorideImipramine

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+886289667000smhsiao2@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief and Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 10, 2023

Study Start

April 18, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)