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Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study

NCT04412876 — Phase 3, Withdrawn, Far Eastern Memorial Hospital
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RegistryNCT04412876
StatusWithdrawn - Failed to pass the Ministry of Science and Technology.
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
SponsorFar Eastern Memorial Hospital (Other)
ConditionsStress Urinary Incontinence
InterventionsDuloxetine, Imipramine (Drug)
Datesstart 2020-05-31, primary completion 2020-05-31, completion 2021-06-03, first posted 2020-06-02, last updated 2022-08-17
Locations1 site in Taiwan

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-Summary

To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

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+Detailed description

To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

+Arms and interventions

ArmTypeInterventionsDescription
DuloxetineExperimentalDrug: DuloxetineReceive Duloxetine 30 mg treatment per day
ImipramineActive comparatorDrug: ImipramineReceive Imipramine 25 mg treatment per day
  • Duloxetine (Drug): Duloxetine 30 mg qd
  • Imipramine (Drug): Imipramine 25mg qd

+Outcome measures

Primary outcomes

  • the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence [8 weeks]: Between-group difference in the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence

Secondary outcomes

  • the score of Urgency Severity Scale [8 weeks]: Between-group difference in the score of Urgency Severity Scale

Other outcomes

  • the score of Overactive Bladder Symptom Score [8 weeks]: Between-group difference in the score of Overactive Bladder Symptom Score
  • the score of King's health questionnaires [8 weeks]: Between-group difference in the score of King's health questionnaires
  • the score of Brief symptom rating scale [8 weeks]: Between-group difference in the score of Brief symptom rating scale
  • the score of Female sexual function index [8 weeks]: Between-group difference in the score of Female sexual function index
  • Blood flow index of the bladder [8 weeks]: Between-group difference in the changes of blood flow index of the bladder
  • Bladder wall thickness [8 weeks]: Between-group difference in the changes of Bladder wall thickness

+Eligibility

Sex: Female, ages: 25 Years to any

Inclusion Criteria:

\- Stress urinary incontinence

Exclusion Criteria:

1. Take monoamine oxidase
2. Myocardial infarction critical,cardiovascular insufficiency (such as room blocking, arrhythmia, blood-soaked heart failure, myocardial infarction, stroke and excessive heartbeat).
3. Allergy to duloxetine or imipramine
4. Uncontrolled angular glaucoma patients
5. Pregnant women

+Locations (1)

FacilityCityCountryStatus
Department of Obstetrics and Gynecology, Far-Eastern Memorial HospitalBanqiao District, New TaipeiTaiwan

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