drugset / Trial / NCT03102645

Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?

NCT03102645

Phase 1 Completed 16 enrolled Jonatan Kornholt
RandomizedCrossoverTriple-blindBasic science

Summary

A double-blinded, randomized, crossover study in healthy females with placebo and single dose imipramine 50 mg. Primary objective: Does imipramine increase the tone of the external urethral sphincter? Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). UOP increases correlate with effect in treating stress urinary incontinence. Can imipramine treat stress urinary incontinence? Secondary objective: Does imipramine increase the tone of the anal sphincter? The opening pressure is measured with Anal Acoustic Reflectometry (AAR). The investigators also wish to establish the within-subject standard deviation for AAR to enable power calculations in future studies.

Timeline

Start
2017-05-16
Primary completion
2017-06-16
Completion
2017-06-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Imipramine Small molecule 50 mg