At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Single Dose Imipramine on the Urethral and Anal Sphincter in Healthy Women Measured With Urethral Pressure Reflectometry (UPR) and Anal Acoustic Reflectometry (AAR)
In Brief
A Phase 1 clinical trial evaluating Placebo Oral Tablet and Imipramine Hydrochloride 25 MG for Urinary Incontinence, Stress and Fecal Incontinence. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc
Two Imipramin DAK film coated tablets 25 mg each, single dose