NCT03102645

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Jonatan Kornholt · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Incontinence, Stress
• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	Placebo Oral Tablet	Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc
DRUG	Imipramine Hydrochloride 25 MG	Two Imipramin DAK film coated tablets 25 mg each, single dose

Timeline

• Start date: 2017-05-16
• Primary completion: 2017-06-16
• Completion: 2017-06-21
• First posted: 2017-04-06
• Last updated: 2021-02-12
• Results posted: 2021-02-12

Locations

1 site across 1 country: Denmark