MedTrace Logo

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

NCT03102645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-02-12

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • Jonatan Kornholt

    lead OTHER

Principal Investigators

  • Jonatan Kornholt, MD · Klinisk farmakologisk afdeling, Bispebjerg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102645 on ClinicalTrials.gov