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

Phase 1

Completed

• Conditions: Urinary Incontinence, Stress; Fecal Incontinence
• Interventions: Drug: Placebo Oral Tablet; Drug: Imipramine Hydrochloride 25 MG

• Registration Number: NCT03102645
• Lead Sponsor: Jonatan Kornholt

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-06
• Study Start: 2017-05-16
• Primary Completion: 2017-06-16
• Study Completion: 2017-06-21
• Results First Submitted: 2019-04-09
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-25
• Last Update Submitted: 2021-01-25
• Results First Posted: 2021-02-12
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• Signed consent form.
• Healthy.
• Female.
• Non-smoker.
• Age 18 to 55, both inclusive.
• Normal weight: BMI 19.5 to 30.0 kg/m2. Weight minimum 50 kg.
• No breastfeeding.
• No pregnancy during the study.
• No other clinical trials during the study.

Exclusion Criteria

• Known allergy to imipramine or any of the other known constituents.
• Medical history with significant cardiovascular, gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, genitourologic, dermatologic, psychiatric, neurologic or dermatologic disease, lung disease, kidney disease, malignant disease or other significant diseases as assessed by the investigator.
• Medical history of urinary incontinence.
• Infectious disease 1 week prior to study day 1 or study day 2.
• Clinically significant findings during the physical examination.
• Pregnancy.
• Heart rate < 40 or > 100 beats per minute. Mean systolic blood pressure > 140 mmHg or mean diastolic blood pressure > 90 mmHg (mean of the measures on the screening day).
• Prescription, over the counter or herbal medication two weeks prior to study day 1 or study day 2. Excluding paracetamol and excluding oral contraceptives.
• Smoking 3 months prior to study day 1 or study day 2.
• Alcohol abuse, meaning > 14 units (12 g alcohol) per week within three weeks prior to study day 1 or study day 2.
• Drug abuse 3 months prior to study day 1 or study day 2.
• Any condition as assessed by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo first	Imipramine Hydrochloride 25 MG	A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2
Imipramine first	Placebo Oral Tablet	A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2
Placebo first	Placebo Oral Tablet	A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2
Imipramine first	Imipramine Hydrochloride 25 MG	A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2

Primary Outcome Measures

Name	Time	Method
Urethral Opening Pressure (UOP)	Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.	Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).

Secondary Outcome Measures

Name	Time	Method
Anal Opening Pressure (AOP)	Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.	Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR).

Trial Locations

Locations (1)

Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital; 🇩🇰 Copenhagen, Copenhagen NV, Denmark