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

Jonatan Kornholt

Status and phase

Completed

Phase 1

Conditions

Urinary Incontinence, Stress

Fecal Incontinence

Treatments

Drug: Placebo Oral Tablet

Drug: Imipramine Hydrochloride 25 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT03102645

TCA-UPR-0001

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.