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

Fecal Incontinence Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102645
• Other study ID #: TCA-UPR-0001
• Status: Completed
• Phase: Phase 1
• Start date: May 16, 2017
• Est. completion date: June 21, 2017

Study information

• Verified date: January 2021
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 21, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
Denmark	Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital	Copenhagen	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Jonatan Kornholt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urethral Opening Pressure (UOP)	Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).	Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
Secondary	Anal Opening Pressure (AOP)	Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR).	Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.