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Completed

NCT Number: NCT03102645

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

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.

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Key information

Conditions

Urinary Incontinence, Stress Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo oral tablet

Drug

Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc

Imipramine Hydrochloride 25 MG

Drug

Two Imipramin DAK film coated tablets 25 mg each, single dose

Other names: Imipramin DAK

Primary outcomes

  1. Urethral Opening Pressure (UOP)

    Time frame: 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 outcomes

  1. Anal Opening Pressure (AOP)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Jonatan Kornholt

Other

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2017
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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