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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
16
Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc
Two Imipramin DAK film coated tablets 25 mg each, single dose
Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark
Urethral Opening Pressure (UOP)
Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).
Time frame: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
Anal Opening Pressure (AOP)
Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR).
Time frame: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
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