The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Study Overview
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Brief Summary
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This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.

Official Title
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The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Dorsal genital nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2) Signed an informed consent Exclusion Criteria: Any history of clinically significant diseases, unless regarded irrelevant and/or stable by the investigator Any history or evidence of clinically significant urinary incontinence, urinary retention, overactive bladder, or other voiding dysfunction Known or suspected nerve injuries or paraesthesia in the pelvic area Pregnancy within six months before enrolment Breastfeeding within three months before enrolment Smoking or other regular use of any form of nicotine product during the study period and the previous 3 months Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator) Any systemic drug use within 2 weeks before the first study day (prescription drugs, over-the-counter drugs, herbal drugs, and/or illicit drugs), except for occasional use of paracetamol (up to 4 g/day), ibuprofen, or antihistamine, hormonal contraceptives and hormone replacement therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dorsal genital nerve stimulation<br> | Device: Dorsal genital nerve stimulation<br>* Two types of stimulation electrodes will be used: UCon Patch Electrodes (InnoCon Medical ApS, Denmark) and ValuTrodes/EconoStim Electrodes (5x5 cm, Axelgaard Manufacturing Co. Ltd., United States). The UCon Patch Electrode acts as a cathode and will be placed on the clitoris. The ValuTrode/EconoStim acts as an anode and will be placed on the lower abdomen. The continuous stimulation consists of a train of single pulses provided continuously with a frequency of 20 Hz and a pulse duration of 200 μs. The burst stimulus pattern consists of a train of bursts. The length of the train is 10 s and will consist of 20-30 bursts/s. One burst consists of 5 identical square pulses (monophasic). The inter-pulse interval is 4 ms (time between the onset of 2 consecutive pulses) while a pulse duration of 200 μs will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of burst dorsal genital nerve stimulation compared to baseline | The difference in mean opening urethral pressure (in cmH20) measured with urethral pressure reflectometry during electrical burst stimulation of dorsal genital nerve (reflex-induced pelvic floor contraction) compared to mean baseline opening urethral pressure during squeezing condition | Baseline and during dorsal genital nerve stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline | The difference in mean opening urethral pressure (in cmH20) measured with urethral pressure reflectometry during maximal tolerated continuous dorsal genital nerve stimulation compared to mean baseline OUP (resting condition). | Baseline and during dorsal genital nerve stimulation | 
| Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline | The difference in mean opening urethral pressure (in cmH20) measured with urethral pressure reflectometry during maximal tolerated continuous dorsal genital nerve stimulation compared to mean baseline opening urethral pressure (squeezing condition). | Baseline and during dorsal genital nerve stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Stimulation, Urethral pressure, Neuromodulation