Skip to main content
OpenTrials
Completed

NCT Number: NCT05804552

The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zelo Phase 1 unit

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Dorsal genital nerve stimulation

Device

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.

Primary outcomes

  1. Effect of burst dorsal genital nerve stimulation compared to baseline

    Time frame: Baseline and during dorsal genital nerve stimulation

    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

Secondary outcomes

  1. Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline

    Time frame: Baseline and during dorsal genital nerve stimulation

    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).

  2. Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline

    Time frame: Baseline and during dorsal genital nerve stimulation

    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).

Sponsors and collaborators

Lead sponsor

Thea Christoffersen

Other

Collaborators

  • InnoCon Medical

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Nov 29, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.