NCT05804552

The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Thea Christoffersen · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Dorsal genital nerve stimulation	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.

Timeline

• Start date: 2023-03-28
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2023-04-07
• Last updated: 2023-11-29

Locations

1 site across 1 country: Denmark