The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 28, 2023

Primary Completion Date

March 30, 2023

Study Completion Date

March 30, 2023

Conditions
Stress Urinary Incontinence
Interventions
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.

Trial Locations (1)

2400

Zelo Phase 1 unit, Copenhagen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

InnoCon Medical

INDUSTRY

lead

Thea Christoffersen

OTHER