The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Stress Urinary Incontinence Clinical Trial

Official title:

The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05804552
• Other study ID #: H-22063824
• Status: Completed
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2023
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
Denmark	Zelo Phase 1 unit	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Thea Christoffersen	InnoCon Medical

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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