The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Thea Christoffersen

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Dorsal genital nerve stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05804552

H-22063824

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Dorsal genital nerve stimulation

Experimental group

Treatment:

Device: Dorsal genital nerve stimulation