The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Dorsal genital nerve stimulation

• Registration Number: NCT05804552
• Lead Sponsor: Thea Christoffersen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Study Start: 2023-03-28
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Study First Posted: 2023-04-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dorsal genital nerve stimulation	Dorsal genital nerve stimulation	-

Primary Outcome Measures

Name	Time	Method
Effect of burst dorsal genital nerve stimulation compared to baseline	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 Outcome Measures

Name	Time	Method
Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline	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).
Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline	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).

Trial Locations

Locations (1)

Zelo Phase 1 unit; 🇩🇰 Copenhagen, Denmark