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The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Sponsor
Thea Christoffersen (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05804552
Collaborator
InnoCon Medical (Industry)
10
Enrollment
1
Location
1
Arm
8.1
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Dorsal genital nerve stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
Actual Study Start Date :
Mar 28, 2023
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

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.

Outcome Measures

Primary Outcome Measures

  1. Effect of burst dorsal genital nerve stimulation compared with baseline [Baseline and during dgn stimulation]

    The difference in mean OUP during electrical burst stimulation of DGN (reflex-induced pelvic floor contraction) compared to mean baseline OUP during squeezing condition

Secondary Outcome Measures

  1. Effect of continous dorsal genital nerve stimultaion on resting pressure compared with baseline [Baseline and during dgn stimulation]

    The difference in mean OUP during maximal tolerated continuous DGN stimulation compared to mean baseline OUP (resting condition).

  2. Effect of continous dorsal genital nerve stimultaion on squeezing pressure compared with baseline [Baseline and during dgn stimulation]

    The difference in mean OUP during maximal tolerated continuous DGN stimulation compared to mean baseline OUP (squeezing condition).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zelo Phase 1 unit Copenhagen Denmark 2400

Sponsors and Collaborators

  • Thea Christoffersen
  • InnoCon Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thea Christoffersen, Medical Doctor, Principal Investigator, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier:
NCT05804552
Other Study ID Numbers:
  • H-22063824
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thea Christoffersen, Medical Doctor, Principal Investigator, University Hospital Bispebjerg and Frederiksberg
Nervestimulation
Urethral pressure
Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress

Study Results

No Results Posted as of Apr 7, 2023