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The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

Primary Purpose

Stress Urinary Incontinence

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dorsal genital nerve stimulation
Sponsored by
Thea Christoffersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress Urinary Incontinence focused on measuring Electrical Stimulation, Urethral pressure, Neuromodulation

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Zelo Phase 1 unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dorsal genital nerve stimulation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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).

Full Information

First Posted
March 27, 2023
Last Updated
April 17, 2023
Sponsor
Thea Christoffersen
Collaborators
InnoCon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05804552
Brief Title
The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
Official Title
The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thea Christoffersen
Collaborators
InnoCon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Electrical Stimulation, Urethral pressure, Neuromodulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dorsal genital nerve stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Dorsal genital nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of burst dorsal genital nerve stimulation compared to baseline
Description
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
Time Frame
Baseline and during dorsal genital nerve stimulation
Secondary Outcome Measure Information:
Title
Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline
Description
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).
Time Frame
Baseline and during dorsal genital nerve stimulation
Title
Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline
Description
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).
Time Frame
Baseline and during dorsal genital nerve stimulation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender identidy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Zelo Phase 1 unit
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure

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