NCT05804552

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2 days

First QC Date

March 27, 2023

Last Update Submit

November 28, 2023

Conditions

Stress Urinary Incontinence

Keywords

Electrical StimulationUrethral pressureNeuromodulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline

    Baseline and during dorsal genital nerve stimulation

  • Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline

    Baseline and during dorsal genital nerve stimulation

Study Arms (1)

Dorsal genital nerve stimulation

EXPERIMENTAL
Device: Dorsal genital nerve stimulation

Interventions

Dorsal genital nerve stimulationDEVICE

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.

Dorsal genital nerve stimulation

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGender identidy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
  • Signed an informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zelo Phase 1 unit

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor, Principal Investigator

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 7, 2023

Study Start

March 28, 2023

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)