The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
NCT ID: NCT05804552
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2023-03-28
2023-03-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Dorsal genital nerve stimulation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Signed an informed consent
Exclusion Criteria
* 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.
18 Years
55 Years
FEMALE
Yes
Sponsors
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InnoCon Medical
INDUSTRY
Thea Christoffersen
OTHER
Responsible Party
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Thea Christoffersen
Medical Doctor, Principal Investigator
Locations
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Zelo Phase 1 unit
Copenhagen, , Denmark
Countries
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Other Identifiers
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H-22063824
Identifier Type: -
Identifier Source: org_study_id