Stress Urinary IncontinenceNCT05804552
The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
A study testing Dorsal genital nerve stimulation in people with Stress Urinary Incontinence, run by Thea Christoffersen at 1 site in Denmark.
Trial summary
This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Dorsal genital nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Mar 2023to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
- Signed an informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Dorsal genital nerve stimulation
- Keywords
- Electrical Stimulation, Urethral pressure, Neuromodulation
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal genital nerve stimulation | Experimental | Not described Receives: Device: Dorsal genital nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and during dorsal genital nerve stimulation
Secondary outcomes (2)
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).
Measured: Baseline and during dorsal genital nerve stimulation
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).
Measured: Baseline and during dorsal genital nerve stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start28 Mar 2023
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thea Christoffersen
- Sponsor type
- University, hospital or other
- Collaborators
- InnoCon Medical
- Responsible party
- Sponsor-investigator, Thea Christoffersen, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804552
- Sponsor's protocol ID
- H-22063824
- Status last verified
- Nov 2023
- First submitted
- 27 Mar 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dorsal Genital Nerve Stimulation on Opening Urethral Pressure
- ClinicalTrials.gov ID
- NCT05804552
- Acronym / sponsor ID
- H-22063824
- Conditions
- Stress Urinary Incontinence
- Keywords
- Electrical Stimulation, Urethral pressure, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Thea ChristoffersenUniversity, hospital or other
- Collaborators
- InnoCon Medical
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of electrical stimulation of the dorsal genital nerve on the urethral pressure in healthy women.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dorsal genital nerve stimulation | Experimental | Device: Dorsal genital nerve stimulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal weight (Body weight 50 kg or more, Body Mass Index 18-5-30 kg/m2)
- Signed an informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsal genital nerve stimulationTwo 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. | Device | Dorsal genital nerve stimulation |
Primary outcome
Effect of burst dorsal genital nerve stimulation compared to baseline
Time frame: 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
2 secondary outcomes
Effect of continuous dorsal genital nerve stimulation on resting pressure compared to baseline
Time frame: Baseline and during dorsal genital nerve stimulation
Effect of continuous dorsal genital nerve stimulation on squeezing pressure compared to baseline
Time frame: Baseline and during dorsal genital nerve stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsal genital nerve stimulation in people with Stress Urinary Incontinence, run by Thea Christoffersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of burst dorsal genital nerve stimulation compared to baseline (time frame: Baseline and during dorsal genital nerve stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.