Arousal Disorders, SexualNemoPGADNCT06790563
Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder
A study testing Neuromodulation in people with Arousal Disorders, Sexual, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to learn if neuromodulation of the dorsal genital nerve works to treat symptoms related to Persistent Genital Arousal Disorder in women. The main questions it aims to answer are: What is the effect of neuromodulation on PGAD symptoms in women? Participants will: Use a neurosimulator… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Arousal Disorders, Sexual
- What is being tested?
- Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Apr 2023to 22 Apr 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with PGAD
Who cannot join
- Women < 18 years
- Women not able to handle the neuromodulator
- Women in whom the anatomy of the genitals precludes proper electrode placement
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if neuromodulation of the dorsal genital nerve works to treat symptoms related to Persistent Genital Arousal Disorder in women. The main questions it aims to answer are:
What is the effect of neuromodulation on PGAD symptoms in women?
Participants will:
Use a neurosimulator every day for 3 weeks. Keep a diary of their symptoms and the number of times they used the neurostimulator Fill in questionaires
- Conditions
- Arousal Disorders, Sexual
- Being tested
- Neuromodulation
- Keywords
- Neuromodulation, Neurostimulation, Persistent Genital Arousal Disorder
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromodulationDevice
Neuromodulation by UCon
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation | Experimental | Neuromodulation every day, for 3 weeks Receives: Device: Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity
Symptom severity on a 5-point Likert scale, filled in daily. 1 indicates no symptoms at all, 5 indicates very severe symptoms.
Measured: 8 weeks
Neuromodulation effect
The neuromodulation effect will be assessed using a self-reported diary, where participants are prompted daily to rate their experience of symptoms in response to the question: "How do you experience your symptoms today?" Responses are recorded on a 5-point Likert scale with the following options: "No problem," "Mild," "Moderate," "Severe," or "Very severe." This dairy is quaried during the three weeks intervention period, in which the participants use the neuromodulator device daily.
Measured: 3 weeks
Satisfaction device
The consideration of using the neuromodulator device as part of their treatment, which was asked at the end of the treatment with the question "Would you like to continue using the device as part of your treatment". Following with a 'Yes' or 'No' answer.
Measured: At the end of the treatment, at week 8
Secondary outcomes (4)
HADS
Hospital Anxiety and Depression Scale, measuring the level of anxiety and depression, both scores ranging from 0 to 21:
0-7 : no anxiety disorder or depression 8-10 : possible anxiety disorder or depression 11-21: suspected anxiety disorder or depression
Measured: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)
PCS
Pain Catestrophizing Scale. Score ranging from 0 to 52, in which a higher score indicates a higher level of pain catestrophizing.
Measured: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)
QoL
Quality of Life measured with the EQ-5D-3L (EuroQol-5 Dimensions-3 Levels). The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. Higher EQ VAS score indicated higher self-related health.
Measured: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)
Patient Global Impression of Improvement
Patient Global Impression of Improvement (PGI-I) is a scale to rate the patients condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.
Measured: During follow-up (after week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start26 Apr 2023
- Primary completion20 Feb 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arousal Disorders, SexualStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790563
- Sponsor's protocol ID
- 2023-16221
- Other IDs
- 2023
- Acronym
- NemoPGAD
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 23 Apr 2025
- 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 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder
- ClinicalTrials.gov ID
- NCT06790563
- Acronym / sponsor ID
- NemoPGAD / 2023-16221
- Conditions
- Arousal Disorders, Sexual
- Keywords
- Neuromodulation, Neurostimulation, Persistent Genital Arousal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 24 Jan 2025 (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.
The goal of this clinical trial is to learn if neuromodulation of the dorsal genital nerve works to treat symptoms related to Persistent Genital Arousal Disorder in women. The main questions it aims to answer are:
What is the effect of neuromodulation on PGAD symptoms in women?
Participants will:
Use a neurosimulator every day for 3 weeks. Keep a diary of their symptoms and the number of times they used the neurostimulator Fill in questionaires
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation | Experimental | Device: NeuromodulationNeuromodulation every day, for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with PGAD
Key exclusion criteria (3 listed)
- Women < 18 years
- Women not able to handle the neuromodulator
- Women in whom the anatomy of the genitals precludes proper electrode placement
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 |
|---|---|---|
| NeuromodulationNeuromodulation by UCon | Device | Neuromodulation |
Primary outcome
Symptom severity
Time frame: 8 weeks
Symptom severity on a 5-point Likert scale, filled in daily. 1 indicates no symptoms at all, 5 indicates very severe symptoms.
Neuromodulation effect
Time frame: 3 weeks
The neuromodulation effect will be assessed using a self-reported diary, where participants are prompted daily to rate their experience of symptoms in response to the question: "How do you experience your symptoms today?" Responses are recorded on a 5-point Likert scale with the following options: "No problem," "Mild," "Moderate," "Severe," or "Very severe." This dairy is quaried during the three weeks intervention period, in which the participants use the neuromodulator device daily.
Satisfaction device
Time frame: At the end of the treatment, at week 8
The consideration of using the neuromodulator device as part of their treatment, which was asked at the end of the treatment with the question "Would you like to continue using the device as part of your treatment". Following with a 'Yes' or 'No' answer.
4 secondary outcomes
HADS
Time frame: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)
PCS
Time frame: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)
QoL
Time frame: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)
Patient Global Impression of Improvement
Time frame: During follow-up (after week 8)
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 23 Apr 2025.
- 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 Neuromodulation in people with Arousal Disorders, Sexual, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 inclusion and 3 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 23 Apr 2025. 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 Netherlands. 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?
Symptom severity (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 23 Apr 2025.