Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder (NemoPGAD)

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 Overview

• Status: Completed
• Conditions: Arousal Disorders, Sexual
• Intervention / Treatment: Device: Neuromodulation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboud Unversity Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women with PGAD

Exclusion Criteria:

• Women < 18 years
• Women not able to handle the neuromodulator
• Women in whom the anatomy of the genitals precludes proper electrode placement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromodulation; Neuromodulation every day, for 3 weeks	Device: Neuromodulation; Neuromodulation by UCon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom severity	Symptom severity on a 5-point Likert scale, filled in daily. 1 indicates no symptoms at all, 5 indicates very severe symptoms.	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.	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.	At the end of the treatment, at week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	During follow-up (after week 8)

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): April 22, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Neuromodulation; Neurostimulation; Persistent Genital Arousal Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: 2023-16221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No