Skip to main content
OpenTrials
Completed

NCT Number: NCT06790563

Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Radboud Unversity Medical Center

Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromodulation

Device

Neuromodulation by UCon

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. HADS

    Time frame: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)

    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

  2. PCS

    Time frame: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)

    Pain Catestrophizing Scale. Score ranging from 0 to 52, in which a higher score indicates a higher level of pain catestrophizing.

  3. QoL

    Time frame: At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8)

    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.

  4. Patient Global Impression of Improvement

    Time frame: During follow-up (after week 8)

    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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: NemoPGAD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.