Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Symptom severity
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Neuromodulation
Neuromodulation every day, for 3 weeks
Intervention: Neuromodulation (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- HADS(At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8))
- PCS(At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8))
- QoL(At baseline, at the end of the intervention (week 3) and at the end of post-intervention (week 8))
- Patient Global Impression of Improvement(During follow-up (after week 8))