Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder

NCT06790563 | Completed

• 1 other identifier: 2023-16221
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Arousal Disorders, Sexual

Keywords

Neuromodulation; Neurostimulation; Persistent Genital Arousal Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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)

Study Arms (1)

Neuromodulation

EXPERIMENTAL

Neuromodulation every day, for 3 weeks

Device: Neuromodulation

Interventions

Neuromodulation DEVICE

Neuromodulation by UCon

Neuromodulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with PGAD

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud Unversity Medical Center

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 24, 2025
• Study Start: April 26, 2023
• Primary Completion: February 20, 2025
• Study Completion: April 22, 2025
• Last Updated: April 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)