Neuromodulation of the Dorsal Genital Nerve in Persistent Genital Arousal Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Symptom severity
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with PGAD
排除标准
- •Women < 18 years
- •Women not able to handle the neuromodulator
- •Women in whom the anatomy of the genitals precludes proper electrode placement
结局指标
主要结局
Symptom severity
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))