Pilot Study: Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire Mood Scale (PHQ-9)
研究概览
简要总结
Pudendal nerve release surgery in case of pudendal impingement syndrome is well described in literature.Pudendal nerve modulation in case of chronic perineal pain is also a promising technique and some small studies exist. However, in the latter group, patient inclusion criteria are very heterogenous and so conclusions about efficacy are difficult to draw. In the surgery group, outcome results also vary between the different approaches but in general, there is room for improvement. After pudendal nerve release in chronic perineal pain syndrome, it can take up to 6 months before improvement for the patient is recorded. This is partially due to the complex chronic pain syndrome mechanism.
Nothing is known about the possible effect of early neuromodulation at the level of the pudendal nerve after his release.
Recently, two cadaveric studies were published which described a minimal invasive trans gluteal approach for pudendal nerve decompression and a pudendal electrode placement.
In the present trial, the investigators would like to combine the endoscopic trans gluteal pudendal release with pudendal neuromodulation to improve the outcome for patients suffering from pudendal impingement syndrome.
The aim is to improve the results of pain score and quality of life of patients undergoing surgery for pudendal release in case of chronic perineal pain syndrome.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for release surgery
- •Patients meeting the five Nantes criteria
- •Chronic pain for more than 3 months
排除标准
- •Pregnancy
- •Progressive neurological disease
结局指标
主要结局
Patient Health Questionnaire Mood Scale (PHQ-9)
时间窗: Change from baseline at three weeks of stimulation
The purpose of QSP-9 is to gather information on the presence and intensity of depressive symptoms.Scores range from 0 (no depression) to 27 (severe depression).
Maximum VAS pain scores
时间窗: Change from baseline at three weeks of stimulation
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Wexner constipation score
时间窗: Change from baseline at three weeks of stimulation
Score computed according to a questionnaire. Score raging form 0 (normal) to 30 (severe constipation)
Fecal incontinence severity index
时间窗: Change from baseline at three weeks of stimulation
Score computed according to a questionnaire.Scores range from 0 to 61, where the higher the score, the higher the perceived severity of the fecal incontinence.
Score on the DN4 questionnaire
时间窗: Change from baseline at three weeks of stimulation
The DN4 (which stands for "Douleur Neuropathique 4") is one of the questionnaires that can be useful in diagnosing neuropathic pain. It ranges from 0 to 10. Values equal to superior to 4 give a diagnostic of neuropathic pain.
Maximum Visual Analog Pain scores (VAS)
时间窗: Change from baseline at first postoperative day
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR )
时间窗: Change from baseline at three weeks of stimulation
The PISQ-IR is a validated evaluation tool which can be used clinically as well as in research for assessment of female sexual function (FSF) in women with female pelvic floor disorders.
Female sexual function index (FSFI)
时间窗: Change from baseline at three weeks of stimulation
The FSFI is a brief questionnaire measure of sexual functioning in women. Scores range from 2 (unsatisfactory) to 36 (satisfactory).
Brief Male Sexual Function Inventory (BSFI)
时间窗: Change from baseline at three weeks of stimulation
The BSFI questionnaire measures male sexual function.Scores range from 0 (unsatisfactory) to 44 (satisfactory)
Quality of life assessed by the SF-36 questionnaire
时间窗: Change from baseline at three weeks of stimulation
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. It covers several health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.The recommended scoring system for the SF-36 is a weighted Likert system for each item. The items in the subscales are summed to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale of 0 (negative to health) to 100 (positive for health).
次要结局
未报告次要终点
研究者
Katleen JOTTARD
Deputy Head of Clinic
Brugmann University Hospital