Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study: Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.

Conditions
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Pudendal Impingement Syndrome

Intervention / Treatment
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* Device: pudendal PNE test lead


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for release surgery Patients meeting the five Nantes criteria Chronic pain for more than 3 months Exclusion Criteria: Pregnancy Progressive neurological disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PNE test lead<br> | Device: pudendal PNE test lead<br>* All patients eligible for release surgery will be implanted a PNE test lead (Medtronic) which will be placed (transforaminal or transgluteally) next to the pudendal nerve, at the level of the ischial spine, after surgical release and connected to an external stimulation device. The PNE lead will be fixed at the ischial-spinal ligament with an absorbable suture to prevent dislocation. If a bilateral dissection is needed, bilateral test leads will be placed. Stimulation will be switched on at the second postoperative day, according to the sensory threshold described by the patient. After three weeks the PNE test lead will be removed at the outpatient clinical visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Visual Analog Pain scores (VAS) | Linear scale raging from 0 (no pain) to 10 (maximal pain). | Change from baseline at first postoperative day | 
| Maximum VAS pain scores | Linear scale raging from 0 (no pain) to 10 (maximal pain). | Change from baseline at three weeks of stimulation | 
| Wexner constipation score | Score computed according to a questionnaire. Score raging form 0 (normal) to 30 (severe constipation) | Change from baseline at three weeks of stimulation | 
| Fecal incontinence severity index | 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. | Change from baseline at three weeks of stimulation | 
| Quality of life assessed by the SF-36 questionnaire | 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). | Change from baseline at three weeks of stimulation | 
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR ) | 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. | Change from baseline at three weeks of stimulation | 
| Brief Male Sexual Function Inventory (BSFI) | The BSFI questionnaire measures male sexual function.Scores range from 0 (unsatisfactory) to 44 (satisfactory) | Change from baseline at three weeks of stimulation | 
| Female sexual function index (FSFI) | The FSFI is a brief questionnaire measure of sexual functioning in women. Scores range from 2 (unsatisfactory) to 36 (satisfactory). | Change from baseline at three weeks of stimulation | 
| Patient Health Questionnaire Mood Scale (PHQ-9) | 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). | Change from baseline at three weeks of stimulation | 
| Score on the DN4 questionnaire | 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. | Change from baseline at three weeks of stimulation |