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

Not Applicable

Completed

• Conditions: Pudendal Impingement Syndrome
• Interventions: Device: pudendal PNE test lead

• Registration Number: NCT03880786
• Lead Sponsor: Brugmann University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-08
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-19
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PNE test lead	pudendal PNE test lead	-

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire Mood Scale (PHQ-9)	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	Change from baseline at three weeks of stimulation	Linear scale raging from 0 (no pain) to 10 (maximal pain).
Wexner constipation score	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	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	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)	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 )	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)	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)	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	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).

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium