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

NCT03880786 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-03-04

No results posted yet for this study

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.

Conditions

  • Pudendal Impingement Syndrome

Interventions

DEVICE

pudendal PNE test lead

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.

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Principal Investigators

  • Katleen Jottard, MD · CHU Brugmann

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2021-11-09
Completion
2021-11-09

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03880786 on ClinicalTrials.gov