NCT03880786

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

Completed NA Last updated 4 March 2022

What this trial tests

NA trial testing pudendal PNE test lead in Pudendal Impingement Syndrome in 21 participants. Completed in 9 November 2021.

Timeline

8 January 2019

Primary endpoint
9 November 2021

9 November 2021

Quick facts

Lead sponsor	Brugmann University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	8 January 2019
Primary completion	9 November 2021
Estimated completion	9 November 2021
Sites	1 location across Belgium

Drugs / interventions tested

• pudendal PNE test lead

Conditions studied

• Pudendal Impingement Syndrome — all drugs for Pudendal Impingement Syndrome →

Sponsor

Brugmann University Hospital

Who can join

18 and older, any sex, with Pudendal Impingement Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pilot study: pudendal neuromodulation combined with pudendal nerve release in case of chronic perineal pain syndrome. The ENTRAMI technique: early results.
   Jottard K, Bruyninx L, Bonnet P, Mathieu N, et al · · 2021 · cited 6× · PMID 33048179 · DOI 10.1007/s00192-020-04565-1