Pilot study: pudendal neuromodulation combined with pudendal nerve release in case of chronic perineal pain syndrome. Th

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ORIGINAL ARTICLE

Pilot study: pudendal neuromodulation combined with pudendal nerve release in case of chronic perineal pain syndrome. The ENTRAMI technique: early results Katleen Jottard 1

&

Luc Bruyninx 1 & Pierre Bonnet 2 & Nathalie Mathieu 3 & Stefan De Wachter 4,5

Received: 20 August 2020 / Accepted: 2 October 2020 # The International Urogynecological Association 2020

Abstract Introduction and hypothesis Chronic perineal pain syndrome due to pudendal nerve impingement is difficult to diagnose and to treat. All the known treatment options leave room for improvement considering the outcome. Early neuromodulation of the pudendal nerve after its surgical release could improve outcomes. Objectives The aim of the study was to evaluate the potential beneficial effect of pudendal neuromodulation combined with release surgery using the ENTRAMI technique (endoscopic transgluteal minimally invasive technique). Study design This is a single-center prospective descriptive study. Between March 2019 and March 2020, 16 patients (2 males, 14 females) were included. Data were collected at baseline and 1 month after surgery. Methods Patients eligible for inclusion had chronic perineal pain for at least 3 months in the area served by the pudendal nerve. We combined pudendal nerve release with neuromodulation. Results At 1 month, the numeric pain rating scale (NPRS) dropped from 9.5 at baseline to 3.5 (p = 0.003). Seventy-six percent of patients showed a global impression of change (PGIC) of > 50% at 1 month, and optimal treatment response (PGIC ≥ 90%) was found in 41% of patients. Limitations The drawback of our study was that it was not randomized or blinded. The peripheral nerve evaluation lead (PNE) used could only be implanted for 1 month because of infection risk and is also prone to dislocations and technical failures. Conclusion Pudendal nerve liberation by the ENTRAMI technique combined with short-term pudendal neuromodulation seems feasible and promising in treating patients with chronic perineal pain. Clinical trial number: NCT03880786. Keywords Perineal pain . Pudendal . Neuromodulation . Surgery

Introduction Chronic perineal pain syndrome due to pudendal nerve impingement is not just difficult to diagnose, but also to treat.

Treatment options for these patients are limited. Besides pharmacological and behavioral treatment, pudendal infiltrations can be offered. These have proven good short-term effects, but lack efficacy at the long term [1]. Pudendal nerve release

All authors approved the manuscript and this submission. The ethics committee of the Centre Hospitalier Universitaire-Universitair verpleegcentrum Brugmann (CHU-UVC Brugmann) approved the protocol (EC number: CE2019/09). * Katleen Jottard [email protected] 1

2

Department of Surgery, CHU Brugmann, Arthur Van Gehuchtenplaats 4, 1020 Brussels, Belgium Department of Urology and Department of Anatomy, CHU Sart-Tilman, Liège, Belgium

3

Department of Anesthesiology, Pain Clinic, Brugmann Hospital, Brussels, Belgium

4

Department of Urolo