Recommendations on the management of pudendal nerve entrapment syndrome: A formalised expert consensus.

BACKGROUND: Since the development and publication of diagnostic criteria for pudendal nerve entrapment (PNE) syndrome in 2008, no comprehensive work has been published on the clinical knowledge in the management of this condition. The aim of this work was to develop recommendations on the diagnosis and the management of PNE. METHODS: The methodology of this study was based on French High Authority for Health Method for the development of good practice and the literature review was based on the PRISMA method. The selected articles have all been evaluated according to the American Society of Interventional Pain Physicians assessment grid. RESULTS: The results of the literature review and expert consensus are incorporated into 10 sections to describe diagnosis and management of PNE: (1) diagnosis of PNE, (2) patients advice and precautions, (3) drugs treatments, (4) physiotherapy, (5) transcutaneous electrostimulations (TENS), (6) psychotherapy, (7) injections, (8) surgery, (9) pulsed radiofrequency, and (10) Neuromodulation. The following major points should be noted: (i) the relevance of 4+1 Nantes criteria for diagnosis; (ii) the preference for initial monotherapy with tri-tetracyclics or gabapentinoids; (iii) the lack of effect of opiates, (iv) the likely relevance (pending more controlled studies) of physiotherapy, TENS and cognitive behavioural therapy; (v) the incertitudes (lack of data) regarding corticoid injections, (vi) surgery is a long term effective treatment and (vii) radiofrequency needs a longer follow-up to be currently proposed in this indication. CONCLUSION: These recommendations should allow rational and homogeneous management of patients suffering from PNE. They should also allow to shorten the delays of management by directing the primary care. SIGNIFICANCE: Pudendal nerve entrapment (PNE) has only been known for about 20 years and its management is heterogeneous from one practitioner to another. This work offers a synthesis of the literature and international experts' opinions on the diagnosis and management of PNE.

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

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.

Treatment of Fecal Incontinence With a Rechargeable Sacral Neuromodulation System: Efficacy, Clinical Outcome, and Ease of Use-Six-Month Follow-Up.

OBJECTIVE: Sacral neuromodulation is an effective treatment for fecal incontinence (FI) after conservative treatments have failed. A new rechargeable sacral neuromodulation system (r-SNM) includes a rechargeable implantable neurostimulator (INS). No data is available of the use of this technology in patients with fecal incontinence. MATERIALS AND METHODS: Fifteen patients with FI were implanted with the Axonics rechargeable SNM system in a single-stage implant procedure and prospectively followed. Primary outcome was fecal incontinence episodes at four weeks and six months measured with stools diary. Success was defined as at least 50% improvement of fecal incontinence episodes. Additionally, quality of life and ease of use were evaluated. RESULTS: At four weeks, 13 participants (87%) were test responders based on ≥50% reduction in FI episodes as documented on their bowel diary. Weekly FI episodes decreased from a median (25%-75% range) of 8 (5.8-20.3) at baseline to a median of 1.5 (0.4-4.5) at four weeks (p = 0.001), and 1.5 (0-2.6) at six months (p = 0.001), corresponding to 75% and 79% reduction in weekly FI episodes. Of the 13 subjects having ≥50% reduction in FI episodes at four weeks, 12 (PP = 92%) were therapy responders at six months. There were no unanticipated device or procedure-related adverse events. Mean time to recharge the system was 37 ± 3 min once or twice per week. All patients were moderately or very satisfied with the system and its effect. CONCLUSIONS: The r-SNM system provides safe and effective therapy in patients with FI at six months.

Endoscopic trans gluteal minimal-invasive approach for nerve liberation (ENTRAMI technique) in case of pudendal and/or cluneal neuralgia by entrapment: One-year follow-up.

BACKGROUND: Chronic neuropathic perineal pain syndrome is a collective term that encompasses several diagnoses. In patients where the neuropathic pain syndrome is caused by pudendal or cluneal nerve entrapment, surgical release can be proposed if other measures have failed. The aim of this study is to evaluate the clinical outcome of patients suffering from pudendal and/or cluneal nerve entrapment at 1 year after this minimal invasive surgery, which is based on the open trans gluteal approach who has proven its efficacy compared to medical treatment in a randomized control trial. METHODS: Patients eligible for inclusion had chronic perineal neuropathic pain for at least 3 months in the area served by the pudendal and/or cluneal nerve, refractory to conservative measurements. Patients met all five of the Nantes criteria. RESULTS: Fifteen patients underwent the ENTRAMI technique. At 1 year after surgery, overall reduction of the average maximal Numeric Pain rating Scale (NPRS-score) was from 9 (range, 7-10) at baseline to 5 (range, 0-10; P-value <.05). At 1 year 73% of patients declared to have a "good treatment response" (patient global impression of change [PGIC] >30%) and optimal treatment response (PGIC ≥90%) was found in 40% (P-value <.05). No complications were recorded. CONCLUSION: This study clearly shows that the technique is feasible with promising long-term results in a difficult to manage patient group.

A minimally invasive, endoscopic transgluteal procedure for pudendal nerve and inferior cluneal nerve neurolysis in case of entrapment: 3- and 6-month results. The ENTRAMI technique for neurolysis.

BACKGROUND: Pudendal and cluneal nerve entrapment can cause a neuropathic pain syndrome in the sensitive areas innervated by these nerves. Recently, a new endoscopic minimal invasive approach for pudendal and inferior cluneal nerve neurolysis has been published in a cadaver study. The aim of our study was to describe the feasibility of this new approach and to evaluate the clinical outcome. METHODS: Fifteen patients underwent the ENTRAMI technique. The Numeric Pain Rating Scale (NPRS) and Patient Global Impression of Change (PGIC) were recorded at baseline and at 3 and 6 months after surgery. RESULT: The average duration of intervention (skin to skin) was 139 min (range 50-270 min) for bilateral pudendal neurolysis and/or cluneal neurolysis and 113 min (range 100-130 min) for unilateral pudendal and/or cluneal neurolysis. No perioperative blood loss occurred. At 3 months, 50% of patients declared a more than 30% improvement of their PGIC, increasing to 57% at 6 months; 31% reported more than 90% improvement of PGIC at 6 months. Overall reduction of the average maximal NPRS score was from 9 (range 7-10) to 6 at 3 months (range 0-10; p value < 0.05) and to 5 at 6 months (range 0-10; p value < 0.05). There were no postoperative complications. CONCLUSIONS: The ENTRAMI technique is feasibly in patients suffering from pudendal and/or cluneal neuralgia and preliminary results are promising. CLINICAL TRIAL NUMBER: NCT03883178.

The ENTRAMI technique: Endoscopic transgluteal minimal invasive technique for implantation of a pudendal electrode under full visual control: A cadaver study.

AIM: The aim of this article is to describe a minimal invasive trans gluteal endoscopic approach to implant a pudendal electrode for neuromodulation under full visual control. METHODS: Eight trans gluteal approaches were performed on four cadavers. The sacral transforaminal percutaneous technique was performed to implant the electrode. The electrode was then picked up and placed under visual control next to the pudendal nerve. RESULTS: The first trocar was placed in the upper lateral quadrant of the gluteal region. The 0° optical system was used to help with the pneumodissection to identify the sciatic nerve. At that point a second 3 mm trocar was placed to insert a dissecting grasping forceps. In some cases, a second 3 mm trocar was placed. A step by step dissection, based on anatomical findings, was necessary to be able to locate the pudendal nerve. The electrode, which was placed percutaneously and transforaminal through S3 or S4, was picked up and placed under full visual control next to the pudendal nerve, slightly entering the Alcock's canal. The electrode was placed in an ideal manner, meaning that all 4-contact points of the electrode are in parallel and in contact with the targeted nerve. The electrode was fixed in that ideal position at the level of the sacrospinous ligament. After placement of that electrode, an X-ray of the pelvic area was done. CONCLUSIONS: The ENTRAMI technique allows optimal pudendal electrode placement under full visual control and should now be tested in a clinical setting.

A new endoscopic minimal invasive approach for pudendal nerve and inferior cluneal nerve neurolysis: An anatomical study.

AIM: To describe a new minimal invasive approach of the gluteal region which will permit to perform neurolysis of the pudendal and cluneal nerves in case of perineal neuralgia due to an entrapment of these nerve trunks. METHOD: Ten transgluteal approaches were performed on five cadavers. Relevant anatomic structures were dissected and further described. Neurolysis of the pudendal nerve or cluneal nerves were performed. Landmarks for secure intraoperative navigation were indicated. RESULTS: The first operative trocar for the camera was inserted with regards to the iliac crest in the deep gluteal space. With the aid of pneumodissection, the infragluteal plane was dissected. The piriformis muscle was identified as well as the sciatic and the posterior femoral cutaneous nerve. Consequently, the sciatic tuberosity was visualized together with the cluneal nerves. Hereafter, the second trocar was introduced caudal to the first one and placed on an horizontal line passing at the level of the coccyx, allowing access to the ischial spine and the visualization of the pudendal nerve and vessels. A third 5 mm trocar was then inserted medial from the first one, permitting to dissect and transsect the sacrospinous ligament. The pudendal nerve was subsequently transposed and followed on its course in the pudendal channel. CONCLUSIONS: A reliable exploration of the gluteal region including identification of the sciatic, pudendal, and posterior femoral cutaneous nerves is feasible using a minimal invasive transgluteal procedure. Consequently, the transposition of the pudendal nerve and the liberation of the cluneal nerves can be performed.

Selection criteria for surgical treatment of pudendal neuralgia.

AIMS: Pudendal neuralgia is the clinical expression of a chronic compression of the pudendal nerve. The diagnosis is based on a set of five criteria, called Nantes criteria. Four of the criteria are clinical and the last requires evaluation of the anesthetic response to CT-guided infiltration of the pudendal nerve. The aim of our study is to evaluate the relevance of anesthetic test response to select patients for surgery, and whether this criterion can be used to predict its success. METHODS: Retrospective analysis of a cohort of 34 patients undergoing surgical treatment. In our cohort, we included six patients with negative CT-guided pudendal nerve infiltration test. RESULTS: Of the 28 patients that met all five Nantes criteria, 64% (18 patients) responded well to surgery. In contrast, 100% of the six patients with a negative anesthetic test failed to show an amelioration of symptoms after surgical treatment (P = 0.006). In our analysis, there was no significant difference in surgery response when men were compared to women (P = 0.387), when procedure was unilateral or bilateral (P = 0.562), or when duration of symptoms was long (P = 0.412). We observed a difference in terms of age between the group of responders and non-responders, although this difference did not reach the threshold of significance (P = 0.216). CONCLUSIONS: The selection of candidates for surgery should always include a single diagnostic anesthetic injection of the pudendal nerve, as the fifth of the Nantes criteria is an effective predictor of the success of surgery. Neurourol. Urodynam. 36:663-666, 2017. © 2016 Wiley Periodicals, Inc.

Different surgical strategies in the treatment of familial adenomatous polyposis: what's the role of the ileorectal anastomosis?

Prophylactic (procto-) colectomy is the treatment of choice to reduce the risk of colorectal cancer in FAP patients with multiple adenomas. Because patients present at young age, rectum-sparing surgery is sometimes advocated, so that there is no pelvic dissection with impact on quality of life, preserved pelvic innervation and sexual function and fertility. The main disadvantage of a total colectomy with an ileorectal anastomosis (IRA) is a rectal cancer risk of 50% at the age of 50 years and a cumulative risk of 25.8% after 25 years of follow-up. Therefore, this procedure should be reserved for patients with an unaffected rectum. There should be no discussion to perform a primary IPAA in patients with multiple rectal adenomas (> 20) or those with a severe dysplastic or large (> 3 cm) rectal adenoma or a cancer elsewhere in the colon. A patient with an IRA should undergo yearly follow-up by rectoscopy.