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

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

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.

Study Overview

• Status: Completed
• Conditions: Pudendal Impingement Syndrome
• Intervention / Treatment: Device: pudendal PNE test lead

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PNE test lead

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Visual Analog Pain scores (VAS)	Linear scale raging from 0 (no pain) to 10 (maximal pain).	Change from baseline at first postoperative day
Maximum VAS pain scores	Linear scale raging from 0 (no pain) to 10 (maximal pain).	Change from baseline at three weeks of stimulation
Wexner constipation score	Score computed according to a questionnaire. Score raging form 0 (normal) to 30 (severe constipation)	Change from baseline at three weeks of stimulation
Fecal incontinence severity index	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.	Change from baseline at three weeks of stimulation
Quality of life assessed by the SF-36 questionnaire	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).	Change from baseline at three weeks of stimulation
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR )	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.	Change from baseline at three weeks of stimulation
Brief Male Sexual Function Inventory (BSFI)	The BSFI questionnaire measures male sexual function.Scores range from 0 (unsatisfactory) to 44 (satisfactory)	Change from baseline at three weeks of stimulation
Female sexual function index (FSFI)	The FSFI is a brief questionnaire measure of sexual functioning in women. Scores range from 2 (unsatisfactory) to 36 (satisfactory).	Change from baseline at three weeks of stimulation
Patient Health Questionnaire Mood Scale (PHQ-9)	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).	Change from baseline at three weeks of stimulation
Score on the DN4 questionnaire	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.	Change from baseline at three weeks of stimulation

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Katleen Jottard, MD, CHU Brugmann

Publications and helpful links

General Publications

• Beco J, Climov D, Bex M. Pudendal nerve decompression in perineology: a case series. BMC Surg. 2004 Oct 30;4:15. doi: 10.1186/1471-2482-4-15.
• Robert R, Labat JJ, Bensignor M, Glemain P, Deschamps C, Raoul S, Hamel O. Decompression and transposition of the pudendal nerve in pudendal neuralgia: a randomized controlled trial and long-term evaluation. Eur Urol. 2005 Mar;47(3):403-8. doi: 10.1016/j.eururo.2004.09.003.
• Possover M. Laparoscopic management of endopelvic etiologies of pudendal pain in 134 consecutive patients. J Urol. 2009 Apr;181(4):1732-6. doi: 10.1016/j.juro.2008.11.096. Epub 2009 Feb 23.
• Heinze K, Hoermann R, Fritsch H, Dermietzel R, van Ophoven A. Comparative pilot study of implantation techniques for pudendal neuromodulation: technical and clinical outcome in first 20 patients with chronic pelvic pain. World J Urol. 2015 Feb;33(2):289-94. doi: 10.1007/s00345-014-1304-7. Epub 2014 Apr 29.
• Peters KM, Killinger KA, Jaeger C, Chen C. Pilot Study Exploring Chronic Pudendal Neuromodulation as a Treatment Option for Pain Associated with Pudendal Neuralgia. Low Urin Tract Symptoms. 2015 Sep;7(3):138-42. doi: 10.1111/luts.12066. Epub 2014 Jul 8.
• Ploteau S, Robert R, Bruyninx L, Rigaud J, Jottard K. A new endoscopic minimal invasive approach for pudendal nerve and inferior cluneal nerve neurolysis: An anatomical study. Neurourol Urodyn. 2018 Mar;37(3):971-977. doi: 10.1002/nau.23435. Epub 2017 Oct 26.
• Jottard K, Bonnet P, Bruyninx L, Ploteau S, De Wachter S. The ENTRAMI technique: Endoscopic transgluteal minimal invasive technique for implantation of a pudendal electrode under full visual control: A cadaver study. Neurourol Urodyn. 2019 Jan;38(1):130-134. doi: 10.1002/nau.23850. Epub 2018 Oct 12.
• Jottard K, Bruyninx L, Bonnet P, Mathieu N, De Wachter S. Pilot study: pudendal neuromodulation combined with pudendal nerve release in case of chronic perineal pain syndrome. The ENTRAMI technique: early results. Int Urogynecol J. 2021 Oct;32(10):2765-2770. doi: 10.1007/s00192-020-04565-1. Epub 2020 Oct 13.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): November 9, 2021
• Study Completion (Actual): November 9, 2021

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: CHUB-ENTRAMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No