Clinical trial NCT03880786: Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.
Official title: Pilot Study: Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pudendal Impingement Syndrome
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Visual Analog Pain scores (VAS)
timeFrame: Change from baseline at first postoperative day
measure: Maximum VAS pain scores
timeFrame: Change from baseline at three weeks of stimulation
measure: Wexner constipation score
timeFrame: Change from baseline at three weeks of stimulation
measure: Fecal incontinence severity index
timeFrame: Change from baseline at three weeks of stimulation
measure: Quality of life assessed by the SF-36 questionnaire
timeFrame: Change from baseline at three weeks of stimulation
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR )
timeFrame: Change from baseline at three weeks of stimulation
measure: Brief Male Sexual Function Inventory (BSFI)
timeFrame: Change from baseline at three weeks of stimulation
measure: Female sexual function index (FSFI)
timeFrame: Change from baseline at three weeks of stimulation
measure: Patient Health Questionnaire Mood Scale (PHQ-9)
timeFrame: Change from baseline at three weeks of stimulation
measure: Score on the DN4 questionnaire
timeFrame: Change from baseline at three weeks of stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Katleen Jottard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.