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

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ClinicalTrials.gov Identifier: NCT03880786
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Katleen JOTTARD, Brugmann University Hospital

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.


Condition or disease Intervention/treatment Phase
Pudendal Impingement Syndrome Device: pudendal PNE test lead Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Implantation of a Pudendal PNA Test Lead for Neuromodulation by the ENTRAMI Technique in Case of Chronic Perineal Pain Syndrome.
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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.




Primary Outcome Measures :
  1. Maximum Visual Analog Pain scores (VAS) [ Time Frame: Change from baseline at first postoperative day ]
    Linear scale raging from 0 (no pain) to 10 (maximal pain).

  2. Maximum VAS pain scores [ Time Frame: Change from baseline at three weeks of stimulation ]
    Linear scale raging from 0 (no pain) to 10 (maximal pain).

  3. Wexner constipation score [ Time Frame: Change from baseline at three weeks of stimulation ]
    Score computed according to a questionnaire. Score raging form 0 (normal) to 30 (severe constipation)

  4. Fecal incontinence severity index [ Time Frame: Change from baseline at three weeks of stimulation ]
    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.

  5. Quality of life assessed by the SF-36 questionnaire [ Time Frame: Change from baseline at three weeks of stimulation ]
    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).

  6. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR ) [ Time Frame: Change from baseline at three weeks of stimulation ]
    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.

  7. Brief Male Sexual Function Inventory (BSFI) [ Time Frame: Change from baseline at three weeks of stimulation ]
    The BSFI questionnaire measures male sexual function.Scores range from 0 (unsatisfactory) to 44 (satisfactory)

  8. Female sexual function index (FSFI) [ Time Frame: Change from baseline at three weeks of stimulation ]
    The FSFI is a brief questionnaire measure of sexual functioning in women. Scores range from 2 (unsatisfactory) to 36 (satisfactory).

  9. Patient Health Questionnaire Mood Scale (PHQ-9) [ Time Frame: Change from baseline at three weeks of stimulation ]
    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).

  10. Score on the DN4 questionnaire [ Time Frame: Change from baseline at three weeks of stimulation ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880786


Contacts
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Contact: Katleen Jottard, MD 3224754314 Katleen.JOTTARD@chu-brugmann.be

Locations
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Belgium
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Katleen Jottard, MD    3224754314    Katleen.JOTTARD@chu-brugmann.be   
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: Katleen Jottard, MD CHU Brugmann

Publications:

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Responsible Party: Katleen JOTTARD, Deputy Head of Clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03880786     History of Changes
Other Study ID Numbers: CHUB-ENTRAMI
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes