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Completed

NCT Number: NCT03880786

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.

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Key information

Conditions

Pudendal Impingement Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pudendal PNE test lead

Device

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2019
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.