Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia

NCT02564172 | Completed DMC

• 1 other identifier: RC15_0075
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 7

Brief Summary

Pudendal neuralgia is a frequent diagnosis in pain clinics. This perineal pain has devastating effects on patient's quality of life. Today, 30% of patients are refractory to pain management and surgical procedure. The neuropathic characteristics of the pain in these patients lead us to test the efficiency of spinal cord stimulation at conus medullaris level. In our published preliminary study involving 27 patients with refractory pudendal neuralgia, we demonstrated that 74% of patients implanted with stimulation electrodes at the conus medullaris responded to stimulation. The primary objective of the present trial is to assess through a randomized, parallel group design, the effectiveness of spinal cord stimulation at the conus medullaris using pentapolar surgical lead ((TM)Penta, St Jude medical ANS) versus medical treatment alone on sitting time in refractory pudendal neuralgia.

Conditions

Pudendal Neuralgia

Outcome Measures

Primary Outcomes (1)

• Improvement of the sitting time from baseline to 6 months of follow-up

  Sitting time is measured by a sitting time diary (in minutes) which patients will record during a daily activity, two times per day, once in the morning and once in the evening during one week before clinical visit.

  At 6 months of follow-up

Secondary Outcomes (13)

• Improvement of the sitting time, as measured from baseline to 12 months of follow-up.

  12 months

• Improvement of the sitting time, as measured from baseline to 3 months of follow-up.

  3 months

• Improvement of the sitting time, as measured from baseline to 1 month of follow-up.

  1 month

• Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up.

  12 months

• Pain relief (visual analogic scale), as measured from baseline to 6 months of follow-up.

  6 months

Study Arms (2)

CMS group

EXPERIMENTAL

Conus medullaris stimulation with pentapolar surgical lead plus optimal medical management.

Device: CMS group

OMM group

ACTIVE COMPARATOR

Optimal medical management alone.

Other: OMM group

Interventions

CMS group DEVICE

Conus medullaris stimulation with pentapolar surgical lead includes: * Pentapolar surgical lead implant ((TM)Penta lead from St Judes Medical ANS which is the medical device under study) * Test phase of 10 days according to HAS("Haute Autorité de Santé") recommendation * If test phase positive, the lead is kept and subcutaneous rechargeable generator is implanted. * If test phase negative, the lead is removed. Optimal medical management : Similarly to patients randomized in active comparator group, patients randomized in experimental group will also be prescribed optimized medical management (treatment for pain relief) under algologist control. (A decrease of the consumption of pain treatment should be observed if conus medullaris stimulation has a positive effect).

Also known as: Conus medullaris stimulation with pentapolar lead plus optimal medical management.

CMS group

OMM group OTHER

Optimal Medical Management (treatment for pain relief) includes analgesics and/or antidepressant and/or antiepileptics.Usually, drugs for neuropathic pain are prescribed as follows: * at effective dose, and minimal effective dose on the basis of adverse events and contraindications * as alone treatment in first and second line, then combination treatment. All this depends on the patient, on her/his pain, on her/his previous treatment. Medical treatment prescription will reviewed by algologist at each clinical visit. It is not possible in this indication to establish a standardized treatment. Non drugs therapies (physiotherapy, psychobehavioral approaches…) will not be forbidden or contra-indicated.

Also known as: Optimal Medical Management alone.

OMM group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evaluation by multidisciplinary team including neuro-surgeons, algologists and psychologists performed, (if not already done in the previous year for algologists and psychologists)
• Given informed consent.

You may not qualify if:

• Pregnant, or planning to become pregnant during the study (12months)
• Adults under guardianship or trusteeship
• Being treated or has been treated with spinal cord stimulation, subcutaneous or peripheral nerve stimulation, intrathecal drug delivery system.
• Had pudendal nerve decompression surgery less than 12 months ago
• Is suspected of substance abuse
• Has unresolved major issues of secondary gain
• Exhibits major psychiatric morbidity
• Has life expectancy inferior to 5 years
• Implant spinal cord stimulation surgery contraindication :
• Magnetic resonnance imaging contraindication
• History of coagulation disorder
• Severe immunodepression, systemic, due to medicine drug intake or not (AIDS, transplanted, under anti TNF alpha treatment, …)
• Current infection
• Would be unable to operate the spinal cord stimulation equipment, undergo the study assessments or complete questionnaires or clinical diary, based on the opinion of the investigator
• Unwilling to be treated with spinal cord stimulation, comply with study requirements.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (7)

Nantes Hospital

Nantes, Pays de la Loire Region, 44093, France

Location

Bordeaux University Hospital

Bordeaux, 33000, France

Location

Colmar Hospital

Colmar, 68024, France

Location

Lille University Hospital

Lille, 59037, France

Location

Lyon University Hospital

Lyon, 69003, France

Location

Clinic Catherine de Sienne

Nantes, 44200, France

Location

Hôpital Foch

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Pudendal Neuralgia

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• BUFFENOIR Kevin, Professor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 30, 2015
• Study Start: September 30, 2015
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

FR (7)