NCT02564172

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

Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this national multicenter prospective open label trial, patients will be randomized 1:1 to experimental group (CMS group : Conus Medullaris Stimulation using pentapolar surgical lead, plus optimal medical management) or to control group (OMM group : optimal medical management alone) and followed for 12 months, in intention to treat. 42 patients suffering of refractory pudendal neuralgia will be included. Optimal medical management will be prescribed by algologists in both groups according to patient pain relief.

Conditions

• Pudendal Neuralgia

Interventions

Type	Name	Description
DEVICE	CMS group	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).
OTHER	OMM group	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.

Timeline

• Start date: 2015-09-30
• Primary completion: 2023-10-11
• Completion: 2023-10-11
• First posted: 2015-09-30
• Last updated: 2024-01-23

Locations

7 sites across 1 country: France