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

NACompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

October 11, 2023

Study Completion Date

October 11, 2023

Conditions
Pudendal Neuralgia
Interventions
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."

Trial Locations (7)

33000

Bordeaux University Hospital, Bordeaux

44093

Nantes Hospital, Nantes

44200

Clinic Catherine de Sienne, Nantes

59037

Lille University Hospital, Lille

68024

Colmar Hospital, Colmar

69003

Lyon University Hospital, Lyon

92151

Hôpital Foch, Suresnes

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT02564172 - Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia | Biotech Hunter | Biotech Hunter