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

Not Applicable

Completed

• Conditions: Pudendal Neuralgia
• Interventions: Other: OMM group; Device: CMS group

• Registration Number: NCT02564172
• Lead Sponsor: Nantes University Hospital

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.

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.

Study Timeline

• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-09-28
• Study Start: 2015-09-30
• Study First Posted: 2015-09-30
• Primary Completion: 2023-10-11
• Study Completion: 2023-10-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMM group	OMM group	Optimal medical management alone.
CMS group	CMS group	Conus medullaris stimulation with pentapolar surgical lead plus optimal medical management.

Primary Outcome Measures

Name	Time	Method
Improvement of the sitting time from baseline to 6 months of follow-up	At 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.

Secondary Outcome Measures

Name	Time	Method
Improvement of the sitting time, as measured from baseline to 12 months of follow-up.	12 months	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.
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 12 months of follow-up.	12 months	health-related quality of life
Improvement of the sitting time, as measured from baseline to 1 month of follow-up.	1 month	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.
Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up.	12 months	Visual analogic scale is recorded in a diary, which patient will complete two times per day, once in the morning and once in the evening during one week before clinical visit.
Pain relief (visual analogic scale), as measured from baseline to 6 months of follow-up.	6 months	Visual analogic scale is recorded in a diary, which patient will complete two times per day, once in the morning and once in the evening during one week before clinical visit.
Pain relief (visual analogic scale), as measured from baseline to 1 month of follow-up.	1 month	Visual analogic scale is recorded in a diary, which patient will complete two times per day, once in the morning and once in the evening during one week before clinical visit.
Improvement of the sitting time, as measured from baseline to 3 months of follow-up.	3 months	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.
Use of pain treatment	1 month	Use of antiepileptics and of antidepressants and of analgesics OMS level I, II or III will be recorded and percentage of their variation between visits analysed.; Use of non drugs therapies will be reported for descripton only.
Pain relief (visual analogic scale), as measured from baseline to 3 months of follow-up.	3 months	Visual analogic scale is recorded in a diary, which patient will complete two times per day, once in the morning and once in the evening during one week before clinical visit.
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 6 months of follow-up	6 months	health-related quality of life

Trial Locations

Locations (7)

Colmar Hospital; 🇫🇷 Colmar, France

Lyon University Hospital; 🇫🇷 Lyon, France

Nantes Hospital; 🇫🇷 Nantes, Pays De La Loire, France

Lille University Hospital; 🇫🇷 Lille, France

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Clinic Catherine de Sienne; 🇫🇷 Nantes, France

Hôpital Foch; 🇫🇷 Suresnes, France