Pudendal NeuralgiaSTIMCONENCT02564172
Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia
A study testing CMS group and OMM group in people with Pudendal Neuralgia, run by Nantes University Hospital at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pudendal Neuralgia
- What is being tested?
- CMS group and OMM group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesFrance
- Study dates
- 30 Sep 2015to 11 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Average or maximum pain experienced greater than or equal to 50/100 on a visual analogue scale (average of data collected 7 days prior to the inclusion visit and recorded by the patient on the clinical diary)
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
- Suffering from another neuropathic pain, or chronic pain, cancer, diabetic neuropathy
- Patient with cardiac sentry stimulator or planned to be implanted with one
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Bordeaux University Hospital
Bordeaux, 33000
Colmar Hospital
Colmar, 68024
Lille University Hospital
Lille, 59037
Lyon University Hospital
Lyon, 69003
Nantes Hospital
Nantes, Pays de la Loire Region, 44093
Clinic Catherine de Sienne
Nantes, 44200
Hôpital Foch
Suresnes, 92151
About this study
Official title: Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.
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.
Read more
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.
Read the 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
- Being tested
- CMS group, OMM group
- Medical subject headings
- Pudendal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMS groupDevice
Also called Conus medullaris stimulation with pentapolar lead plus optimal medical management.
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).
OMM groupOther
Also called Optimal Medical Management alone.
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.
| Study group | Role | What they receive |
|---|---|---|
| CMS group | Experimental | Conus medullaris stimulation with pentapolar surgical lead plus optimal medical management. Receives: Device: CMS group |
| OMM group | Active comparator | Optimal medical management alone. Receives: Other: OMM group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months of follow-up
Secondary outcomes (13)
Improvement of the sitting time, as measured from baseline to 12 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.
Measured: 12 months
Improvement of the sitting time, as measured from baseline to 3 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.
Measured: 3 months
Improvement of the sitting time, as measured from baseline to 1 month 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.
Measured: 1 month
Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up.
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.
Measured: 12 months
Pain relief (visual analogic scale), as measured from baseline to 6 months of follow-up.
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.
Measured: 6 months
Pain relief (visual analogic scale), as measured from baseline to 3 months of follow-up.
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.
Measured: 3 months
Pain relief (visual analogic scale), as measured from baseline to 1 month of follow-up.
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.
Measured: 1 month
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 12 months of follow-up.
health-related quality of life
Measured: 12 months
Use of pain treatment
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.
Measured: 12 months
Use of pain treatment
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.
Measured: 6 months
Use of pain treatment
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.
Measured: 3 months
Use of pain treatment
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.
Measured: 1 month
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 6 months of follow-up
health-related quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start30 Sep 2015
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pudendal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BUFFENOIR Kevin, Professor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564172
- Sponsor's protocol ID
- RC15_0075
- Acronym
- STIMCONE
- Status last verified
- Jan 2024
- First submitted
- 25 Sep 2015
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conus Medullaris Stimulation With 5 Columns Lead Versus Medical Treatment in Refractory Pudendal Neuralgia: a Randomized, Open, Controlled, Multicenter Trial.
- ClinicalTrials.gov ID
- NCT02564172
- Acronym / sponsor ID
- STIMCONE / RC15_0075
- Conditions
- Pudendal Neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMS group | Experimental | Device: CMS groupConus medullaris stimulation with pentapolar surgical lead plus optimal medical management. |
| OMM group | Active comparator | Other: OMM groupOptimal medical management alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Average or maximum pain experienced greater than or equal to 50/100 on a visual analogue scale (average of data collected 7 days prior to the inclusion visit and recorded by the patient on the clinical diary)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMS groupAlso: Conus medullaris stimulation with pentapolar lead plus optimal medical management.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). | Device | CMS group |
| OMM groupAlso: Optimal Medical Management alone.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. | Other | OMM group |
Primary outcome
Improvement of the sitting time from baseline to 6 months of follow-up
Time frame: 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.
13 secondary outcomes
Improvement of the sitting time, as measured from baseline to 12 months of follow-up.
Time frame: 12 months
Improvement of the sitting time, as measured from baseline to 3 months of follow-up.
Time frame: 3 months
Improvement of the sitting time, as measured from baseline to 1 month of follow-up.
Time frame: 1 month
Pain relief (visual analogic scale), as measured from baseline to 12 months of follow-up.
Time frame: 12 months
Pain relief (visual analogic scale), as measured from baseline to 6 months of follow-up.
Time frame: 6 months
Pain relief (visual analogic scale), as measured from baseline to 3 months of follow-up.
Time frame: 3 months
Pain relief (visual analogic scale), as measured from baseline to 1 month of follow-up.
Time frame: 1 month
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 12 months of follow-up.
Time frame: 12 months
Use of pain treatment
Time frame: 12 months
Use of pain treatment
Time frame: 6 months
Use of pain treatment
Time frame: 3 months
Use of pain treatment
Time frame: 1 month
Euro Quality of Life-5 Dimension Health questionnaire, as measured from baseline to 6 months of follow-up
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BUFFENOIR Kevin, Professor principal investigator
Nantes University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMS group and OMM group in people with Pudendal Neuralgia, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the sitting time from baseline to 6 months of follow-up (time frame: At 6 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.