Pelvic PainSCS/CPPNCT05373667
A Prospective Clinical Study to Assess the Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain
An observational study of Pelvic Pain, run by EPC Education s.r.o..
Trial summary
Prospective observational assessment of the efficacy of Spinal Cord Stimulation (SCS) treatment in patients with neuropathic pelvic pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Spinal Cord Stimulation (SCS)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 May 2025
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with chronic pelvic pain
Who may be able to join
- 1. Have a clinical diagnosis of chronic predominant pelvic pain as determined by a multidisciplinary study team.
- 2. Score 13 or greater in PainDETECT questionnaire 3. 4. Have been refractory to conservative therapy for a minimum of 3 months, including assessment of at least 2 different classes of medications.
- 5. Average pain intensity (over the last 7 days) of ≥ 5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment (in accordance with the NICE guidelines).
- 6. Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
- 7. Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion.
- 8. Be 18 years of age or older at the time of enrollment. 9. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
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- 10. Be capable of subjective evaluation, able to read and understand written questionnaires, and are able to read, understand and sign the written inform consent.
- 11. Be willing and capable of giving informed consent. 12. Be willing and able to comply with study-related requirements, procedures, and visits.
- 13. Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator
Who cannot join
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator (such as primary headache diagnosis or fibromyalgia).
- Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury as determined by the investigator.
- Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator.
- Significant stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by MRI conducted within the past 12 months.
- Have a clinical diagnosis of unstable mental health condition or severe depression [request input on this exclusion criteria from the psychologist] including suicidal ideation.
- Be benefitting within from an interventional procedure and/or surgery to treat chronic pelvic pain (Subjects should be enrolled at least 30 days from last benefit).
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- Have an existing drug pump and/or another active implantable device such as a pacemaker.
- Have failed other neuromodulation therapies including traditional SCS, peripheral nerve stimulation or dorsal root ganglion stimulation.
- Have metastatic malignant disease or active local malignant disease.
- Have a life expectancy of less than 1 year.
- Have an active systemic or local infection at the anticipated needle entry site.
- Be pregnant or plan to become pregnant during the study (participants of child-bearing potential that are sexually active must use a reliable form of birth control).
- Are currently nursing (if female).
- Have been immunocompromised.
- Have been known to be allergic or have shown hypersensitivity to any materials of the neurostimulation system which come in contact with the body.
- Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including opioids, benzodiazepines, alcohol and illicit drugs).
- Be concomitantly participating in another clinical study.
- Be involved in an injury claim under current litigation.
- Have a pending or approved worker's compensation claim.
- Presence of pelvic tumor including benign.
Trial locations and contacts
No sites are listed yet.
Nicolas Varela, MD, DESA contact
About this study
Prospective observational assessment of the efficacy of Spinal Cord Stimulation (SCS) treatment in patients with neuropathic pelvic pain.
Read the detailed description
The objective of a clinical trial is an assessment of the efficacy of Spinal Cord Stimulation (SCS) treatment in patients with localized (not widespread pain), predominant neuropathic pelvic pain neuropathic pain (determined by PAIN-DETECT and rule out musculature pain).
Etiologies of CPP to be studied include but not limited to vulvodynia, perineal pain, perianal pain, bladder pain syndrome, and pelvic pain resulting from colorectal procedures. Medical review of the subjects will be done by a multidisciplinary team consisting of urologists/ gynecologists, interventional pain physicians, and psychiatrists.
Enrolled centers are National Hospital For Neurology and Neurosurgery in London in the United Kingdom, EuroPainClinics® with centers in Bratislava, Košice, and Bardejov in the Slovac republic and also EuroPainClinics® with centers Praha, Brno, Ostrava, and Hradec Kralove in the Czech republic.
Lead placement:
To be determined as a function of pain distribution. Lead placement will be either retrograde or anterograde determined by the investigator.
Study Duration:
The expected duration of this study is approximately 12 months. Enrollment is expected to last 6 months, with subjects followed up to a 12 month period following permanent implant. The time commitment for a subject to complete the study is approximately 13 months; consisting of Baseline assessments, and last follow-up at 12 months.
Study Design:
This is a single-center, single-arm, prospective, observational post-market study to assess the safety and effectiveness of the Senza System in subjects with chronic pelvic pain. Subjects are acting as his/her own control. Data at follow-up visits will be compared to the subjects' baseline data.
Study Objective:
The objective of this observational study is to assess the safety and effectiveness of the Spinal cord stimulation, in the treatment of Chronic Pelvic Pain at the study follow-up visits at 1, 3, 6, 9 and 12 months.
- Conditions
- Pelvic Pain
- Being tested
- Spinal Cord Stimulation (SCS)
- Keywords
- Spinal cord Stimulation, Pelvic Pain
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation (SCS)Procedure or surgery
Spinal Cord Stimulation (SCS) - High Frequency at 10 kHz
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Measured: 1 month follow-up
Visual analog scale
Measured: 3 month follow-up
Visual analog scale
Measured: 6 month follow-up
Visual analog scale
Measured: 9 month follow-up
Visual analog scale
Measured: 12 month follow-up
Pain Disability Index
Measured: 1 month follow-up
Pain Disability Index
Measured: 3 month follow-up
Pain Disability Index
Measured: 6 month follow-up
Pain Disability Index
Measured: 9 month follow-up
Pain Disability Index
Measured: 12 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Measured: 1 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Measured: 3 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Measured: 6 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Measured: 9 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Measured: 12 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Measured: 1 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Measured: 3 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Measured: 6 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Measured: 9 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Measured: 12 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Measured: 1 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Measured: 3 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Measured: 6 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Measured: 9 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Measured: 12 month follow-up
Secondary outcomes (5)
Neurologic status
includes motor, sensory and reflex functions, which will be characterized as improved, maintained, or a deficit as compared with baseline status as follows:
- A clinically meaningful neurological and physical status improvement is defined as a significant persistent improvement in neurological function that impacts subject's well-being is attributable to a neurological finding; and is new or improved as compared with the baseline assessment.
- A clinically meaningful neurological deficit is defined as a stimulation-related significant persistent abnormality in neurological function that impacts subject's well-being is attributable to a neurological finding; and is new or worsened as compared with the baseline assessment.
- If neither a clinically meaningful neurological improvement nor a clinically meaningful neurological deficit is observed, then neurologic status is maintained.
Measured: 6 month follow-up
Neurologic status
includes motor, sensory and reflex functions, which will be characterized as improved, maintained, or a deficit as compared with baseline status as follows:
- A clinically meaningful neurological and physical status improvement is defined as a significant persistent improvement in neurological function that impacts subject's well-being is attributable to a neurological finding; and is new or improved as compared with the baseline assessment.
- A clinically meaningful neurological deficit is defined as a stimulation-related significant persistent abnormality in neurological function that impacts subject's well-being is attributable to a neurological finding; and is new or worsened as compared with the baseline assessment.
- If neither a clinically meaningful neurological improvement nor a clinically meaningful neurological deficit is observed, then neurologic status is maintained.
Measured: 12 month follow-up
Hospitalizations
compared to baseline history of previous 12 months
Measured: 12 month follow-up
Adverse events
Measured: 12 month follow-up
Medication usage
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Collaborators
- National Hospital for Neurology and Neurosurgery
- Responsible party
- Sponsor
- Investigators
- Róbert Rapcan, MD, PhD, MBA, FIPP, Study director, EPC Education s.r.o.Ladislav Kočan, MD, PhD, Study chair, EPC Education s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373667
- Sponsor's protocol ID
- NSM 1-129/2021
- Acronym
- SCS/CPP
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study to Assess the Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05373667
- Acronym / sponsor ID
- SCS/CPP / NSM 1-129/2021
- Conditions
- Pelvic Pain
- Keywords
- Spinal cord Stimulation, Pelvic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Collaborators
- National Hospital for Neurology and Neurosurgery
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 13 May 2022 (actual)
- 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.
Prospective observational assessment of the efficacy of Spinal Cord Stimulation (SCS) treatment in patients with neuropathic pelvic pain.
Detailed description
The objective of a clinical trial is an assessment of the efficacy of Spinal Cord Stimulation (SCS) treatment in patients with localized (not widespread pain), predominant neuropathic pelvic pain neuropathic pain (determined by PAIN-DETECT and rule out musculature pain).
Etiologies of CPP to be studied include but not limited to vulvodynia, perineal pain, perianal pain, bladder pain syndrome, and pelvic pain resulting from colorectal procedures. Medical review of the subjects will be done by a multidisciplinary team consisting of urologists/ gynecologists, interventional pain physicians, and psychiatrists.
Enrolled centers are National Hospital For Neurology and Neurosurgery in London in the United Kingdom, EuroPainClinics® with centers in Bratislava, Košice, and Bardejov in the Slovac republic and also EuroPainClinics® with centers Praha, Brno, Ostrava, and Hradec Kralove in the Czech republic.
Lead placement:
To be determined as a function of pain distribution. Lead placement will be either retrograde or anterograde determined by the investigator.
Study Duration:
The expected duration of this study is approximately 12 months. Enrollment is expected to last 6 months, with subjects followed up to a 12 month period following permanent implant. The time commitment for a subject to complete the study is approximately 13 months; consisting of Baseline assessments, and last follow-up at 12 months.
Study Design:
This is a single-center, single-arm, prospective, observational post-market study to assess the safety and effectiveness of the Senza System in subjects with chronic pelvic pain. Subjects are acting as his/her own control. Data at follow-up visits will be compared to the subjects' baseline data.
Study Objective:
The objective of this observational study is to assess the safety and effectiveness of the Spinal cord stimulation, in the treatment of Chronic Pelvic Pain at the study follow-up visits at 1, 3, 6, 9 and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pelvic pain
Key inclusion criteria (9 listed)
- 1. Have a clinical diagnosis of chronic predominant pelvic pain as determined by a multidisciplinary study team.
- 2. Score 13 or greater in PainDETECT questionnaire 3. 4. Have been refractory to conservative therapy for a minimum of 3 months, including assessment of at least 2 different classes of medications.
- 5. Average pain intensity (over the last 7 days) of ≥ 5 out 10 cm on the Visual Analog Scale (VAS) in the primary area of pain at enrollment (in accordance with the NICE guidelines).
- 6. Have stable neurological status measured by motor, sensory and reflex function as determined by the investigator.
- 7. Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion.
Key exclusion criteria (20 listed)
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator (such as primary headache diagnosis or fibromyalgia).
- Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury as determined by the investigator.
- Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator.
- Significant stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by MRI conducted within the past 12 months.
- Have a clinical diagnosis of unstable mental health condition or severe depression [request input on this exclusion criteria from the psychologist] including suicidal ideation.
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 |
|---|---|---|
| Spinal Cord Stimulation (SCS)Spinal Cord Stimulation (SCS) - High Frequency at 10 kHz | Procedure or surgery | – |
Primary outcome
Visual analog scale
Time frame: 1 month follow-up
Visual analog scale
Time frame: 3 month follow-up
Visual analog scale
Time frame: 6 month follow-up
Visual analog scale
Time frame: 9 month follow-up
Visual analog scale
Time frame: 12 month follow-up
Pain Disability Index
Time frame: 1 month follow-up
Pain Disability Index
Time frame: 3 month follow-up
Pain Disability Index
Time frame: 6 month follow-up
Pain Disability Index
Time frame: 9 month follow-up
Pain Disability Index
Time frame: 12 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Time frame: 1 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Time frame: 3 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Time frame: 6 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Time frame: 9 month follow-up
McGill Pain questionnaire (SF-MPQ-2)
Time frame: 12 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Time frame: 1 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Time frame: 3 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Time frame: 6 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Time frame: 9 month follow-up
European Quality of Life-5 Dimensions (EQ-5D-5L)
Time frame: 12 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Time frame: 1 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Time frame: 3 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Time frame: 6 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Time frame: 9 month follow-up
Short Form 12-Item Survey on Health (SF-12)
Time frame: 12 month follow-up
5 secondary outcomes
Neurologic status
Time frame: 6 month follow-up
Neurologic status
Time frame: 12 month follow-up
Hospitalizations
Time frame: 12 month follow-up
Adverse events
Time frame: 12 month follow-up
Medication usage
Time frame: 12 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
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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.
Nicolas Varela, MD, DESA contact
Róbert Rapcan, MD, PhD, MBA, FIPP study director
EPC Education s.r.o.
Ladislav Kočan, MD, PhD study chair
EPC Education s.r.o.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Pain, run by EPC Education s.r.o..
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 9 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashish Shetty, MD, FRCA, FFPMRCA (+447723309217, drashshetty@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 1 month follow-up). The study lists 25 primary outcomes in all. 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 13 May 2022.