High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Pelvic Pain Patients

Exclusion Criteria19

• Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
• 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 and fibromyalgia).
• Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist.
• Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, and/or central deafferentation syndrome.
• Have definable neuropathic processes, primary voiding dysfunction, active or recurrent urinary tract infections at a rate equal to or more than 3/year, and/or untreated pelvic pathology.
• Have a current diagnosis of a coagulation disorder, bleeding diathesis that would put patient at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease or uncontrolled diabetes mellitus.
• Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention.
• Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) that would disrupt/obliterate the posterior epidural space.
• Be benefitting from an interventional procedure and/or surgery to treat pelvic pain (Subjects should be enrolled at least 30 days from last benefit).
• Have had a pelvic laparoscopy procedure within the previous 6 months.
• Have an existing drug pump and/or another active implantable device (switched On or Off) such as a pacemaker or other SCS devices.
• Have a condition currently requiring or likely to require the use of MRI or diathermy.
• 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.
• Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
• Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs).
• Be involved in an injury claim under current litigation.
• Have a pending or approved worker’s compensation claim, and an ongoing planned litigation related to work