High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Pelvic Pain Patients
- Conditions
- High-frequency spinal cord stimulation in patients with chronic, intractable pelvic pain.Reproductive Health and Childbirth - Other reproductive health and childbirth disordersMusculoskeletal - Other muscular and skeletal disordersRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12614000989640
- Lead Sponsor
- Dr. Bruce Mitchell
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Have been diagnosed with chronic, intractable pelvic pain, with diagnoses including (but not limited to) painful bladder syndrome, prostadynia, vulvodynia, interstitial cystitis, coccydynia, epididymitis, urogenital pain, perineal pain, pudendal neuralgia, obturator neuralgia, perianal pain, pelvic girdle pain, endometriosis, and colorectal pain.
- Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted Senza device
- Be 18 years of age or over
- Considering daily activity and rest, have average ‘worst area’ of pelvic pain intensity of equal to or greater than 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
- Undergoing treatment for chronic intractable pelvic pain
- Has made the decision to undergo treatment for their chronic pelvic pain with Senza therapy Willing and able to complete protocol requirements including:
- Willing and able to complete health questionnaires and pain scales as specified in the protocol
- Willing and able to sign the study-specific Informed Consent form
- 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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the proportion of subjects who respond*(as assessed by visual analogue scale (VAS)) to Senza therapy for pelvic pain.<br>(*Responder is defined as a 30% or greater pain reduction from Baseline in their self-identified worst area of pain)<br>[A baseline assessment will be made prior to undergoing trial spinal cord stimulation (SCS) implantation. Following permanent implantation, follow up assessments will be scheduled at 3, 6 and 12 months. The primary endpoint assessments will take place at the 6 month timepoint.]
- Secondary Outcome Measures
Name Time Method