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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000989640
• Date of registration: 15/09/2014
• Prospective Registration: No
• Primary sponsor: Dr. Bruce Mitchell
• Public title: High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Pelvic Pain Patients
• Scientific title: A prospective, single-center, observational data collection study of high-frequency spinal cord stimulation at 10kHz (HF10 SCS) for the Treatment of Pelvic Pain Patients
• Date of first enrolment: 14/08/2014
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614000989640.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Adele Barnard

• Name: Dr Adele Barnard

Key inclusion & exclusion criteria

Inclusion criteria: - 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

Exclusion criteria: - 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


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Other muscular and skeletal disorders

High-frequency spinal cord stimulation in patients with chronic, intractable pelvic pain.;
High-frequency spinal cord stimulation in patients with chronic, intractable pelvic pain.

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Renal and Urogenital - Other renal and urogenital disorders

Intervention(s)

Twelve month observation of patients implanted with the Senza System for management of chronic, intractable pelvic pain via spinal cord stimulation (SCS).

SCS via the Senza System will be at a dose frequency of 10kHz. Duration will be up to 14 days during the trial period, followed by a 12 month oberservation period for those proceeding to a permanent implant.

The leads will be placed at sacral root and conus medullaris during the trial period. The permanent leads will be implanted at sacral root OR conus medullaris, based on the outcome of the trial period. The implantable pulse generator (IPG) is implanted as per standard of care/physician discretion (buttock, lateral flank/axillae etc). The duration of the implant procedure may be 20-40mins.

The device will be able to be controlled/turned on/off by the participant within the prescribed settings.

Primary Outcome(s)

The primary endpoint is the proportion of subjects who respond*(as assessed by visual analogue scale (VAS)) to Senza therapy for pelvic pain.
(*Responder is defined as a 30% or greater pain reduction from Baseline in their self-identified worst area of pain)
[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(s)

Change from Baseline in Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) score[3, 6 and 12 months post Baseline]

Change from Baseline in functioning as measured by Global Assessment of Functioning instrument (GAF)[3, 6 and 12 months post Baseline]

Change from Baseline in sleep disturbance as measured by Pittsburgh Sleep Quality Index (PSQI).

[3, 6 and 12 months post Baseline]

- Proportion of subjects who prefer sacral nerve root stimulation versus the proportion of subjects who prefer conus medullaris stimulation.
[A Baseline assessment will be made prior to undergoing trial SCS implantation. Following permanent implantation, assessments will be scheduled at 3, 6 and 12 months. ]

- Trial success rates: all lead placements, sacral nerve root placement, conus medullaris placement as determined by pelvic pain visual analogue scale (VAS).
[A Baseline assessment will be made prior to undergoing trial SCS implantation, followed by repeat assessments at completion of the trial.]

Change from Baseline in Fecal Incontinence Quality of Life (FIQOL) score [as applicable][3, 6 and 12 months post Baseline]

Percentage change from Baseline in Pelvic Pain ('worst area', 'overall', and 'other' (if identified) as determined by visual analogue scale (VAS)[3, 6 and 12 months post Baseline]

Subject's satisfaction with therapy as measured by a Subject Satisfaction Questionnaire (STSQ).[3, 6 and 12 months post Baseline]

Change from Baseline in Over Active Bladder Symptom Score (OABSS) [as applicable][3, 6 and 12 month post Baseline]

Change from Baseline in Short Form McGill Pain Questionnaire (SF-MPQ2).[3, 6 and 12 months post Baseline]

Paresthesia generated by the Senza stimulator.[3, 6 and 12 months post Baseline]

Change from Baseline in Depression Anxiety Stress Scales (DASS-21) questionnaire.[3, 6 and 12 months post Baseline]

Change from Baseline in quality of life as measured by EQ-5D[3, 6 and 12 months post Baseline]

Change from Baseline in disability as measured by Pain Disability Index (PDI).[3, 6 and 12 months post Baseline]

Assessment of program parameters and device usage, and their correlation to pain relief as determined by device interrogation data and visual analogue scale (VAS).[3, 6 and 12 months post Baseline]

Change from Baseline in Fecal Incontinence Symptom (FIS) score [as applicable][3, 6 and 12 months post Baseline]

Change from Baseline in opioid/narcotic medication usage as determined by patient daily diary preceding follow up visits.[3, 6 and 12 months post Baseline]

Change from Baseline in Supplemental Pelvic Pain and Function Questionnaire[3, 6 and 12 months post Baseline]

Subject's impression of change in quality of life as measured by the Patient Global Impression of Change instrument (PGIC).[3, 6 and 12 months post Baseline]

Investigator’s impression of change in subject quality of life as measured by the Clinician Global Impression of Change instrument (CGIC).[3, 6 and 12 months post Baseline]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Nevro Corporation

Secondary Sponsor(s)

Dr. Paul Verrills

Ethics review

Status: Approved
Approval date:
Contact:

Bellberry Ltd