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Trial registered on ANZCTR


Registration number
ACTRN12614000989640
Ethics application status
Approved
Date submitted
14/08/2014
Date registered
15/09/2014
Date last updated
15/09/2014
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 285175 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-frequency spinal cord stimulation in patients with chronic, intractable pelvic pain. 292770 0
Condition category
Condition code
Reproductive Health and Childbirth 293061 293061 0 0
Other reproductive health and childbirth disorders
Musculoskeletal 293062 293062 0 0
Other muscular and skeletal disorders
Renal and Urogenital 293063 293063 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 290029 0
Not applicable
Comparator / control treatment
This is an observational study. No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292929 0
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)
Timepoint [1] 292929 0
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 [1] 309974 0
- Proportion of subjects who prefer sacral nerve root stimulation versus the proportion of subjects who prefer conus medullaris stimulation.
Timepoint [1] 309974 0
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.
Secondary outcome [2] 310071 0
- Trial success rates: all lead placements, sacral nerve root placement, conus medullaris placement as determined by pelvic pain visual analogue scale (VAS).
Timepoint [2] 310071 0
A Baseline assessment will be made prior to undergoing trial SCS implantation, followed by repeat assessments at completion of the trial.
Secondary outcome [3] 310072 0
Change from Baseline in sleep disturbance as measured by Pittsburgh Sleep Quality Index (PSQI).
Timepoint [3] 310072 0
3, 6 and 12 months post Baseline
Secondary outcome [4] 310173 0
Percentage change from Baseline in Pelvic Pain ('worst area', 'overall', and 'other' (if identified) as determined by visual analogue scale (VAS)
Timepoint [4] 310173 0
3, 6 and 12 months post Baseline
Secondary outcome [5] 310174 0
Change from Baseline in quality of life as measured by EQ-5D
Timepoint [5] 310174 0
3, 6 and 12 months post Baseline
Secondary outcome [6] 310175 0
Change from Baseline in Depression Anxiety Stress Scales (DASS-21) questionnaire.
Timepoint [6] 310175 0
3, 6 and 12 months post Baseline
Secondary outcome [7] 310176 0
Change from Baseline in opioid/narcotic medication usage as determined by patient daily diary preceding follow up visits.
Timepoint [7] 310176 0
3, 6 and 12 months post Baseline
Secondary outcome [8] 310177 0
Change from Baseline in Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) score
Timepoint [8] 310177 0
3, 6 and 12 months post Baseline
Secondary outcome [9] 310178 0
Change from Baseline in functioning as measured by Global Assessment of Functioning instrument (GAF)
Timepoint [9] 310178 0
3, 6 and 12 months post Baseline
Secondary outcome [10] 310179 0
Subject's impression of change in quality of life as measured by the Patient Global Impression of Change instrument (PGIC).
Timepoint [10] 310179 0
3, 6 and 12 months post Baseline
Secondary outcome [11] 310180 0
Investigator’s impression of change in subject quality of life as measured by the Clinician Global Impression of Change instrument (CGIC).
Timepoint [11] 310180 0
3, 6 and 12 months post Baseline
Secondary outcome [12] 310181 0
Subject's satisfaction with therapy as measured by a Subject Satisfaction Questionnaire (STSQ).
Timepoint [12] 310181 0
3, 6 and 12 months post Baseline
Secondary outcome [13] 310182 0
Change from Baseline in Over Active Bladder Symptom Score (OABSS) [as applicable]
Timepoint [13] 310182 0
3, 6 and 12 month post Baseline
Secondary outcome [14] 310184 0
Change from Baseline in Fecal Incontinence Symptom (FIS) score [as applicable]
Timepoint [14] 310184 0
3, 6 and 12 months post Baseline
Secondary outcome [15] 310185 0
Change from Baseline in Fecal Incontinence Quality of Life (FIQOL) score [as applicable]
Timepoint [15] 310185 0
3, 6 and 12 months post Baseline
Secondary outcome [16] 310186 0
Change from Baseline in Supplemental Pelvic Pain and Function Questionnaire
Timepoint [16] 310186 0
3, 6 and 12 months post Baseline
Secondary outcome [17] 310187 0
Assessment of program parameters and device usage, and their correlation to pain relief as determined by device interrogation data and visual analogue scale (VAS).
Timepoint [17] 310187 0
3, 6 and 12 months post Baseline
Secondary outcome [18] 310188 0
Change from Baseline in disability as measured by Pain Disability Index (PDI).
Timepoint [18] 310188 0
3, 6 and 12 months post Baseline
Secondary outcome [19] 310189 0
Change from Baseline in Short Form McGill Pain Questionnaire (SF-MPQ2).
Timepoint [19] 310189 0
3, 6 and 12 months post Baseline
Secondary outcome [20] 310190 0
Paresthesia generated by the Senza stimulator.
Timepoint [20] 310190 0
3, 6 and 12 months post Baseline

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289784 0
Commercial sector/Industry
Name [1] 289784 0
Nevro Corporation
Country [1] 289784 0
United States of America
Primary sponsor type
Individual
Name
Dr. Bruce Mitchell
Address
Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country
Australia
Secondary sponsor category [1] 288474 0
Individual
Name [1] 288474 0
Dr. Paul Verrills
Address [1] 288474 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country [1] 288474 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291521 0
Bellberry Ltd
Ethics committee address [1] 291521 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 291521 0
Australia
Date submitted for ethics approval [1] 291521 0
18/02/2014
Approval date [1] 291521 0
28/04/2014
Ethics approval number [1] 291521 0
2014-02-086

Summary
Brief summary
Chronic pelvic pain (CPP) is one of the most common medical problems among women, though it also affects men with a lower incidence . It is defined as pain in the pelvis that lasts more than six months and affects the patient’s quality of life. There are many potential sources of pelvic pain. Pelvic pain may involve the urinary, reproductive, gastrointestinal, neurological, psychological and musculoskeletal systems.

Patients with chronic pelvic pain typically receive multidisciplinary care, including medication (antimicrobials, anti-inflammatories, opioids, muscle relaxants, etc), psychotherapy, physical therapy, and interventional treatments (surgery for distension and ablative procedures). A significant proportion of these patients fail however to derive adequate benefits from these therapies and these CPP patients are often left with few options.
Traditional spinal cord stimulation (SCS) is a widely accepted cost-effective therapy for patients with chronic pain, especially in patients with post- surgery back and leg pain. SCS has been used successfully to treat intractable CPP patients.

A newer treatment, High-Frequency Spinal Cord Stimulation at 10 kHz (HF10TM SCS) using the Senza system (Nevro Corp, USA) has established itself as a key treatment in treating patients with chronic back pain: data from European and Australian pain centers has shown that HF10 SCS is safe and effective at reducing pain, improving function and sleep, and reducing opioid in patients with predominant back pain. The purpose of this study is to investigate the feasibility of using HF10-SCS to provide pain relief and quality of life improvements to CPP patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50722 0
Dr Bruce Mitchell
Address 50722 0
Metro Spinal Clinic Level 1 544 Hawthorn Road, Caulfield South Victoria 3162
Country 50722 0
Australia
Phone 50722 0
+61 3 9595 6111
Fax 50722 0
Email 50722 0
bmitchell@metrospinal.com.au
Contact person for public queries
Name 50723 0
Adele Barnard
Address 50723 0
Metro Spinal Clinic Level 1 544 Hawthorn Road, Caulfield South Victoria 3162
Country 50723 0
Australia
Phone 50723 0
+61 3 9595 6111
Fax 50723 0
Email 50723 0
abarnard@metrospinal.com.au
Contact person for scientific queries
Name 50724 0
Adele Barnard
Address 50724 0
Metro Spinal Clinic Level 1 544 Hawthorn Road, Caulfield South Victoria 3162
Country 50724 0
Australia
Phone 50724 0
+61 3 9595 6111
Fax 50724 0
Email 50724 0
abarnard@metrospinal.com.au

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No Supporting Document Provided



Results publications and other study-related documents

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