Clinical trial NCT02620410: Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)
Official title: Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: OAB
Lead sponsor: Axonics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment of the symptoms of overactive bladder (OAB) as well as capturing patient satisfaction and quality of life data.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of OAB as demonstrated on a 3-day voiding diary defined as ≥ 8 voids/day, and/or a minimum of 2 involuntary leaking episodes in a 72-hour period
* Positive motor response on at least two implanted electrodes during intraoperative test
* Failed, or are not a candidate for more conservative treatment (e.g., pelvic floor training, biofeedback, behavioral modification, oral pharmacotherapy)
* No changes to current regimen of medications that affect bladder function for at least 4 weeks prior to beginning the baseline voiding diary
* Willing and capable of providing informed consent
* Capable of participating in all testing associated with this clinical investigation

Exclusion Criteria:

* Primary stress incontinence or mixed incontinence where the stress component overrides the urgency component
* Current urinary tract mechanical obstruction such as benign prostatic enlargement or urethral stricture
* Interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines
* History of any pelvic cancer
* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
* Any psychiatric or personality disorder at the discretion of the study physician
* PHQ-9 Patient Depression Score ≥ 10
* Current symptomatic urinary tract infection (UTI) or more than 3 UTIs in past year
* Any neurological condition that may interfere with normal bladder function, including stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
* Severe or uncontrolled diabetes (A1C \> 8, documented in the last 3 months) or diabetes with peripheral nerve involvement
* Treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
* Treatment of urinary symptoms with tibial nerve stimulation in the past 3 months
* Previously implanted with a sacral neuromodulation device or participated in a sacral neuromodulation trial
* Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
* Knowledge of planned MRIs, diathermy, or high output ultrasonic exposure
* Any other active implanted devices including neurostimulators (e.g., cochlear implant, pacemaker) and/or drug delivery pumps, whether turned on or off
* Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site
* A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
* Participation in a current clinical trial or within the preceding 30 days

Primary outcomes:
measure: Mean change in ICIQ-OABqol HRQL Total Score compared to baseline.
timeFrame: 3 Months
Secondary outcomes:
measure: Rate of serious adverse device effects (SADEs)
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Rate of adverse device effects (ADEs)
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Rate of adverse procedure effects (APEs)
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Rate of serious adverse events (SAEs)
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Rate of adverse events (AEs)
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Device performance metrics
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Average leaks per day (3-day voiding diary)
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Average voids per day (3-day voiding diary)
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Percent of subjects with successful treatment
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: SF-12
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: EQ-5D
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: ICIQ-UI Short Form
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: ICIQ-OABqol
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: I-QOL
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Patient satisfaction with treatment
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
measure: Healthcare utilization
timeFrame: 3 Months, 1 Year, 2 Year post-implantation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nantes
country: France
facility: Chu De Nantes - Hôtel-Dieu
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: University College London Hospital & National Hospital for Neurology & Neurosurgery
name: Sohier Elneil, MRCOG, PhD
role: PRINCIPAL_INVESTIGATOR
References: