Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)

Axonics

Status: Completed

Conditions: Overactive Bladder

Treatments: Device: Axonics Sacral Neuromodulation (SNM) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02620410

105-0010

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Axonics SNM System

Other group

Description:

Axonics SNM Therapy for urinary control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

Treatment:

Device: Axonics Sacral Neuromodulation (SNM) System