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

NCT ID: NCT02620410

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2022-01-31

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Axonics SNM System

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.

Group Type: OTHER

Axonics Sacral Neuromodulation (SNM) System

Intervention Type: DEVICE

The implantable components of the Axonics Sacral Neuromodulation (SNM) System consist of an IPG and tined lead. Additional components include a clinician programmer, surgical tool kit, recharging kit, and patient remote control.

Interventions

Axonics Sacral Neuromodulation (SNM) System

The implantable components of the Axonics Sacral Neuromodulation (SNM) System consist of an IPG and tined lead. Additional components include a clinician programmer, surgical tool kit, recharging kit, and patient remote control.

Intervention Type: DEVICE

Other Intervention Names

Axonics SNM System

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sohier Elneil, MRCOG, PhD

Role: PRINCIPAL_INVESTIGATOR

University College London Hospital & National Hospital for Neurology & Neurosurgery

Locations

UZ Leuven

Leuven, , Belgium

Hospices Civils de Lyon

Lyon, , France

Chu De Nantes - Hôtel-Dieu

Nantes, , France

Maastricht University Medical Center

Maastricht, , Netherlands

Erasmus Medical Center

Rotterdam, , Netherlands

University College London Hospital

London, , United Kingdom

Countries

Belgium; France; Netherlands; United Kingdom

Other Identifiers

105-0010

Identifier Type: -

Identifier Source: org_study_id