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

NCT02620410 | Completed DMC

• 1 other identifier: 105-0010
• Study Type: interventional
• Target: 51
• Locations: 4 countries
• Sites: 6

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

Keywords

OAB

Outcome Measures

Primary Outcomes (1)

• Mean change in ICIQ-OABqol HRQL Total Score compared to baseline.

  A disease-specific quality of life questionnaire. The ICIQ-OABqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in patients with overactive bladder for use in research and clinical practice across the world. The ICIQ-OABqol is the OAB-q adapted for use within the ICIQ structure and provides a detailed and robust measure to assess the impact of overactive bladder on quality of life. It is an ideal research tool as it explores in detail the impact on patients' lives of overactive bladder. The Third International Consultation on Incontinence recommended that all randomised trials evaluating treatments for incontinence use high quality questionnaires, in particular the ICIQ, to assess impact on patient outcome and facilitate comparisons. The ICIQ-OABqol provides a robust measure for this purpose.

  3 Months

Secondary Outcomes (16)

• Rate of serious adverse device effects (SADEs)

  3 Months, 1 Year, 2 Year post-implantation

• Rate of adverse device effects (ADEs)

  3 Months, 1 Year, 2 Year post-implantation

• Rate of adverse procedure effects (APEs)

  3 Months, 1 Year, 2 Year post-implantation

• Rate of serious adverse events (SAEs)

  3 Months, 1 Year, 2 Year post-implantation

• Rate of adverse events (AEs)

  3 Months, 1 Year, 2 Year post-implantation

Study Arms (1)

Axonics SNM System

OTHER

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.

Device: Axonics Sacral Neuromodulation (SNM) System

Interventions

Axonics Sacral Neuromodulation (SNM) System 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.

Also known as: Axonics SNM System

Axonics SNM System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Axonics, Inc.: lead

Study Sites (6)

UZ Leuven

Leuven, Belgium

Location

Hospices Civils de Lyon

Lyon, France

Location

Chu De Nantes - Hôtel-Dieu

Nantes, France

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

University College London Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Sohier Elneil, MRCOG, PhD

  University College London Hospital & National Hospital for Neurology & Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: January 1, 2022
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

GB (1); FR (2); NL (2); BE (1)