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

Overactive Bladder Clinical Trial

— RELAX-OAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620410
• Other study ID #: 105-0010
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2022

Study information

• Verified date: August 2022
• Source: Axonics Modulation Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2022
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
France	Hospices Civils de Lyon	Lyon
France	Chu De Nantes - Hôtel-Dieu	Nantes
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Medical Center	Rotterdam
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Axonics Modulation Technologies, Inc.

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of serious adverse device effects (SADEs)		3 Months, 1 Year, 2 Year post-implantation
Secondary	Rate of adverse device effects (ADEs)		3 Months, 1 Year, 2 Year post-implantation
Secondary	Rate of adverse procedure effects (APEs)		3 Months, 1 Year, 2 Year post-implantation
Secondary	Rate of serious adverse events (SAEs)		3 Months, 1 Year, 2 Year post-implantation
Secondary	Rate of adverse events (AEs)		3 Months, 1 Year, 2 Year post-implantation
Secondary	Device performance metrics	Data recorded from the patient's devices (Device Readings)	3 Months, 1 Year, 2 Year post-implantation
Secondary	Average leaks per day (3-day voiding diary)		3 Months, 1 Year, 2 Year post-implantation
Secondary	Average voids per day (3-day voiding diary)		3 Months, 1 Year, 2 Year post-implantation
Secondary	Percent of subjects with successful treatment	Defined as either 1) a 50% improvement in the number of average leaks or the number of voids per day or 2) a return to a normal number of voids per day (<8 voids)	3 Months, 1 Year, 2 Year post-implantation
Secondary	SF-12	General quality of life questionnaire	3 Months, 1 Year, 2 Year post-implantation
Secondary	EQ-5D	Questionnaire assessing general quality of life	3 Months, 1 Year, 2 Year post-implantation
Secondary	ICIQ-UI Short Form	Quality of life questionnaire assessing urinary incontinence	3 Months, 1 Year, 2 Year post-implantation
Secondary	ICIQ-OABqol	Quality of life questionnaire assessing over active bladder	3 Months, 1 Year, 2 Year post-implantation
Secondary	I-QOL	Quality of life questionnaire assessing urinary incontinence	3 Months, 1 Year, 2 Year post-implantation
Secondary	Patient satisfaction with treatment	Questionnaire in scale format assessing treatment-specific satisfaction	3 Months, 1 Year, 2 Year post-implantation
Secondary	Healthcare utilization	Questionnaire about subject's medical treatment	3 Months, 1 Year, 2 Year post-implantation