Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System: RELAX-OAB

Completed

• Conditions: OAB; overactive bladder; 10004994

• Registration Number: NL-OMON47196
• Lead Sponsor: Axonics Modulation Technologies, Inc.

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-01-10
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- Diagnosis of OAB as demonstrated on a 3-day voiding diary defined as * 8 voids/day, and/or a minimum of two involuntary leaking episodes in a 72-hour period
- Positive motor response on at least two implanted electrodes during intraoperative test
- 18 years of age or older
- 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 and completing the baseline voiding diary and baseline questionnaires
- 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 (e.g. Crohn*s disease, moderate to severe fibromyalgia, etc.)
- 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 on areas other than the head, 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Effectiveness Endpoint: Mean change in ICIQ-OABqol HRQL Total Score at<br /><br>3 months compared to baseline<br /><br><br /><br>Safety Measures:<br /><br>-Serious adverse device effects (SADEs)<br /><br>-Adverse device effects (ADEs)<br /><br>-Adverse procedure effects (APEs)<br /><br>-Serious adverse events (SAEs)<br /><br>-Adverse events (AEs)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Performance Measures:<br /><br>-Device performance metrics<br /><br>-Average leaks per day (3-day voiding diary)<br /><br>-Average voids per day (3-day voiding diary)<br /><br>-Percent of subjects with successful treatment, defined as either 1) a 50%<br /><br>improvement in the number of average leaks or the number of voids per day or 2)<br /><br>a return to a normal number of voids per day (<8 voids)<br /><br>-Quality of life questionnaires (SF-12, EQ-5D, ICIQ-UI Short Form, ICIQ-OABqol,<br /><br>I-QOL)<br /><br>-Patient satisfaction with treatment<br /><br>-Medication usage<br /><br>-Healthcare utilization</p><br>