Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 6
- 主要终点
- Mean change in ICIQ-OABqol HRQL Total Score compared to baseline.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean change in ICIQ-OABqol HRQL Total Score compared to baseline.
时间窗: 3 Months
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.
次要结局
- Healthcare utilization(3 Months, 1 Year, 2 Year post-implantation)
- Rate of adverse procedure effects (APEs)(3 Months, 1 Year, 2 Year post-implantation)
- Device performance metrics(3 Months, 1 Year, 2 Year post-implantation)
- Average leaks per day (3-day voiding diary)(3 Months, 1 Year, 2 Year post-implantation)
- EQ-5D(3 Months, 1 Year, 2 Year post-implantation)
- ICIQ-UI Short Form(3 Months, 1 Year, 2 Year post-implantation)
- Patient satisfaction with treatment(3 Months, 1 Year, 2 Year post-implantation)
- Rate of adverse device effects (ADEs)(3 Months, 1 Year, 2 Year post-implantation)
- SF-12(3 Months, 1 Year, 2 Year post-implantation)
- Rate of serious adverse events (SAEs)(3 Months, 1 Year, 2 Year post-implantation)
- Rate of serious adverse device effects (SADEs)(3 Months, 1 Year, 2 Year post-implantation)
- Rate of adverse events (AEs)(3 Months, 1 Year, 2 Year post-implantation)
- ICIQ-OABqol(3 Months, 1 Year, 2 Year post-implantation)
- I-QOL(3 Months, 1 Year, 2 Year post-implantation)
- Average voids per day (3-day voiding diary)(3 Months, 1 Year, 2 Year post-implantation)
- Percent of subjects with successful treatment(3 Months, 1 Year, 2 Year post-implantation)