NCT05241379已完成不适用
Exploratory Safety and Electrophysiological Study of Closed-loop Pudendal Neuromodulation Using an Implantable (Picostim-DyNeuMo) Device in Women With Urinary Incontinence
Amber Therapeutics Ltd2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Adverse Device Events
研究概览
简要总结
AMBER AURA-2 study (Augmenting Urinary Reflex Activity 2) is a short-duration (6 month) safety and electrophysiological study using an implanted Amber UI system and two electrode leads to provide closed-loop pudendal nerve stimulation for the treatment of urinary incontinence.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥ 18 years
- •Diagnosis of urinary incontinence, with on a 5-day voiding diary at least 1 daily urgency episode and/or greater than or equal to 8 voids/day and/or by having a minimum of two involuntary leaking episodes in 72 hr
- •Duration of urinary incontinence symptom ≥ 6 months prior to the screening baseline visit date
- •Failed or is not a candidate for more conservative treatment e.g. pelvic floor muscle therapy or biofeedback or behavioral modification
- •Failed or could not tolerate at least one (1) antimuscarinic or beta3-adrenoceptor agonist medication
- •Urodynamic testing (uroflowmetry, cystometry and pressure flow) completed within 12 months prior to screening baseline visit date or is willing to have testing at screening baseline visit
- •Cystoscopy test completed within 12 months prior to the screening baseline visit date or is willing to have a test at screening baseline visit
- •Is willing and able to washout from OAB medications for at least 4 week prior to beginning the baseline voiding diary
- •Ability and willingness to give informed consent including language constraints (see above)
- •Able to participate in all testing and follow-up clinic visits associated with study protocol
- •Capable of independently using the system components (after training) as described in the Patient Manual
- •Mobile and able to use toilet without assistance
排除标准
- •Patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study (pregnancy tests provided in schedule)
- •Patient is unwilling or unable to use contraception during sexual intercourse for the duration of the study, and thereafter if implant remains in the longer term.
- •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
- •Any neurological condition that may interfere with normal bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease; clinically significant peripheral neuropathy, or complete spinal cord injury)
- •Patient has uncontrolled type I or type II diabetes as defined by their routine care clinician or diabetes with peripheral nerve involvement
- •Any history of any pelvic cancer
- •Patient has history of other non-pelvic neoplasia within 5 years prior to enrolment, except for a cancer that was determined to be local occurrence only, such as basal cell carcinoma, or is receiving or planning to receive anti-cancer or anti-angiogenic drugs
- •Patient has proven major autoimmune disease, e.g. scleroderma or immunodeficiency (including use of biologic immunomodulatory drugs at time of procedure)
- •Life expectancy of less than 1 year
- •Patient is a frail elderly and/or with notable clinical evidence of sarcopaenia
- •Patient is not suitable for the study as determined by their routine care physician for any other reason
- •Patient is enrolled in another interventional study excepting observational studies, e.g. SNM registries or in relation to disease (see below)
- •Patient participation in vigorous sporting activities where these cannot be restricted for a period of 6 weeks post-implantation.
- •Specific urological
- •Urinary tract mechanical obstruction such as urethral stricture
- •Current symptomatic urinary tract infection (UTI) or more than 3 UTIs in past year
- •Pure stress incontinence or mixed incontinence where the stress component overrides the urge component
- •Interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines
- •Suspected pudendal nerve entrapment syndrome. In patients with co-existent symptoms of chronic pelvic pain and urinary incontinence, Nantes criteria will be used for screening. Patients meeting essential criteria will be excluded from the study
- •Treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
- •Prior attempt at pudendal nerve stimulation using an implanted lead
- •Treatment of urinary symptoms with tibial or sacral nerve stimulation in the past 3 months (prior experience of either before this time is permitted provided no implants remain in-situ)
- •Specific technical
- •Patient is significantly obese (defined as BMI ≥ 35) so as to limit electrode lead placement using standard approaches
- •Skin, orthopaedic or neurological anatomical limitations that could prevent successful placement of the electrode lead
- •Knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
- •Implantable neurostimulator, pacemaker or defibrillator in situ (anywhere in body including sacral and tibial)
- •Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
结局指标
主要结局
Adverse Device Events
时间窗: 24 hours; 1 week; 4 weeks; 3 months; 6 months
Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1
次要结局
- Changes in Voiding diary data(Baseline, 28 days, 3 months, 6 months)
- Changes in ICIQ -UI Short Form(Baseline, 28 days, 3 months, 6 months)
- Changes in ICIQ-OAB Quality of Life(Baseline, 28 days, 3 months, 6 months)
- Technical Outcomes(24 hours postoperatively)
- Changes in FSFI(Baseline, 28 days, 3 months, 6 months)
- Measurement of EMG(During procedure, 24 hours and 6 months)
- Changes in PGI-I(Baseline, 28 days, 3 months, 6 months)
研究者
研究点 (2)
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