A Prospective, Single Arm, Interventional, Self-controlled Pilot Study to Assess the Performance and Safety of the New Generation, Wireless, Implantable Tibial Nerve Stimulator System (eCoin™) for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change from baseline in bladder volume (mL)
研究概览
简要总结
Prevalence of lower urinary tract symptoms (LUTS) in patients with MS increases with disease duration. Current management of urinary clinical symptoms in MS is mainly conservative. Its long-term outcome is often poor because of the progressive disease course and the treatment related side effects. Alternative therapeutic options are botulinum toxin injections, electrical stimulation of dorsal penile/clitoral nerve, and sacral nerve modulation. Posterior tibial nerve stimulation (PTNS) is a second minimally-invasive method of electrical stimulation. Multiple benefits may derive from the development and validation of a dedicated protocol of a new self-activated neuromodulation therapy, which may improve therapy compliance/effectiveness, quality of life and social life in MS patients with refractory LUTS. Furthermore, it may contribute to reduce outpatient visits, health costs and work absenteeism.
To investigate the performance and safety of the medical device eCoin™ for the treatment of refractory LUTS in patients with MS over a period of 6 months.
详细描述
This is a prospective, interventional, single arm, self-controlled pilot study in patients with multiple sclerosis and OAB symptoms with a 6-month treatment period of posterior tibial nerve stimulation with the medical device eCoin.
It is a pilot study to explore the effectiveness and safety of using this device to treat MS patients with OAB in daily clinical practice in. Based on feasibility considerations, we plan to include approximately 20 patients.
It consists of:
- wash-out period from PTNS treatment of at least 2 months;
- baseline assessments;
- implantation of eCoin;
- system activation; and
- treatment and follow-up visits for a 6-month period post implant activation. Seven Visits are foreseen during the trial.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Diagnosis of MS according to MacDonald (2011);
- •Clinical stability over the past 6 months (no relapses or EDSS progression over the last 6 months);
- •One or more of: urinary frequency greater than 8 times/24 hours, urinary urge incontinence at least 2 episodes in 24 hours on 3-day voiding diary
- •Urodynamic diagnosis of detrusor over-activity (DOA) and / or detrusor-sphincter dyssynergia (DSD);
- •Previous failure of conservative treatments (challenge over ≥6 months) i.e. lifestyle modification-fluid consumption, behavioural modification, and pharmacological therapy and stable OAB medications for at least 30 days or intolerance to pharmacological therapy (side effect);
- •Positive response to ongoing PTNS treatment defined as ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency [<8 voids/day], based on retrospective diary review;
- •Competent sphincter mechanism and normally functioning upper urinary tract;
- •Leg circumference in the range of 20-30 cm at implantation site;
- •Ability to comply with study requirements;
- •Having provided written informed consent
排除标准
- •Participation in another study with any investigational drug or device within the past 90 days;
- •Any metal implant in the area of eCoin implantation site;
- •Anatomical defects that preclude use of the device;
- •Treatment with botulinum toxin injections, urinary incontinence surgery or implantation of artificial graft material, spinal or genitourinary surgery, abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male) within the last 6 months;
- •Previous treatment with sacral neuromodulation;
- •Diagnosis of pelvic pain disorders, stress incontinence, current urinary tract infection, urinary stone and/or urinary tract malignancy; cystocele, enterocele or rectocele of grade 3 or 4;
- •Previous or current pelvic radiotherapy and/or chemotherapy;
- •Severe uncontrolled diabetes;
- •Pregnant or lactating women or women planning a pregnancy
结局指标
主要结局
Change from baseline in bladder volume (mL)
时间窗: Baseline and Week 24
The patients will have their bladder filling volume measured during a urodynamic exam.
Change from baseline of detrusor pressure amplitude (cmH2O)
时间窗: Baseline and Week 24
The patients will have their detrusor pressure measured during an urodynamic exam.
次要结局
- Change from baseline of bladder compliance (mL/cmH2O)(Baseline and Week 24)
- Change from baseline of maximum detrusor pressure (cmH20) during voiding phase(Baseline and Week 24)
- Change from baseline of maximum detrusor pressure (cmH20) during storage phase(Baseline and Week 24)
- Change from baseline of maximum urine flow rate (mL/s)(Baseline and Week 24)
- Change from baseline of post void residual urine (mL)(Baseline and Week 24)
- Change from baseline to 4, 12, and 24 weeks of bladder voiding assessed by means of a 3-day voiding diary(Baseline and Week 4, 12, 24)
- Change from baseline to 4, 12, and 24 weeks of overactive bladder symptoms scores using the short form of the overactive bladder questionnaire OAB-q(Baseline, Week 4, 12, 24)
- Treatment satisfaction, as measured on a composite visual analogue scale (VAS) score ranging from 0-100(Week 24)
- Change from baseline of cystometric capacity (mL)(Baseline and Week 24)
- Change from baseline of vesico-uretero-renal reflux(Baseline and Week 24)
- Change from baseline of voided urine volume (mL)(Baseline and Week 24)
- Change from baseline of pelvic floor electromyographic activity(Baseline and Week 24)
- Change from baseline to 4, 12, and 24 weeks of MSQOL54 scores.(Week -8, 4, 12, 24)
- Incidence of adverse events(Week 0, 5, 12, 24)
研究者
Chiara Zecca
Principal Investigator
Ente Ospedaliero Cantonale, Bellinzona