NCT04567264已完成不适用
Prospective Single Centre Trial of Percutaneous Tibial Nerve Stimulation With the Implantable StimRouter Neuromodulation System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
Chiara Zecca2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年8月26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
- 23
- 试验地点
- 2
- 主要终点
- Change in bladder volume
研究概览
简要总结
Prevalence of lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (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.
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
- •Male or female aged 18 - 80;
- •Diagnosis of multiple sclerosis according to McDonald [20];
- •Clinical stability over the past 6 months (no relapses and no disability progression, defined as worsening of ≥1 point in the EDSS score if reference EDSS is ≤5.5, and ≥0.5 points if reference EDSS is>5.5);
- •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, behavioral modification, and pharmacological therapy and stable OAB medications for at least 30 days;
- •No pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists) for 2 weeks prior to screening;
- •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 (treatment compliant and non-compliant patients) or PTNS treatment naïve able to sense tibial nerve stimulation (to be tested with TENS exam).
- •Competent sphincter mechanism and normally functioning upper urinary tract;
- •Leg circumference in the range of 20-30 cm at implantation site;
- •No contraindications for surgical intervention (e.g. being immunocompetent, no anticoagulant treatment, no current infection);
- •For female patients: using effective contraceptive methods;
- •Ability to comply with study requirements;
- •Having provided written informed consent.
排除标准
- •Previous participation in another study with any investigational drug or device within the past 90 days;
- •Any metal implant in the area of StimRouter lead 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;
- •Critical limb ischemia;
- •Previous or current pelvic radiotherapy and/or chemotherapy;
- •Severe uncontrolled diabetes;
- •Being prone to excessive bleeding;
- •Having a pacemaker or implantable defibrillator or other neural stimulation systems;
- •Exposure to diathermy or electrocautery;
- •Clinically significant peripheral neuropathy;
- •Neutropenic or immune compromised;
- •Pelvic radio- and/or chemotherapy;
- •Morbid obesity (BMI >40);
- •Pregnant or lactating women, or women planning a pregnancy during the study, <9 months post-partum;
- •Male: alpha-blocker for benign prostatic hyperplasia;
- •Allergy to local anesthetic or adhesive;
- •Life expectancy <1 year.
结局指标
主要结局
Change in bladder volume
时间窗: 6 months
filling volume at the time of the first uninhibited detrusor contraction during cystometry
次要结局
- Degree of urgency prior to void(3, 4.5, 6 months)
- Number of CISC through the day(3, 4.5, 6 months)
- Residual urine volume(3, 4.5, 6 months)
- Number of leaks per day(3, 4.5, 6 months)
- Compliance (ml/cmH20)(6 months)
- Voided volume (mL)(6 months)
- Maximum flow rate (mL/s)(6 months)
- Pelvic floor electromyographic activity (normal/detrusor sphincter dyssynergia/non-relaxing pelvic floor)(6 months)
- Number of voids/day(3, 4.5, 6 months)
- Volume voided/void(3, 4.5, 6 months)
- Maximum detrusor pressure (cmH20) during storage phase(6 months)
- Maximum detrusor pressure (cmH20) during voiding phase(6 months)
- Post void residual(6 months)
- Cystometric capacity (mL)(6 months)
- Multiple Sclerosis Quality of Life-54 (MSQOL-54)(3, 4.5, 6 months)
- Over active bladder questionnaire (OAB)(3, 4.5, 6 months)
研究者
Chiara Zecca
Principal Investigator, Deputy Head of Multiple Sclerosis Center
Ente Ospedaliero Cantonale, Bellinzona
研究点 (2)
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