Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Bladder capacity
研究概览
简要总结
This study aims to improve continence and voiding of patients with spinal cord injury using electrical stimulation.
The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving bladder and bowel function in patients with spinal cord injury (SCI). It has been commercially available in Britain and other countries since 1982, and has been used in thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing urination on demand and to aid in bowel evacuation.
Electrical stimulation to produce bladder contraction and improve bladder voiding after spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex contraction of the bladder, which improves continence. However, cutting these nerves has undesirable side effects. This study will not cut any sensory nerve. This study is testing the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to improve continence after spinal cord injury, and for blocking sphincter contraction to improve voiding.
详细描述
Human subjects will be recruited from people with clinically complete spinal cord injury.
Subjects who meet the selection criteria described below will be screened to identify those whose reflex bladder contractions are inhibited by neuromodulation using low levels of electrical stimulation via electrodes on the skin over the dorsal genital nerve. Serial filling cystometries will be performed in the clinical urodynamic laboratories at the study sites. Bladder capacity and compliance will be recorded for each cytometrogram. Subjects whose reflex bladder contractions are significantly inhibited by this neuromodulation will be offered enrollment in the trial. Subjects whose reflex bladder contractions are not significantly inhibited by this neuromodulation, or who do not wish to participate in the study, will be able to continue with their usual form of bladder management.
After screening, selected subjects will be offered surgical implantation of a Vocare Bladder System in the FDA-approved manner, but without posterior rhizotomy. Because posterior rhizotomy is not performed, the afferent axons in the sacral nerves are intact and can be stimulated after surgery via the electrodes connected to the implanted stimulator.
The Vocare Bladder System will be implanted in the FDA-approved manner but without posterior rhizotomy.
After implantation, subjects will be evaluated in the urodynamic laboratory. Stimulation will applied to S34 sacral nerves bilaterally, and the effects on bladder capacity and continence and voiding will be measured.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be included if they meet all of the following criteria:
- •Complete spinal cord injury (AIS grade A) of at least 2 years duration with neurological level (ISNCSCI level) below C4
- •Impaired bladder emptying due to Detrusor External Sphincter Dyssynergia-DESD (unco-ordinated contraction of bladder and external urethral sphincter) as shown on video-urodynamic testing.
- •Impaired continence due to detrusor hyper-reflexia
排除标准
- •Subjects will be excluded if they meet any of the following criteria:
- •Absence of reflex contractions of the bladder as shown on urodynamic testing
- •Absence of reflex contractions of the external urethral sphincter as shown on urodynamic testing with EMG
- •External sphincterotomy, urethral stricture or previous urethral or sphincter or bladder or prostate surgery
- •History of pelvic fracture
- •Subjects on anticoagulants or with coagulation disorders
- •Immunosuppressed subjects
- •Active or recurrent pressure ulcers, particularly in sacral, ischial or trochanteric areas
- •Active untreated infection
- •Active implanted medical device such as cardiac pacemaker or defibrillator
- •Progressive spinal cord injury
- •Pregnancy
- •Mechanical ventilator dependency
- •Any other significant co-morbidity or illness that would preclude their participation or increase the risk to them of participating in the study
- •Inability or unwillingness to follow study protocol or give informed consent
研究组 & 干预措施
Finetech Vocare Bladder System
This is a pilot study of the Finetech Vocare Bladder System to improve continence and voiding in human subjects with chronic spinal cord injury. Each subject will act as their own control, comparing function with the Finetech Vocare Bladder System in use and not in use.
干预措施: Finetech Vocare Bladder System (Device)
结局指标
主要结局
Bladder capacity
时间窗: Change from baseline bladder capacity at 12-month follow-up visit
Bladder capacity (ml.) measured during filling cystometry
次要结局
- Frequency of incontinence of urine(Change from baseline frequency of incontinence of urine at 12-month follow-up visit)
研究者
Graham Creasey
Professor
Palo Alto Veterans Institute for Research