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临床试验/NCT03472599
NCT03472599已完成不适用

Long Term Genital Nerve Stimulation to Improve Urinary Continence

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
4
主要终点
Incontinence

研究概览

简要总结

Bladder spasms after spinal cord injury (SCI) can result in incontinence, urinary tract infections, kidney damage, trigger dangerous increases in blood pressure and decrease independence and quality of life. The investigators' long-term goal is to develop and provide a "bladder pacemaker" able to restore bladder continence for Veterans with SCI. Electrical stimulation of sensory nerves can stop bladder spasms during a doctor visit. However, this approach has not been tested during long term home use. This proposal will 1) determine how well sensory stimulation reduces incontinence and improves quality of life for Veterans with SCI during 1 year of home use, and 2) produce an effective take home system that can be used by more Veterans and other VAs.

详细描述

The clinical problem of neurogenic detrusor overactivity (bladder hyper-reflexia) is among the most serious problems encountered by Veterans with neurologic injuries such as spinal cord injury (SCI). The majority of persons with SCI suffer from neurogenic bladder (73%) and only 17% of persons with traumatic SCI manage their bladders with voluntary micturition. The investigators' long-term goal is to develop and clinically implement a "bladder pacemaker" able to restore bladder continence for Veterans with spinal cord injury (SCI). This proposal will 1) determine the long-term effectiveness of genital nerve stimulation (GNS) to chronically ( 1 year) reduce urinary incontinence and improve quality of life for Veterans with SCI, and 2) develop and produce an effective take home GNS system that can be used by more Veterans, given to Veterans at the end of the study and used in future multi-VA studies.

The rationale for studying chronic GNS is based on the demonstration in humans with SCI that abnormal hyper-reflexive bladder contractions can be acutely inhibited and bladder capacity acutely increased using GNS. The peripheral and easily accessible location of the dorsal genital nerve (DGN) allows surface stimulation and therefore provides the potential for a less complicated surgical intervention than is currently available, increasing the number of individuals who could benefit from bladder control neural prostheses. While GNS has been demonstrated to be effective acutely by multiple groups, relatively few groups have attempted to test this approach for more than a day.

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

入选标准

  • Suprasacral neurogenic bladder following spinal cord injury, stroke, or multiple sclerosis
  • Neurologically stable
  • Skeletally mature, over 18 years of age.
  • Reflex bladder contractions confirmed by cystometrogram
  • At least six (6) months post spinal cord injury, stroke, or multiple sclerosis diagnosis
  • Able to understand and comply with study requirements
  • Able to understand and give informed consent

排除标准

  • Active sepsis
  • Open pressure sores on penis
  • Significant trauma, erosion or stricture of the urethra
  • Pregnancy
  • Individuals who do not speak English.

研究组 & 干预措施

Genital Nerve Stimulation

Experimental

Study participants in this arm will use take-home genital nerve stimulation for 24+ months in order to assess its effectiveness at decreasing urinary incontinence. In order to set effective genital nerve stimulation parameters, study participants will undergo clinical urodynamics every 6 months in which sensitivity to and tolerance of electrical stimulation are assessed.

干预措施: Genital Nerve Stimulation (Other)

结局指标

主要结局

Incontinence

时间窗: Collected over 24 months

The investigators will collect a record of leakage episodes (metric for incontinence) from the specified period.

Incontinence

时间窗: Collected over 1 month

Leakage episodes (metric for incontinence) collected over the initial month of testing.

Urgency

时间窗: Collected over 1 month

Urgency episodes collected over the initial month of testing.

次要结局

  • Bladder Capacity(Collected over 24 months)
  • Bladder Capacity(Collected over 1 month)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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