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临床试验/NCT05740527
NCT05740527已完成不适用

Ambulatory Closed-loop Stimulation to Inhibit Neurogenic Bladder Over-activity

MetroHealth Medical Center2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
successful reduction of neurogenic bladder spasms

研究概览

简要总结

Individuals with spinal cord injury (SCI) develop neurogenic detrusor overactivity (NDO), resulting in urinary incontinence, decreased bladder capacity, and reduced quality of life. Current treatments incompletely address the problem and have unwanted side effects. Therefore, an alternative approach is needed. Electrical stimulation of the genital nerves (GNS) can inhibit NDO, improving bladder capacity and urinary continence. However, an automated closed-loop bladder feedback system, which currently does not exist, is necessary for individuals with SCI and NDO to utilize this therapy. The researchers have developed a custom algorithm to detect bladder contractions in real time, which requires only a bladder pressure signal. Our collaborators have developed a wireless, catheter-free bladder pressure sensor, called the UroMonitor, that was recently approved for testing in human participants. The goal of this project is to evaluate the potential feasibility and effectiveness of automated closed-loop GNS to inhibit unwanted bladder contractions using our custom algorithm and the wireless UroMonitor sensor. This project represents the next logical step toward improving or restoring bladder control using existing or emerging approaches to meet an important need for individuals with SCI. Successful completion of this project will motivate advancing a closed-loop approach using our custom algorithm and wireless bladder pressure sensor.

详细描述

This study has three study visits: a consenting visit (~1 hour), a screening visit (~4 hours), and an ambulatory visit (~8 hours).

Visit 1: The participant will have the study explained to their satisfaction and sign the consent form, if the participant chooses to participate. A urine sample is collected to test for urinary tract infections and a prophylactic antibiotic is prescribed.

Note: The participant is asked to refrain from taking medications related to bladder relaxation (Ditropan, Oxybutynin, Detrol, Tolterodine Tartate, Tofranil, Imipramine, Urimax, Xanodine, Enablex, Darifenain) as these will interfere with the study. When to stop these medications will be discussed with the participant at this visit.

Visit 2: The participant will have a urodynamic screening visit to confirm NDO activity, determine the response to stimulation, and determine the most effective stimulation parameters for genital nerve stimulation.

  • Urodynamics involves a catheter being inserted into the bladder to collect pressure readings from the bladder, and urethral sphincter, as well as infuse saline (salt water) into the bladder. This will be done up to 6 times, with and without stimulation, over the course of the 4 hour screening visit.
  • During urodynamics a catheter is also inserted into the rectum. This sensor detects abdominal pressure during urodynamics and is used to determine the pressure in the bladder.

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 SCI (above L5/S1 level of the spinal cord)
  • Neurologically stable
  • Mature skeleton
  • At least 6 months post-injury
  • Neurogenic detrusor overactity (NDO) confirmed by urodynamic study

排除标准

  • Active sepsis
  • Open pressure ulcers on or around the pelvis (electrode sites)
  • Significant trauma, erosion, or stricture of the urethra
  • History of autonomic dysreflexia

结局指标

主要结局

successful reduction of neurogenic bladder spasms

时间窗: within 2 weeks of completing the screening visit

The closed-loop system has been designed to detect neurogenic bladder spasms (contractions) and to turn on a device to deliver genital nerve stimulation. Genital nerve stimulation has been shown previously to relax NDO bladder spasms and therefore allow for increased capacity, longer time between catheterization, and a reduction in incontinence episodes. The outcome for this feasibility trial will be the ability of the system to perform within expected parameters (\<5% false negative, \<10% false positive, \<5 s response time) to control NDO bladder contractions.

次要结局

  • Comparison of bladder activity with and without genital nerve stimulation(within 1 week of signing consent form)
  • Documentation of NDO with cystometrogram (urodynamics)(within 1 week of signing consent form)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis Bourbeau

Principal Investigator

MetroHealth Medical Center

研究点 (2)

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