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临床试验/NCT00378664
NCT00378664已完成2 期

Lumbar to Sacral Ventral Nerve Re-Routing

Kenneth Peters, MD0 个研究点目标入组 13 人开始时间: 2006年9月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
13
主要终点
Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients.

研究概览

简要总结

To assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in Spinal Cord Injury and spina bifida patients

详细描述

Spinal cord injury (SCI) and spina bifida is a source of irreversible injury to the spinal cord often resulting in paralysis and loss of sensation below the waist. The inability to urinate normally is a consequence of both conditions (neurogenic voiding dysfunction). In spina bifida and spinal cord injury, the nerve that controls the bladder and sphincter (the muscle that squeezes the bladder neck to prevent leaking) may no longer work properly resulting in patients who cannot urinate or are constantly wet.

Most patients will maintain high pressures in their bladder and these elevated pressures will eventually take its toll by causing recurrent urinary tract infections, backup of urine to the kidneys, and marked dilatation of possible further damage to the kidneys. Many patients eventually suffer from irreversible renal (kidney) damage, where dialysis or kidney transplant is the only way to sustain life.

Spinal bifida (present at birth) and SCI (occurs most often early in the fourth decade of life) predominately affect young individuals and longevity and quality of life may be greatly reduced by the presence of bladder, bowel, and sexual dysfunction. In the recent past, medications and catheters were the only way to help cord injured patients empty their bladders. Although clean intermittent catheterization (CIC) provides good maintenance results, medications can help conserve low bladder pressures, and antibiotics sustain an infection free urinary tract, these are difficult bladder management programs to uphold. They are expensive, time consuming, and outcomes are inconsistent.

A new surgical procedure has potential for treatment of spinal cord injuries/ spinal bifida. Recently, Dr. Chuan-Guo Xiao from China developed a surgical procedure of rewiring the nerves in the spinal cord to gain better control of urination and avoid complications of neurogenic bladder. The procedure reconnects live wires (nerves) to dead wires.

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
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female paraplegics 18 years and older with spinal cord lesion above L1 on a CIC program for bladder management and a score of "A" on ASIA scale.
  • Male and female patients age 6 and older with myelomeningocele spina bifida (surgically closed at birth) on a CIC program for bladder management.
  • Neurogenic bladder documented by urodynamic testing.
  • Stable neurogenic bladder dysfunction of at least 1 year or more.
  • Compliant bladder wall.
  • Normal renal function.

排除标准

  • History of bladder cancer, augmentation, or radiation.
  • Bladder capacity less than 100 milliliters (ml).
  • Anatomic outlet obstruction or urethral strictures.
  • Vesico-ureteric reflux grade 2 or higher.
  • Presence of an ileal conduit or supra-pubic catheter drainage.
  • Contraindications to general anesthesia or surgery.
  • Inability to complete follow up visits for 3 years.
  • Inability to comprehend and answer self-administered questionnaires.

研究组 & 干预措施

Intervention

Experimental

All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.

干预措施: lumbar to sacral ventral nerve re-routing procedure (Procedure)

结局指标

主要结局

Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients.

时间窗: evaluated at 6 months and 1 year

次要结局

  • Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients(evaluate at 6 month and 1 year)
  • Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients(evaluated at 6 month and 1 year visit)
  • Assess the effect of the lumbar to sacral ventral nerve re-routing on ability to perform activities of daily living in SCI and spina bifida patients(evaluate at 6 month and 1 year visit)
  • Assess the effect of the lumbar to sacral ventral nerve re-routing on sexual function in SCI patients 18 years of age and older(evaluate at 6 months and 1 year)

研究者

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

Kenneth Peters, MD

Principal Investigator

William Beaumont Hospitals

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