The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Maximum Cystometric Capacity
研究概览
简要总结
The purpose of this study is to see what effects sacral neuromodulation has on bladder function and quality of life in patients with acute spinal cord injury. Within 12-weeks of injury, participants will either receive an implanted nerve stimulator (like a pace-maker for the bladder) or standard care for neurogenic bladder. Patients will be assigned to one of these groups at random and followed for one year. The hypothesis is that early stimulation of the nerves will help prevent the development of neurogenic bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Age > 18 years
- •Ability to implant device less than 12 weeks post-spinal cord injury (SCI)
- •Presence of acute SCI at or above T12
- •American Spinal Injury Association (ASIA) Scale A or B
- •Expectation to perform clean intermittent catheterization (CIC) personally or have caretaker perform CIC
排除标准
- •Inability to perform CIC
- •Pre-existing SCI
- •Pre-existing progressive neurological disorder
- •Autonomic dysreflexia
- •Prior sacral back surgery
- •Posterior pelvic fracture with distortion of the sacroiliac joint
- •Prior urethral sphincter or bladder dysfunction
- •Chronic urinary tract infections prior to SCI
- •Pregnancy at the time of enrollment
- •Presence of coagulation disorder or need for anticoagulation that they cannot be stopped temporarily for procedure
- •Any significant co-morbidity or illness that would preclude their participation or increase the risk to them having a surgical procedure
- •Active untreated infection
- •Traumatic injury to the genitourinary system
- •Prior pelvic radiation, bladder cancer or other surgical procedure to the bladder that would effect baseline bladder physiology
研究组 & 干预措施
Sacral neuromodulation
Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.
干预措施: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) (Device)
Standard care
Patients will receive standard neurogenic bladder care.
结局指标
主要结局
Maximum Cystometric Capacity
时间窗: 12 months
Maximum bladder capacity as measured by urodynamic study at 12 months
Quality of Life Differences Measured by Mean SCI-QoL
时间窗: 12 months
Participant-reported quality of life as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) bladder question banks at 12 months. Scores range from 64-320 with a lower score indicating greater satisfaction with quality of life.
Number of Urinary Tract Infections Requiring Antibiotics
时间窗: from enrollment through the end of follow-up at 12 months
次要结局
- Maximum Cystometric Capacity at 3 Months(3 months)
- Bladder Compliance(3, 12 months)
- Presence of Detrusor Overactivity(3, 12 months)
- Volume at First Detrusor Contraction(3, 12 months)
- Pressure at First Detrusor Contraction(3, 12 months)
- Daily Number of Catheterizations(3, 6, 9, 12 months)
- Average Catheterization Volume(3, 6, 9, 12 months)
- Urinary Incontinence Episodes Per Day(3, 6, 9, 12 months)
- 24 Hour Pad Weight Test(3, 6, 9, 12 months)
- Development of Hydronephrosis(12 months)
- Need for Anticholinergic Medication(from enrollment through the end of follow-up at 12 months)
- Need for Onabotulinum Toxin A Injection(from enrollment through the end of follow-up at 12 months)
- Need for Device Revision(from implant through the end of follow-up at 12 months)
- Device Explanation(from implant through the end of follow-up at 12 months)
- Hospitalizations(from enrollment through the end of follow-up at 12 months)
- Urologic Related Surgeries(from enrollment through the end of follow-up at 12 months)
- Death(from enrollment through the end of follow-up at 12 months)
研究者
Jeremy Myers
Associate Professor of Surgery
University of Utah