The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital
研究概览
简要总结
The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).
详细描述
In this study, TTNS will be used to help neurogenic bladder in SCI. First, acute SCI subjects which respond to TTNS will be identified as seen on urodynamic studies (USD). Then, responders will be invited to participate in a randomized control trial of a 2-week protocol of TTNS to test for safety and efficacy during inpatient rehabilitation to evaluate bladder changes based upon pre- and post- urodynamic testing, as well as 2-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment within 6 weeks of injury
- •Neurologic level rostral to T10 (T9 and above). This is a significant neurologic level because the bladder remains innervated at these levels, without damage to the nerve cell bodies of the bladder within the spinal cord.
- •Location and transportation available for follow-up appointments
排除标准
- •History of peripheral neuropathy or premorbid symptoms of peripheral neuropathy
- •Known etiologies that may cause peripheral neuropathy (i.e. diabetes mellitus, hypothyroidism, autoimmune diseases, alcoholism, hx of chemotherapy, etc.)
- •History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
- •Pregnancy
- •History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
- •Morbid obesity
- •Ventilator dependent respiration
- •Significant autonomic dysreflexia during baseline urodynamic study.
结局指标
主要结局
Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital
时间窗: about 4 weeks
Number of Participants With Skin Irritation
时间窗: about 4 weeks
Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.
Number of Participants With Infection
时间窗: about 4 weeks
All infections were urinary tract infections (UTIs).
Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)
时间窗: baseline, about 30 minutes
Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject's "mean change in pain score": \[Average of the post-stimulation measurements for all 10 time points\] minus \[Average of baseline measurements for all 10 time points time point\] = \[mean change in pain score\]. The value reported is the mean of all participants' "mean change in pain score." The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain.
次要结局
- Maximum Detrusor Pressure as Evaluated by Urodynamic Study(2 weeks)
- Maximum Bladder Capacity as Evaluated by Urodynamic Study(2 weeks)
研究者
Argyrios Stampas, MD
Assistant Professor
The University of Texas Health Science Center, Houston