Posterior tibial nerve Vs Sham transcutaneous tibial nerve stimulation as neuromodulation therapy in treatment of detrusor overactivity in patients with spinal cord injury: A randomized control study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Reduction in number of leaks as observed by voiding diary
研究概览
简要总结
Previously two studies were conducted in regard to the neuromodulation of urinary bladder reflex pathway and our findings have been published as below. Both the studies have reported that the use of electrical stimulator on tibial nerve, dorsal penile and medial plantar nerve have reduced the episodes of urinary incontinence as measured by voiding diary in patients with spinal cord injury. Pre and Post Urodynamics studies on these participants have shown reduction in the detrusor overactivity. This study is RCT to study the effect of electrical stimulation in these group of participants on the posterior tibial nerve.
- Ojha R, George J, Chandy BR, Tharion G, Devasahayam SR. Neuromodulation by surface electrical stimulation of peripheral nerves for reduction of detrusor overactivity in patients with spinal cord injury: A pilot study. J Spinal Cord Med. 2015 Mar;38(2):207-13. doi: 10.1179/2045772313Y.0000000175. Epub 2014 Jan 3. PMID: 24621046; PMCID: PMC4397203.
2. Ojha R, Singh A, George J, Chandy BR. Neuromodulation of spinal reflex pathway for the treatment of detrusor overactivity by medial plantar nerve stimulation at surface of sole of foot in patients with spinal cord injury. J Neurosci Rural Pract. 2023 Jul-Sep;14(3):495-500. doi: 10.25259/JNRP_27_2023. Epub 2023 Aug 16. PMID: 37692814; PMCID: PMC10483192.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •age 18 years and above -Patient with spinal cord injury trojan having at least one leak per day(not stress leak) as reported in the voiding chart.
- •Clean intermittent catheterization -Presence of ankle jerk -CMG proven Detrusor overactivity.
排除标准
- •Urinary Tract Infection -Peripheral Neuropathy -Pregnant Women -Psychiatric ailment -Symptoms of stress incontinence -Presence of implantable devices such as cochlear implant, pace makers, metallic implantable plates.
结局指标
主要结局
1. Reduction in number of leaks as observed by voiding diary
时间窗: Outcome 1,2 and 3 are to be monitored one week prior to the start of the stimulation and during the period of stimulation i.e. for 3 weeks everyday.
2. Increase in fluid intake as observed by voiding diary
时间窗: Outcome 1,2 and 3 are to be monitored one week prior to the start of the stimulation and during the period of stimulation i.e. for 3 weeks everyday.
3. Improvement in bladder capacity as observed by the voiding diary
时间窗: Outcome 1,2 and 3 are to be monitored one week prior to the start of the stimulation and during the period of stimulation i.e. for 3 weeks everyday.
次要结局
- 1. Reduction of maximum detrusor pressure as observed through Cystometrogram (CMG)(2. Improvement in cystometric capacity as observed by CMG)
研究者
Dr Joy Darshan Gurindapalli
Department of Physical Medicine and Rehabilitation Christian Medical College