Effect of Magnetic Therapy in Bladder Dysfunction and Quality of Life in Paraplegic Patients

Cairo University1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2023年11月5日最近更新: 2024年3月5日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Cairo University
入组人数: 40
试验地点: 1
主要终点: Qualiveen short version 8 questions from 1 to 4 (worse if high score)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Each study subject will undergo baseline urodynamic testing (UDS) at the beginning of the study to confirm the diagnosis of a neurogenic bladder with DSD and establish baseline bladder functions. The study will be divided into two phases: a Treatment phase (16 weeks) and a Follow-up phase (6 weeks). During the treatment phase, each subject will undergo once/week magnetic spinal cord stimulation (MSCS) at 1Hz (low) frequency (40-60% intensity) over the lumbar spine. Once each subject entered the treatment phase of the study and will receive weekly lumbar spinal cord magnetic stimulation for a total of 16 weeks. This 16-week period of MSCS constituted bladder rehabilitation. Each subject will receive non-video urodynamic testing once every four weeks during the treatment phase to monitor progress and ensure that bladder function will not further impaired. After the initial four-week stimulation period, each subject will be asked to attempt volitional urination for 5-10minutes prior to bladder catheterization. the subjects will instruct to keep the environment quiet, relax and focus on voiding

详细描述

Forty male Paraplegic patients will be recruited.…from outpatients' clinics and their ages from 20 to 35 years and the inclusion criteria for the study will be a stable American Spinal Injury Association Impairment Scale (AISA) A/B, motor complete spinal cord injury between spinal levels T6-T12 present for greater than 1 year, and a documented history of neurogenic bladder requiring intermittent catheterization. Each subject will require to have at least three prior urodynamic studies to confirm the diagnosis of neurogenic bladder with detrusor sphincter dyssynergia (DSD), which was diagnosed with urodynamic study in which a rise in detrusor pressure and concomitant needle EMG activity and rise in urethral pressure were demonstrated Patients with a history of autonomic dysreflexia were excluded from the study. Any patient who will be ventilator dependent, abusing drugs, have musculoskeletal dysfunction (i.e., unstable fractures), cardiopulmonary diseases, active infections or ongoing depression requiring treatment, or have previous exposure to and use of spinal cord stimulation will be excluded from the study. Patients with a history of bladder Botox injection or bladder/sphincter surgeries will be excluded

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: Double (Participant, Outcomes Assessor)

盲法说明

double blinded

入排标准

年龄范围: 20 Years 至 35 Years（Adult）
性别: Male
接受健康志愿者: 否

入选标准

•IInclusion Criteria:
•Male Participants ages 20 to 35 years
•Participants will be a stable American Spinal Injury Association Impairment Scale (AISA) A/B.
•Motor incomplete spinal cord injury between spinal levels T6-T
•Participants present for more than 1 year.
•Each participant will require at least three prior urodynamic studies to confirm the diagnosis of neurogenic bladder with detrusor sphincter dyssynergia (DSD), which was diagnosed with urodynamic study.

排除标准

•Patients with a history of autonomic dysreflexia.
•Any patient who will be ventilator dependent, abusing drugs, have musculoskeletal dysfunction (i.e., unstable fractures).
•Any patient who will have cardiopulmonary diseases, active infections or ongoing depression requiring treatment, or have previous exposure to and use of spinal cord stimulation.
•Patients with a history of bladder Botox injection or bladder/sphincter surgeries.

研究组 & 干预措施

Magnetic therapy group

Experimental

receive magnetic therapy plus pelvic floor exercises.

干预措施: magnetic therapy (Device)

Pelvic floor exercises group

No Intervention

pelvic floor exercises only