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临床试验/NCT06964256
NCT06964256已完成不适用

Evaluation of the Efficacy and Safety of sEMG Monitoring of Lower Abdominal Breathing Training in the Treatment of Urinary Retention After Spinal Cord Injury: a Randomized Controlled Trial

Qilu Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Bladder residual urine output at 3 weeks

研究概览

简要总结

Randomized controlled trials were conducted in patients with urinary retention after spinal cord injury. The effects of abdominal breathing training on pelvic floor muscle tone, muscle strength and residual urine volume in patients with urinary retention after spinal cord injury were observed by Glazer and bladder volume measurement to compare the electromyography value and residual urine volume of pelvic floor muscles at different stages of resting state and contraction state of the two groups, and the subjective feelings of the patients were evaluated in combination with relevant scales. To provide a scientific basis for abdominal breathing as an adjuvant treatment for urinary retention after spinal cord injury.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •(1) Meet the "International Standards for the Neurological Classification of Spinal Cord Injuries" formulated by the American Spinal Cord Injury Association, and after the end of the spinal cord shock period, the ASIA classification is B, C, and D, and the clinical manifestations are urinary retention, residual urine > 100ml, and gender is not limited; (2) Age 16-80 years old; (3) The course of the disease is within 12 months; (4) Intermittent catheterization; (5) Pelvic floor muscle function test shows pelvic floor muscle hypotonia; (6) Have good communication skills, voluntarily participate in the trial and sign the informed consent form.

排除标准

  • •(1) Patients with severe urinary tract infection and hydronephrosis; (2) Those with other serious diseases; (3) Respiratory failure or tracheostomy; (4) patients with urinary retention not caused by spinal cord injury; (5) Dermato-electrode passers; (6) Patients with consciousness impairment and cognitive impairment; (7) Patients with poor treatment compliance and inability to follow doctor's instructions.

研究组 & 干预措施

Control group: conventional rehabilitation treatment.

Active Comparator

Conventional rehabilitation treatment methods include intermittent catheterization and acupuncture. Intermittent catheterization is based on the results of urodynamic examination to develop a personalized drinking plan and the number of catheterization, and the number of catheterization is selected according to the amount of residual urine; Intermittent catheterization can reduce the rate of urinary tract infections, the incidence of urethral stones, and improve bladder capacity. Acupuncture treatment improves the patient's urinary function by acupuncture on the lower abdomen and lumbosacral acupoints once a day, 5 days a week, for a total of 3 weeks

干预措施: Control group: intermittent catheterization (Other)

Control group: conventional rehabilitation treatment.

Active Comparator

Conventional rehabilitation treatment methods include intermittent catheterization and acupuncture. Intermittent catheterization is based on the results of urodynamic examination to develop a personalized drinking plan and the number of catheterization, and the number of catheterization is selected according to the amount of residual urine; Intermittent catheterization can reduce the rate of urinary tract infections, the incidence of urethral stones, and improve bladder capacity. Acupuncture treatment improves the patient's urinary function by acupuncture on the lower abdomen and lumbosacral acupoints once a day, 5 days a week, for a total of 3 weeks

干预措施: Control group and experimental group: acupuncture treatment (Other)

Experimental group: Conventional rehabilitation treatment sEMG monitoring of lower abdominal breathi

Experimental

Experimental group: Conventional rehabilitation treatment sEMG monitoring of lower abdominal breathing training.

The conventional rehabilitation treatment method is the same as above; The specific operation of sEMG abdominal breathing training: ask the patient to empty the bladder before training, the patient to take a supine position, hip and knee flexion 60 degrees (for those who cannot maintain hip and knee flexion in the lower limbs, family members can assist), at the same time, the electrodes are attached to both sides of the patient's anus, the reference electrode is attached to the anterior superior iliac spine, the biostimulation feedback instrument is used to collect the patient's pelvic floor muscle electromyography value, and the patient is instructed to breathe in the abdomen, slowly inhale through the nose when inhaling, and put the hand on the abdomen to feel the abdomen slowly bulge for 3-5s; Exhale slowly with your mouth and slowly tighten your abdomen for 3-5s; For p

干预措施: Control group and experimental group: acupuncture treatment (Other)

Experimental group: Conventional rehabilitation treatment sEMG monitoring of lower abdominal breathi

Experimental

Experimental group: Conventional rehabilitation treatment sEMG monitoring of lower abdominal breathing training.

The conventional rehabilitation treatment method is the same as above; The specific operation of sEMG abdominal breathing training: ask the patient to empty the bladder before training, the patient to take a supine position, hip and knee flexion 60 degrees (for those who cannot maintain hip and knee flexion in the lower limbs, family members can assist), at the same time, the electrodes are attached to both sides of the patient's anus, the reference electrode is attached to the anterior superior iliac spine, the biostimulation feedback instrument is used to collect the patient's pelvic floor muscle electromyography value, and the patient is instructed to breathe in the abdomen, slowly inhale through the nose when inhaling, and put the hand on the abdomen to feel the abdomen slowly bulge for 3-5s; Exhale slowly with your mouth and slowly tighten your abdomen for 3-5s; For p

干预措施: Abdominal breathing exercises (Behavioral)

Experimental group: Conventional rehabilitation treatment sEMG monitoring of lower abdominal breathi

Experimental

Experimental group: Conventional rehabilitation treatment sEMG monitoring of lower abdominal breathing training.

The conventional rehabilitation treatment method is the same as above; The specific operation of sEMG abdominal breathing training: ask the patient to empty the bladder before training, the patient to take a supine position, hip and knee flexion 60 degrees (for those who cannot maintain hip and knee flexion in the lower limbs, family members can assist), at the same time, the electrodes are attached to both sides of the patient's anus, the reference electrode is attached to the anterior superior iliac spine, the biostimulation feedback instrument is used to collect the patient's pelvic floor muscle electromyography value, and the patient is instructed to breathe in the abdomen, slowly inhale through the nose when inhaling, and put the hand on the abdomen to feel the abdomen slowly bulge for 3-5s; Exhale slowly with your mouth and slowly tighten your abdomen for 3-5s; For p

干预措施: Experimental group: intermittent catheterization (Behavioral)

结局指标

主要结局

Bladder residual urine output at 3 weeks

时间窗: Three weeks

A bladder volume measuring instrument (model HD5, produced by Liaoning Hande Technology Co., Ltd.) was used to perform ultrasound detection and record the residual urine volume after urination.

次要结局

  • Glazer assessment value(Three weeks)
  • Short-form Health Survey-Qualiveen(Three weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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