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Clinical Trial of Abdominal Breathing for Urinary Retention After Spinal Cord Injury

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06964256
Enrollment
60
Registered
2025-05-09
Start date
2024-05-06
Completion date
2025-06-02
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries (SCI), Urinary Retention

Brief summary

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.

Interventions

BEHAVIORALAbdominal breathing exercises

Control group: conventional rehabilitation treatment. 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 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 befor

OTHERControl group: intermittent catheterization

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

BEHAVIORALExperimental group: intermittent catheterization

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. 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

OTHERControl group and experimental group: acupuncture treatment

Acupuncture treatment uses acupuncture to act on the acupuncture points in the lower abdomen and lumbosacral region to improve the patient's urination function

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

(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. \-

Exclusion criteria

(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. \-

Design outcomes

Primary

MeasureTime frameDescription
Bladder residual urine output at 3 weeksThree weeksA 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.

Secondary

MeasureTime frameDescription
Glazer assessment valueThree weeksPelvic floor biostimulation feedback instrument Glazer evaluation was used to compare the resting state and contraction state of the two groups of patients at different stages of pelvic floor muscle electromyography
Short-form Health Survey-QualiveenThree weeksThe scale includes 4 dimensions and 8 items of annoyance (items 1\ 2), restriction (items 3\ 4), fear (items 5\ 6), and feeling (items 7\ 8). Each item was scored by Likert 5 grades, in which item 3 was assigned a score of never, rarely, sometimes, often and always, and the rest of the items were assigned 0\ 4 points according to none, a little, moderate, quite severe and extremely severe, the score of each dimension was the mean of each item within the dimension, and the score of the scale was the average score of each dimension, with a total score of 0\ 4 points, the lower the score, the better the quality of life of patients.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026