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Completed

NCT Number: NCT06964256

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

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.

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

107 Wenhua Xi Road, Ji'nan Shandong 250012

Jinan, jinan, 250012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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.

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Treatment and study plan

Abdominal breathing exercises

Behavioral

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

Control group: intermittent catheterization

Other

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

Other names: Control group: Acupuncture treatment

Experimental group: intermittent catheterization

Behavioral

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

Other names: Experimental group: acupuncture treatment, Experimental group: abdominal breathing training

Control group and experimental group: acupuncture treatment

Other

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

Primary outcomes

  1. Bladder residual urine output at 3 weeks

    Time frame: 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.

Secondary outcomes

  1. Glazer assessment value

    Time frame: Three weeks

    Pelvic 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

  2. Short-form Health Survey-Qualiveen

    Time frame: Three weeks

    The 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.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 9, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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