NCT06964256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

April 17, 2025

Last Update Submit

July 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bladder residual urine output at 3 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.

    Three weeks

Secondary Outcomes (2)

  • Glazer assessment value

    Three weeks

  • Short-form Health Survey-Qualiveen

    Three weeks

Study Arms (2)

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

Other: Control group: intermittent catheterizationOther: Control group and experimental group: acupuncture treatment

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

Behavioral: Abdominal breathing exercisesBehavioral: Experimental group: intermittent catheterizationOther: Control group and experimental group: acupuncture treatment

Interventions

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

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

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

Also known as: Control group: Acupuncture treatment
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. 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

Also known as: Experimental group: acupuncture treatment, Experimental group: abdominal breathing training
Experimental group: Conventional rehabilitation treatment sEMG monitoring of lower abdominal breathi

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

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

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

107 Wenhua Xi Road, Ji'nan Shandong 250012

Jinan, jinan, 250012, China

Location

MeSH Terms

Conditions

Spinal Cord InjuriesUrinary Retention

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

May 9, 2025

Study Start

May 6, 2024

Primary Completion

April 27, 2025

Study Completion

June 2, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations