Actively Recruiting
Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
Led by Qilu Hospital of Shandong University · Updated on 2025-05-18
74
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Trial Objectives: This clinical trial aims to explore whether ultrasound - guided urethral balloon dilation can effectively improve the micturition function of patients with urinary retention after spinal cord injury, and to evaluate the safety of this treatment method. The main questions it attempts to answer are: Can ultrasound - guided urethral balloon dilation reduce the residual urine volume and improve the quality of life of patients with urinary retention after spinal cord injury? Trial Design: Researchers will compare the group receiving ultrasound - guided urethral balloon dilation combined with conventional rehabilitation therapy (the experimental group) with the group receiving only conventional rehabilitation therapy (the control group) to determine the therapeutic effect of ultrasound - guided urethral balloon dilation on urinary retention after spinal cord injury. Tasks for Participants: Participants in the experimental group will receive ultrasound - guided urethral balloon dilation and cooperate with conventional rehabilitation therapy (including acupuncture therapy, pelvic floor biofeedback electrical stimulation, and pelvic floor function training). Participants in the control group will receive only conventional rehabilitation therapy for a period of 1 - 2 weeks. During the intervention, patients are required to strictly record a micturition diary under the guidance of researchers or medical staff. The diary should cover details such as daily spontaneous urine output, daily catheterized urine output, daily urine leakage volume, and daily frequency of catheterization. Residual urine volume will be detected every day for three days before the intervention and three days after the intervention.
CONDITIONS
Official Title
Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Confirmed spinal cord injury diagnosis by CT or MRI imaging
- Spinal shock period has passed with clear consciousness and stable vital signs
- Diagnosed with urinary retention after spinal cord injury with bladder residual urine volume over 300 ml
- Urodynamic examination showing maximum urethral pressure greater than 50 cmH2O
- No tumors or benign prostatic hyperplasia present
- Indwelling urinary catheter has been removed
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Severe heart, brain, lung, or other major organ diseases or mental and cognitive disorders
- Disruption of water electrolyte and acid-base balance
- Serious kidney diseases, bladder fistula surgery, anterior urethral sphincterotomy, or similar conditions
- Presence of urinary system infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hui Wei
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
H
Hui Wei
CONTACT
F
Fuchao Yao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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