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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether ultrasound-guided urethral balloon dilation can improve bladder emptying function and reduce residual urine in patients with urinary retention after spinal cord injury. The study compares this procedure combined with conventional rehabilitation therapy against rehabilitation therapy alone to assess its safety and impact on quality of life. The trial focuses on adults with spinal cord injury-related urinary retention confirmed by imaging and clinical criteria. Participants in the experimental group will receive ultrasound-guided urethral balloon dilation three times, where a catheter balloon is gradually expanded under ultrasound to relax the urethral sphincter, combined with standard rehabilitation therapies like acupuncture, pelvic floor electrical stimulation, and muscle training. The control group will receive only conventional rehabilitation therapy, including intermittent catheterization and pelvic floor exercises, for 1 to 2 weeks. Treatment sessions last about 5 minutes each with close monitoring. Throughout the study, participants will keep a detailed urinary diary recording urine output, leakage, and catheterization frequency. Residual urine volume will be measured daily for 3 days before and after treatment. Researchers will assess bladder function, quality of life, urinary symptoms, and mood using validated questionnaires before and shortly after the intervention. Safety and clinical outcomes will be tracked during the trial period ending in May 2026.
CONDITIONS
Brief 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 according to ASIA 2013 criteria
- Spinal shock period 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 exam showing maximum urethral pressure over 50 cmH2O
- No tumors or benign prostatic hyperplasia detected
- Indwelling urinary catheter has been removed
- Voluntary participation with signed informed consent
You will not qualify if you...
- Severe heart, brain, lung or other major organ diseases, or mental and cognitive disorders
- Disrupted water electrolyte and acid-base balance
- Serious kidney diseases, bladder fistula surgery, anterior urethral sphincterotomy or similar conditions
- Current urinary system infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 weeks
Participants in the intervention group undergo urethral balloon dilation under ultrasound guidance three times to expand the external urethral sphincter, in addition to standard rehabilitation therapy. Participants in the control group receive conventional rehabilitation therapy including intermittent catheterization, acupuncture treatment, and pelvic floor function training.
3 urethral balloon dilation sessions and daily acupuncture treatments 5 days a week
Duration - 3 days
Participants are observed for changes in urinary function and complete various assessments including residual urine volume, voiding diary, and symptom rating scales before treatment and on the third day after treatment.
Assessments conducted before treatment and for three consecutive days after treatment
Trial Site Locations
Total: 1 location
1
Hui Wei
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
H
Hui Wei
F
Fuchao Yao
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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