Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
Qualifiers
Age between 18-80 years old
There is a confirmed diagnosis report of CT or MRI imaging, with the first diagnosis being spinal cord injury (complete or incomplete), which conforms to the International Classification of Spinal Cord Injury Neurology published by the American Spinal Injury Association (ASIA) in 2013
The spinal shock period has passed, and consciousness is clear with stable vital signs
In line with the diagnostic criteria of urinary retention and in combination with clinical practice: the patient can urinate autonomously before spinal cord injury, which is confirmed as spinal cord injury by clinical examination. It is manifested as retention of urine after spinal cord injury, swelling of lower abdomen, filling of bladder, dullness on percussion, residual urine volume of bladder B ultrasonic examination is more than 300ml, which shows that urination is laborious
Disqualifiers
Patients with severe heart, brain, lung and other important organ diseases or mental and cognitive disorders
Individuals with disrupted water electrolyte and acid-base balance
There are serious kidney diseases, bladder fistula surgery, anterior urethral sphincterotomy and other diseases
There is a urinary system infection
Trial design
Treatments tested in this trial
- Urethral Balloon Dilation
- intermittent catheterization
- Acupuncture treatment
- Pelvic floor function training
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov