Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06978205

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Hui Wei

Jinan, Shandong, China, 250012

Actively Recruiting

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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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