Clinical trial NCT06978205: Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
Official title: Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Urinary Bladder, Neurogenic
Urinary Retention
Keywords: Spinal Cord Injuries
neurogenic bladder
urinary retention
Urethral balloon dilation
zelen design
Randomized controlled clinical trial
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Standard Rehabilitation Treatment (Control Group)：Participants in the control group will receive conventional rehabilitation therapy: Pelvic floor muscle training and Biofeedback electrical stimulation.

Urethral Balloon Dilation (Intervention Group)：Participants in the intervention group will receive urethral balloon dilation in addition to standard rehabilitation therapy. The specific procedures are as follows:

1. A 14-Fr urethral catheter will be prefilled with sterile saline to check for balloon integrity. If intact, the saline will be completely withdrawn.
2. Ultrasound imaging will be used to precisely locate the external urethral sphincter.
3. The catheter will be fully lubricated and gently inserted into the urethra.
4. Under real-time ultrasound guidance, 2-3.5 mL of sterile saline will be gradually injected into the balloon to expand the external urethral sphincter.
5. Patients will be instructed to attempt urination during the procedure, and changes in voiding patterns will be observed.
6. After treatment, the balloon will be fully deflated, and the catheter will be carefully removed.

This procedure will be performed three times per participant. The expansion volume will increase by 0.5-1 mL per session, depending on urethral outlet resistance (urodynamic results) and degree of urethral narrowing (ultrasound assessment). Each session lasts 5 minutes. Strict aseptic techniques will be followed. The procedure will be conducted by experienced physicians under ultrasound guidance to ensure maximum safety and effectiveness.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-80 years old
2. 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
3. The spinal shock period has passed, and consciousness is clear with stable vital signs
4. 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
5. Urodynamic examination shows maximum urethral pressure greater than 50cmH2O
6. No tumors or benign prostatic hyperplasia were found
7. Patients who have had their indwelling urinary catheter removed
8. Voluntary participation in research and signing of informed consent form

Exclusion Criteria:

1. Patients with severe heart, brain, lung and other important organ diseases or mental and cognitive disorders
2. Individuals with disrupted water electrolyte and acid-base balance
3. There are serious kidney diseases, bladder fistula surgery, anterior urethral sphincterotomy and other diseases
4. There is a urinary system infection

Primary outcomes:
measure: Residual urine volume
timeFrame: Before treatment and three consecutive days after treatment
measure: Voiding Diary
timeFrame: Before treatment and three consecutive days after treatment
Secondary outcomes:
measure: Short-Form Health Survey-Qualiveen (SF-Qualiveen)
timeFrame: Before treatment and on the third day after treatment
measure: Neurogenic Bladder Symptom Score (NBSS)
timeFrame: Before treatment and on the third day after treatment
measure: Core Lower Urinary Tract Symptom Rating Scale
timeFrame: Before treatment and on the third day after treatment
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Before treatment and on the third day after treatment
Other outcomes:
Locations:
city: Jinan
country: China
facility: Hui Wei
state: Shandong
Study officials:
References: