Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury

NCT06978205 | Recruiting

• 1 other identifier: KYLL-202503-011-1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Residual urine volume

  Use a bladder capacity measuring instrument (model HD5, produced by Liaoning Hande Technology Co., Ltd.) to perform ultrasound testing on patients after urination and record residual urine volume.

  Before treatment and three consecutive days after treatment

• Voiding Diary

  Under the supervision of researchers and medical staff, patients were instructed to keep a urinary diary during hospitalization (including catheterization time, spontaneous displacement, catheterization volume, and catheterization frequency)

  Before treatment and three consecutive days after treatment

Secondary Outcomes (4)

• Short-Form Health Survey-Qualiveen (SF-Qualiveen)

  Before treatment and on the third day after treatment

• Neurogenic Bladder Symptom Score (NBSS)

  Before treatment and on the third day after treatment

• Core Lower Urinary Tract Symptom Rating Scale

  Before treatment and on the third day after treatment

• Hospital Anxiety and Depression Scale (HADS)

  Before treatment and on the third day after treatment

Study Arms (2)

conventional rehabilitation treatment.

ACTIVE COMPARATOR

Conventional rehabilitation treatment methods include intermittent catheterization, acupuncture and pelvic floor function training. Intermittent catheterization is based on the results of urodynamic examination to develop a personalized drinking plan and the number of catheterization, and the number of catheterization is selected according to the amount of residual urine. Acupuncture treatment improves the patient's urinary function by acupuncture on the lower abdomen and lumbosacral acupoints once a day, 5 days a week, for a total of 1-2 weeks. The pelvic floor therapist assesses the patient's pelvic floor muscle condition and guides the patient to perform effective pelvic floor muscle contractions and relaxations.

Device: intermittent catheterization; Device: Acupuncture treatment; Behavioral: Pelvic floor function training

Urethral Balloon Dilation

EXPERIMENTAL

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, 2-4 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. 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.

Device: Urethral Balloon Dilation; Device: intermittent catheterization; Device: Acupuncture treatment; Behavioral: Pelvic floor function training

Interventions

Urethral Balloon Dilation DEVICE

Urethral balloon dilation + conventional rehabilitation therapy. 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, 2-4 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. 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.

Urethral Balloon Dilation

intermittent catheterization DEVICE

Intermittent catheterization is based on the results of urodynamic examination to develop a personalized drinking plan and the number of catheterization, and the number of catheterization is selected according to the amount of residual urine.

Urethral Balloon Dilation; conventional rehabilitation treatment.

Acupuncture treatment DEVICE

Acupuncture treatment improves the patient's urinary function by acupuncture on the lower abdomen and lumbosacral acupoints.

Urethral Balloon Dilation; conventional rehabilitation treatment.

Pelvic floor function training BEHAVIORAL

The pelvic floor therapist assesses the patient's pelvic floor muscle condition and guides the patient to perform effective pelvic floor muscle contractions and relaxations.

Urethral Balloon Dilation; conventional rehabilitation treatment.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Urodynamic examination shows maximum urethral pressure greater than 50cmH2O
• No tumors or benign prostatic hyperplasia were found
• Patients who have had their indwelling urinary catheter removed
• Voluntary participation in research and signing of informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Hui Wei

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Urinary Retention

Interventions

Intermittent Urethral Catheterization; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Urinary Catheterization; Catheterization; Therapeutics; Investigative Techniques; Complementary Therapies

Central Study Contacts

Hui Wei

CONTACT

18560083563; 83926275@qq.com

Fuchao Yao

CONTACT

15168959521; yaofuchao2023@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 18, 2025
• Study Start: April 28, 2025
• Primary Completion: April 27, 2026
• Study Completion: May 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)