Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-01 @ 2:58 AM
Study NCT ID:
NCT06978205
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
Sponsor:
Qilu Hospital of Shandong University
Organization:
Study Overview
Official Title:
Effect of Urethral Balloon Dilatation on Urinary Retention After Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: