Volume 27, Issue 1 (5-2026)
Arch Rehabil 2026, 27(1): 174-197 |
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Yao F, Lu X, Zha Y, Li J, Wei H. Effectiveness of Ultrasound-guided Urethral Balloon Dilation for Urinary Retention Following Spinal Cord Injury: Protocol for a Zelen Design Randomized Controlled Trial. Arch Rehabil 2026; 27 (1) :174-197
URL: http://rehabilitationj.uswr.ac.ir/article-1-3687-en.html
URL: http://rehabilitationj.uswr.ac.ir/article-1-3687-en.html
1- School of Nursing and Rehabilitation, Shandong University, Jinan, China. & Rehabilitation Center, Qilu Hospital, Shandong University, Jinan, China.
2- School of Nursing and Rehabilitation, Shandong University, Jinan, China.
3- Rehabilitation Center, Qilu Hospital, Shandong University, Jinan, China. ,kkkk-9806@163.com, 83926275@qq.com
2- School of Nursing and Rehabilitation, Shandong University, Jinan, China.
3- Rehabilitation Center, Qilu Hospital, Shandong University, Jinan, China. ,
Abstract: (1026 Views)
Objective The primary aim of this study is to evaluate the effectiveness of ultrasound-guided urethral balloon dilation (UBD) in improving voiding function in patients with spinal cord injury (SCI)-related urinary retention, and the key secondary aims are to assess the impact of UBD on psychological status and health-related quality of life.
Materials & Methods A randomized controlled trial based on the Zelen design will be conducted. A total of 74 patients with SCI-related urinary retention will be recruited and randomized into a conventional rehabilitation group or a UBD treatment group. Primary outcomes include post-void residual (PVR) urine volume, voiding diary data, and urodynamic parameters. Secondary outcomes include quality of life (SF-Qualiveen), bladder symptom scores (neurogenic bladder symptom score [NBSS], core lower urinary tract symptom score [CLSS]), psychological status (the hospital anxiety and depression scale [HADS]), and ultrasonographic assessments of urethral structure and mobility (e.g. external urethral sphincter thickness, urethral width, sphincter volume, and urethral mobility).
Results This is a protocol paper; results are not yet available and will be reported in the primary publication.
Conclusion This protocol aims to evaluate whether ultrasound-guided UBD is a feasible and clinically useful option for managing urinary retention after SCI. The findings will provide preliminary evidence to inform its future clinical application.
Materials & Methods A randomized controlled trial based on the Zelen design will be conducted. A total of 74 patients with SCI-related urinary retention will be recruited and randomized into a conventional rehabilitation group or a UBD treatment group. Primary outcomes include post-void residual (PVR) urine volume, voiding diary data, and urodynamic parameters. Secondary outcomes include quality of life (SF-Qualiveen), bladder symptom scores (neurogenic bladder symptom score [NBSS], core lower urinary tract symptom score [CLSS]), psychological status (the hospital anxiety and depression scale [HADS]), and ultrasonographic assessments of urethral structure and mobility (e.g. external urethral sphincter thickness, urethral width, sphincter volume, and urethral mobility).
Results This is a protocol paper; results are not yet available and will be reported in the primary publication.
Conclusion This protocol aims to evaluate whether ultrasound-guided UBD is a feasible and clinically useful option for managing urinary retention after SCI. The findings will provide preliminary evidence to inform its future clinical application.
Keywords: Spinal cord injury, Urinary retention, Ultrasound, Urethral balloon dilation, Randomized controlled trial, Zelen design
Type of Study: Original |
Subject:
Physical Medicine
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This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 (CC-By-NC 4.0), which permits use, distribution, and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
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