Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060937) titled 'Retrospective observational study on success factors and prognosis of re-trial without catheter in patients with persistent urinary retention' on April 1.
Study Type:
Observational
Primary Sponsor:
Institute - Akashi Ninjyu Hospital
Condition:
Condition - Persistent urinary retention
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In older adults, indwelling urethral catheterization for urinary retention is associated with an increased risk of urinary tract infections and a decline in quality of life; therefore, catheter removal to restore spontaneous voiding is strongly recommended. However, in patients with persistent urinary retention who require re-catheterization following an initial failed trial without catheter (TWOC), the optimal endpoint for repeated TWOC attempts and the specific predictors for successful complete spontaneous voiding remain poorly defined. Utilizing retrospective data from patients enrolled in our urinary independence support program, this study investigates the physical and clinical risk factors predicting complete spontaneous voiding. Furthermore, we will evaluate the overall survival of patients with unresolved urinary retention and the clinical safety of repeated TWOC procedures. Ultimately, this study seeks to establish evidence-based criteria for TWOC decision-making, thereby contributing to safer and more effective urinary management strategies for elderly patients.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients who meet all of the following criteria:
1. Entered into the Urinary Independence Support program at our institution.
2. Underwent an initial trial without catheter (TWOC) at a previous hospital or our institution, but required re-catheterization due to increased residual urine or urinary retention.
2. Planned for a second or subsequent TWOC.
Key exclusion criteria - Refusal to participate (opt-out).
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 13 Day
Date of IRB - 2026 Year 03 Month 13 Day
Anticipated trial start date - 2026 Year 03 Month 14 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069734
Disclaimer: Curated by HT Syndication.