Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060408) titled 'Prospective Single-Arm Study of Anatomical Success after Heineke-Mikulicz Urethroplasty' on Feb. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Fujisawa Shonandai hospital
Condition:
Condition - urethral stricture
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to prospectively evaluate the anatomical success rate and safety of Heineke-Mikulicz urethroplasty for proximal bulbar or membranous urethral strictures.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Heineke-Mikulicz urethroplasty
Eligibility:
Age-lower limit - 18
years-old
= 18 years at the time of informed consent
3. A single stricture located in the proximal bulbar or membranous urethra on preoperative retrograde urethrography
4. Intraoperative measurement confirming a stricture length of =< 10 mm
5. Provision of written informed consent to participate in this study
Key exclusion criteria - 1. Urethral stricture associated with lichen sclerosus
2. Traumatic urethral stricture
3. History of prior urethroplasty, including childhood hypospadias repair
4. Complete obliteration of the urethral lumen
5. Multiple urethral strictures
6. Withdrawal of informed consent
Target Size - 79
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 14 Day
Anticipated trial start date - 2026 Year 02 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069108
Disclaimer: Curated by HT Syndication.
