Buccal mucosa graft versus MukoCell® technique urethroplasty: a randomized open-label clinical trial

Abstract

Background Urethral strictures are common and increasingly in ageing population, especially the bulbous urethral stricture. There are multiple causes, the main ones are iatrogenic and due to inflammation. Because of this there a large number of different treatments, depending on the localization, the length or even the cause. The main treatment in bulbar urethral strictures is the use of buccal mucosa graft urethroplasty, which is one of the recent developments in urethral surgery, even thought, it still has some perks, like the oral complications underlying, and the fact that it cannot be used in extensive strictures, due to the limited extension of oral mucosa. Looking forward to the future a real gate opens with the application of tissue engineering to obtain oral mucosa, the main product now is MukoCell®. This new TEBM would diminish all the complications regarding the buccal mucosa harvest,such as are swelling and scarring, injuries to the salivary gland orifices, and problems with the intake of food and restriction of the opening of the mouth. Objective The aim of this study is to register and compare the post-intervention outcomes in the different functional tests in patients undergoing the urethroplasty using the MukoCell® compared to those who received the classical procedure, the buccal mucosa graft urethroplasty. Design This study will be a prospective, randomized, open-label and controlled clinical trial carried out in Hospital Universitari Doctor Josep Trueta from February 2021 until October 2029. Intervention and Methods For 8 years and 9 months, a total of 132 patients diagnosed with a bulbar urethral stricture

(>2,5 cm length) in the Hospital Dr. Josep Trueta will be recruited using a consecutive non- probabilistic method and will randomly be assigned with a ratio of 1:1 to undergo an

urethroplasty using BMG grafts (group control) and urethroplasty with MukoCell® (by UroTiss Europe GmbH) as the intervention group