INGENIERIA TISULAR DE MUCOSA BUCAL EN URETRA
EBioMedicine. 2017 Aug 16. pii: S2352-3964(17)30331-6. doi: 10.1016/j.ebiom.2017.08.014. [Epub ahead of print]
Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial.
Ram-Liebig G1, Barbagli G2, Heidenreich A3, Fahlenkamp D4, Romano G5, Rebmann U6, Standhaft D6, van Ahlen H7, Schakaki S7, Balsmeyer U4, Spiegeler ME8, Knispel H8.
Harvest of oral mucosa for urethroplasty due to urethral stricture is associated with donor-site-morbidity. We assessed functionality and safety of an authorized tissue-engineered oral mucosa graft (TEOMG) under routine practice in stricture recurrences of any etiology, location, length and severity (real-world data).
99 patients from eight centers with heterogenous urethroplasty experience levels were included in this prospective, non-interventional observational study. Primary and secondary outcomes were success rate (SR) and safety at 12 and 24months.
All but one patient had ≥1, 77.1% (64 of 83)≥2 and 31.3% (26 of 83)≥4 previous surgical treatments. Pre- and postoperative mean±SD peak flow rate (Qmax) were 8.3±4.7mL/s (n=57) and 25.4±14.7mL/s (n=51). SR was 67.3% (95% CI 57.6-77.0) at 12 and 58.2% (95% CI 47.7-68.7) at 24months (conservative Kaplan Meier assessment). SR ranged between 85.7% and 0% in case of high and low surgical experience. Simple proportions of 12-month and 24-month SR for evaluable patients in all centers were 70.8% (46 of 65) and 76.9% (30 of 39). Except for one patient, no oral adverse event was reported.
TEOMG is safe and efficient in urethroplasty.