Mp06-02 Phase-1 Human Trial: Endoscopic Liquid Buccal Mucosal Graft Urethroplasty, Early Outcomes

You have accessJournal of UrologyReconstruction: Urethral Reconstruction (including stricture) I (MP06)1 May 2024MP06-02 PHASE-1 HUMAN TRIAL: ENDOSCOPIC LIQUID BUCCAL MUCOSAL GRAFT URETHROPLASTY, EARLY OUTCOMES Guanqun Li, Elizabeth Bearrick, and Dmitriy Nikolavsky Guanqun LiGuanqun Li , Elizabeth BearrickElizabeth Bearrick , and Dmitriy NikolavskyDmitriy Nikolavsky View All Author Informationhttps://doi.org/10.1097/01.JU.0001009452.79331.fd.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Endoscopic treatment of urethral stricture with direct vision internal urethrotomy (DVIU), while minimally invasive, has high failure rates. Conversely, open urethroplasty, though more invasive, offers greater long-term success. In rabbit model, we previously showed the efficacy of liquid buccal mucosa graft (LBMG) augmented DVIU. In this study, we aim to report our experience on human LBMG augmented DVIU. METHODS: After an IRB approval, a single-institution prospective Phase-1 trial was conducted, enrolling males aged 18 and older with at least one prior endoscopic treatment failure (DVIU, dilation). Those with prior urethroplasty were excluded. DVIU was performed followed by placing a 16 Fr catheter. BMG was then harvested, defatted, sharply minced to <5mm fragments and suspended in 4cc NS. This solution was then introduced over the DVIU defect via an 8 Fr catheter passed adjacent to the 16 Fr catheter (peri-catheter injection). The penis was maintained in an upright position for 10 mins allowing for micrograft settling and attachment. Catheter was removed 1 week later and patients were seen at 3-month intervals for the first year and yearly thereafter. PROMS, Uroflow and PVR were assessed at each visit. Cystoscopy was performed at 12 months. The primary endpoint was perioperative safety, monitoring for adverse events (AEs). Secondary outcomes included functional success, defined as absence of any need for additional procedures, voiding and sexual outcomes and patient satisfaction. RESULTS: Nine patients with a median age of 29 (20-45) were included. All patients had at least one prior failed endoscopic intervention. All strictures were in the bulbar urethra, mean length of 1.7cm (1-2cm). No intraoperative or postoperative AEs occurred within 90 days flowing surgery. The mean surgical duration was 54 mins (43-61 mins). All patients were discharged on the same day. The mean follow-up period was 18 mos (4-92 mos).Patients experienced significant improvements, including increased maximal urinary flow (7.2cc/s to 20.2cc/s, p=0.00044), reduced post-void residual volume (212cc to 85cc, p=0.014), and improved International Prostate Symptom Score (IPSS) from 20 to 6 (p=0.000035). There were no observed differences in sexual function post-surgery, and all patients reported an enhanced quality of life on the quality of life (QoL) questionnaire (p=0.00011). The functional success rates were 66.67%, with 3 patients experiencing recurrence at a mean of 9 months, subsequently treated with urethroplasty. There was no measurable change in stricture length in 3 patients who failed. CONCLUSIONS: This novel prospective human study demonstrates feasibility, safety, and early success of LBMG augmented DVIU. Further studies are needed to validate these findings and optimize the procedure. Source of Funding: N/A © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e51 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Guanqun Li More articles by this author Elizabeth Bearrick More articles by this author Dmitriy Nikolavsky More articles by this author Expand All Advertisement PDF downloadLoading ...