Evaluating Nerve Wrapping with Multi-Layer Perinatal Tissue Allograft During Nerve-Sparing Robot-Assisted Radical Prostatectomy for Localized Prostate Cancer

What this Trial Is About

Researchers are studying whether a new multi-layer perinatal tissue allograft called MLG-Complete can help reduce complications after nerve-sparing robot-assisted radical prostatectomy RARP in men with localized prostate cancer. This condition involves prostate cancer that has not spread beyond the prostate, and the study aims to improve quality of life by addressing common side effects such as erectile dysfunction and urinary incontinence that can occur despite nerve-sparing surgery. Participants will receive the MLG-Complete allograft placed on nerve bundles during standard nerve-sparing RARP surgery. The allograft is intended to act as a protective barrier for the nerves and surrounding tissues. This procedure lasts about five minutes and is part of the surgical process. The study focuses on supporting recovery and function after surgery. During the study, participants will be monitored for safety and effectiveness of the allograft placement, including tracking operative time and any serious adverse events up to six weeks after surgery. Researchers will also assess recovery of potency and continence, quality of life, and urinary function through surveys and evaluations at baseline, 6 weeks, and 3, 6, and 12 months post-surgery. Follow-up will include reviewing healthcare interactions and cost analysis up to one year after surgery.

Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy