PD27-09: Preliminary Findings of a Prospective, Randomized Controlled Pilot Study Evaluating the Recovery of Potency and Continence Following Robotic Prostatectomy with and without Umbilical Cord Allograft

Tanner Corse*, Mutahar Ahmed, Linda Dayan, Jay Zaifman, Nutley, NJ, Michael Degen, Hackensack, NJ, Ravi Munver, Michael Stifelman, Nutley, NJ

Introduction: Several retrospective non-randomized case series have demonstrated enhanced recovery of potency and continence following robotic-assisted radical prostatectomy (RARP) when placing human amniotic membrane or umbilical cord allograft over the neurovascular bundle. This study is the first prospective, randomized controlled trial evaluating the use of cryopreserved umbilical grafts (cUC) in patients undergoing RARP.

Methods: This is an ongoing investigator-initiated, patient-blinded, prospective, controlled pilot study (NCT04263025) of 48 patients (cUC=23, control=25) with organ-confined prostate cancer. Patients must meet inclusion criteria of International Consultation of Incontinence Questionnaire-Short Form (ICIQ-SF) <6 and International Index of Erectile Function (IIEF-6) scores =26. Eligible patients are randomized 1:1 to undergo bilateral, nerve-sparing RARP with or without cUC. The primary endpoint is the proportion of patients achieving recovery of erectile function (defined as IIEF-6 = 24) at 3-months postoperatively. Secondary outcomes include IIEF-6 score, ICIQ-SF score, number of pads per day (PPD), pad weight in grams, biochemical recurrence (BCR).

Results: As of October 10, 2021, 32 patients (cUC=16, control=16) have reached 3 month postoperative follow up. Demographics and preoperative patient characteristics did not significantly differ between groups. 7 patients (43.75%) who received cUC and 3 patients (23.1%) in the control group reported achieving recovery of erectile function (p=0.440). Additionally, 8 patients (50.0%) in the cUC group and 3 patients (23.1%) in the control group reported IIEF-6=17 (p=0.271). The average change from baseline IIEF-6 score was -13.5 in the cUC group and -19.2 in the control (p=0.214). Both groups averaged 0.9 PPD with the average pad weights being 13.9 g and 33.0 g in the cUC and control groups, respectively (p=0.172). No cUC patients experienced BCR, while there was one case in control at 3-months.

Conclusions: Early results demonstrate that adjunctive use of cryopreserved umbilical grafts in RARP is safe. Our preliminary analysis showed a trend toward improved recovery of erectile function at 3 month followup utilizing cUC following RARP, but do not show statistical significance. Higher powered analyses with longer follow up are needed to determine the potential benefits in this setting.

Source of Funding: TissueTech, Inc.