A matched and controlled longitudinal cohort study of dehydrated human amniotic membrane allograft sheet used as a wraparound nerve bundles in robotic-assisted laparoscopic radical prostatectomy: a puissant adjunct for enhanced potency outcomes

摘要

We sought to explore the potency outcomes in two systematically controlled, non-randomized, matched, homogenous patient cohorts, which either underwent intervention (INT) with placement of dehydrated human amniotic membrane (dHAM) around nerve bundles (NVB) during robotic-assisted laparoscopic radical prostatectomy (RALP) or did not (CON). It is hypothesized that dHAM use would lead to better potency outcomes. 1400 eligible informed, consented patients underwent full bilateral nerve-sparing RALP by a single surgeon, wherein 700 patients had dHAM allograft wrapped around the NVB and 700 did not. Groups were matched demographically, clinically, and biochemically. Potency was defined as the ability to have satisfactory penetrative intercourse > 50% of time with SHIM score of ≥ 17 with or without of phosphodiesterase-5 inhibitors. A retrospective matched longitudinal cohort study was performed at 1 year. The first noticeable erection sufficient enough for a satisfactory penetrative intercourse was significantly earlier (p<0.01; 34.6±3.6 days), whereas the decrease in SHIM score was lower (4.27 ±0.14 days) in INT. Binary logistic regression demonstrated that INT was an independent significant (p<0.001) predictor of achieving potency at 1 year, such that INT was 3.86 times (95% CI 2.43-6.13) more likely to achieve potency in the same period when compared with CON. Chi square analysis demonstrated that recovery of potency in INT was better (p<0.05) in every quarter compared to CON. A higher (p< 0.005) percentage (93.1%) of INT regained potency versus CON (87.1%) at 1 year.