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
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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.
KeywordsProstatectomy Amnion Allografts Longitudinal study
Sexual Health Inventory for Men Questionnaire
Robot-assisted laparoscopic radical prostatectomy
Dehydrated human amniotic membrane
Compliance with ethical standards
Authors Rajesh Raj Bajpai, Shirin Razdan, Marcos A Sanchez and Sanjay Razdan declare that they have no financial disclosure to make.
Conflict of interest
Authors Rajesh Raj Bajpai, Shirin Razdan, Marcos A Sanchez and Sanjay Razdan declare that they have no conflict of interest.
Informed consent was obtained from all participating individuals in this study.
All procedures performed in the studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration ns the later amendments or comparable ethical standards.
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