A prospective, randomized, placebo-controlled trial of on-Demand vs. nightly XXXX as assessed by Rigiscan and the international index of erectile function.

@entity1 @entity7856 @entity2003 @entity263 @entity7855
Multiple studies have evaluated the use of @entity7856 inhibitors in penile rehabilitation following nerve-sparing prostatectomy. These studies have evaluated the use of various pharmacologic agents as well as various approaches to treatment (on-demand vs. rehabilitative). Most of these studies relied on self-reported outcomes to determine efficacy of the therapy which could allow response bias to affect their results. The aim of this study was to evaluate the effects of nightly @entity7855 therapy during penile rehabilitation, using @entity2003 (RigiScan(   ) , Gotop Medical, Inc., St. Paul, MN, USA) in addition to the IIEF-EF. @entity1 with @entity263 and normal erectile function prior to nsRP were randomized to take either nightly 50  mg @entity7855 or placebo starting the night following surgery. Both groups were allowed on-demand @entity7855 . Erectile function was evaluated at 2  weeks, 3, 6, 9 and 12  months post-operatively, with a final assessment made at 13  months, following a 1  month drug washout. At all time points, self-reported (IIEF-EF) and objective (RigiScan(   ) ) measures were obtained and evaluated. About 74 of 97 randomized @entity1 completed the study. On completion, 40% of @entity1 in each group had normal erectile function based on RigiScan(   ) (p  =  1.0). Additionally, no statistical differences were seen using the IIEF-EF domain (32.4% of placebo, 29% of treatment; p  =  0.79). Multivariable analysis showed no significant differences in erectile function based on treatment intervention. Results did show that African-American @entity1 in this cohort were at higher risk for lower RigiScan(   ) scores over time (OR: 0.48, p  =  0.0399). This study demonstrates that nightly @entity7855 does not provide a therapeutic benefit for recovery of erectile function post-prostatectomy when compared to on-demand dosing using both self-reported as well as objective measures. Differences in objective recovery parameters based on @entity1 ' race/ethnicity warrant further investigation.
