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Erectile function recovery in men treated with phosphodiesterase type 5 inhibitor administration after bilateral nerve‐sparing radical prostatectomy: a systematic review of placebo‐controlled randomized trials with trial sequential analysis
Author(s) -
Limoncin E.,
Gravina G. L.,
Corona G.,
Maggi M.,
Ciocca G.,
Lenzi A.,
Jannini E. A.
Publication year - 2017
Publication title -
andrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.947
H-Index - 43
eISSN - 2047-2927
pISSN - 2047-2919
DOI - 10.1111/andr.12403
Subject(s) - tadalafil , vardenafil , medicine , placebo , randomized controlled trial , erectile dysfunction , prostatectomy , urology , clinical trial , cgmp specific phosphodiesterase type 5 , surgery , prostate , alternative medicine , pathology , cancer
Summary The impact of phosphodiesterase type 5 inhibitor ( PDE 5I) treatment modality (on‐demand vs. daily), PDE 5I half‐life and time from surgery to PDE 5I prescription on the achievement of drug‐assisted erectile function ( EF ) recovery is uncertain. We systematically reviewed published randomized clinical trials ( RCT s). We performed meta‐analyses of data on 2317 men treated with PDE 5Is after nerve‐sparing radical prostatectomy ( NSRP ). A PubMed and SCOPUS search was performed for trials published from 1 January 1969 to 30 June 2016. PDE 5Is are effective in achieving drug‐assisted recovery of erectile function ( EF ). From a statistical standpoint, these studies were subjected to Trial Sequential Analysis to determine whether the pooled data were adequately powered to verify the study outcomes. On‐demand treatment with PDE 5Is was significantly better than daily treatment in recovering drug‐assisted EF . This effect was maintained even when the drugs were stratified according with half‐life. Although not based on head‐to‐head trials, Avanafil used on‐demand was the most effective PDE 5I in recovering drug‐assisted EF . Whereas tadalafil was equally effective when used both on‐demand and daily, vardenafil significantly improved drug‐assisted EF recovery only when used on‐demand. The start of PDE 5I treatment six months or more after surgery compared to treatment started earlier did not negatively affect the rate of drug‐assisted EF recovery or the possibility to have successful intercourse based on the Sexual Encounter Profile question‐3 ( SEP ‐3). Current trials do not support the hypothesis that PDE 5I use recovers drug‐unassisted EF , although chronic low‐dose tadalafil administration may help to preserve erectile tissue integrity. Potential shortcomings in the trials design may partially explain these disappointing results and several questions concerning the recovery of drug‐unassisted EF remain unanswered. Thus, there is a need for well‐designed new RCT s requiring changes in the timing of PDE 5I administration as well as in the dose and the treatment duration.