Vardenafil can improve continence recovery after bilateral nerve sparing prostatectomy: Results of a randomized, double blind, placebo-controlled pilot study

Mauro Gacci, Alessandro Ierardi, Augusto Delle Rose, Stefano Tazzioli, Emanuele Scapaticci, Sandra Filippi, Mario Maggi, Giulio Nicita, Marco Carini, Francesco Montorsi

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Phosphodiesterase type 5 inhibitors (PDE5-I) have acquired an established role in the treatment of post-prostatectomy erectile dysfunction (ED). Several trials in men with ED and lower urinary tract symptoms associated with benign prostatic hyperplasia suggest that PDE5-I could improve both erectile function and urinary symptoms. Aim: To assess the role of vardenafil in continence recovery after bilateral nerve sparing radical prostatectomy (BNS-RP). Methods: Thirty-nine patients with prostate cancer were recruited. After BNS-RP, patients were double-blinded assigned to three arms: a) vardenafil on demand; b) vardenafil nightly; and c) placebo. Main Outcomes Measures: Urinary function (UF) and urinary bother (UB) of University of California-Los Angeles Prostate Cancer Index questionnaire were assessed preoperatively and at 1, 3, 6, 9, 10, and 12 months. Twelve-month outcomes were compared to 1 month with a t-test. The differences in UF and UB (at 3, 6, 9, 10, and 12 months) between the three treatment arms were calculated by an analysis of variance. With ALLFIT we estimated half-maximal recovery times (ER50) and maximal recovery (Rmax) in three groups. Results: The improvement of UF and UB between 1 and 12 months was significant in all arms except for placebo (UF: P = 0.125; UB: P = 0.089). Nightly resulted in greater UF at 3, 6, and 9 months and greater UB at 6 months compared with placebo (P = 0.042, P = 0.044 and P = 0.039); after nightly administration, patients presented higher UB than after on-demand use, 3 and 6 months postoperatively (P = 0.036 and P = 0.017). ALLFIT demonstrated a similar ER50 in all groups (2.6 months for both UF and UB) and indicated that nightly administration induced significant improvements in Rmax compared with placebo (both

Original languageEnglish
Pages (from-to)234-243
Number of pages10
JournalJournal of Sexual Medicine
Volume7
Issue number1 PART 1
DOIs
Publication statusPublished - Jan 2010

Keywords

  • Bilateral nerve sparing
  • PDE5-I
  • Prostate cancer
  • Radical prostatectomy
  • Urinary continence rehabilitation
  • Vardenafil

ASJC Scopus subject areas

  • Urology
  • Obstetrics and Gynaecology
  • Reproductive Medicine

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