Tadalafil in the treatment of erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy: A randomized, double-blind, placebo controlled trial

Francesco Montorsi, Harin Padma Nathan, Andrew McCullough, Gerald B. Brock, Gregory Broderick, Sanjeev Ahuja, Steve Whitaker, Amy Hoover, Donna Novack, Aileen Murphy, Lucio Varanese

Research output: Contribution to journalArticle

Abstract

Purpose: We evaluated the efficacy and safety of tadalafil 20 mg, taken on demand, in men with erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy (BNSRRP). Materials and Methods: This randomized, double-blind, placebo controlled multicenter study consisted of a 4-week treatment-free run-in period (baseline) followed by 12 weeks of treatment. A total of 303 men (mean age 60 years) with preoperative normal erectile function who had undergone a BNSRRP 12 to 48 months before study were randomized (2:1) to tadalafil (201) or placebo (102). The 3 co-primary end points were changes from baseline in the International Index of Erectile Function erectile function domain score, and the percentage of positive responses to Sexual Encounter Profile questions 2 (successful penetration) and 3 (successful intercourse). The Global Assessment Question and the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire were secondary end points. We defined a priori a subgroup of 201 patients reporting evidence of postoperative tumescence, defined as 50% or greater "yes" responses to Sexual Encounter Profile question 1 (ability to achieve at least some erection) during baseline intercourse attempts and stratified randomization based on this criterion. Results: Patients receiving tadalafil reported greater improvement on all primary and secondary end points (p

Original languageEnglish
Pages (from-to)1036-1041
Number of pages6
JournalJournal of Urology
Volume172
Issue number3
DOIs
Publication statusPublished - Sep 2004

Keywords

  • Impotence
  • Phosphodiesterase inhibitors
  • Prostatectomy
  • Prostatic neoplasms

ASJC Scopus subject areas

  • Urology

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    Montorsi, F., Nathan, H. P., McCullough, A., Brock, G. B., Broderick, G., Ahuja, S., Whitaker, S., Hoover, A., Novack, D., Murphy, A., & Varanese, L. (2004). Tadalafil in the treatment of erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy: A randomized, double-blind, placebo controlled trial. Journal of Urology, 172(3), 1036-1041. https://doi.org/10.1097/01.ju.0000136448.71773.2b