MP48-10 TADALAFIL ONCE A DAY SIGNIFICANTLY REDUCES PENILE LENGTH-LOSS IN PATIENTS POST BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY (NSRP) - RESULTS FROM A RANDOMIZED CONTROLLED TRIAL

Abstract

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Non-surgical1 Apr 2014MP48-10 TADALAFIL ONCE A DAY SIGNIFICANTLY REDUCES PENILE LENGTH-LOSS IN PATIENTS POST BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY (NSRP) - RESULTS FROM A RANDOMIZED CONTROLLED TRIAL Gerald Brock, Francesco Montorsi, Pierre Costa, Nimish Shah, Jose Maria Martinez Jabaloyas, Peter Hammerer, Giuseppe M. Ludovico, Carsten Henneges, Karim Hamidi, Andrea Rossi, Hartwig Büttner, and John Mulhall Gerald BrockGerald Brock More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , Pierre CostaPierre Costa More articles by this author , Nimish ShahNimish Shah More articles by this author , Jose Maria Martinez JabaloyasJose Maria Martinez Jabaloyas More articles by this author , Peter HammererPeter Hammerer More articles by this author , Giuseppe M. LudovicoGiuseppe M. Ludovico More articles by this author , Carsten HennegesCarsten Henneges More articles by this author , Karim HamidiKarim Hamidi More articles by this author , Andrea RossiAndrea Rossi More articles by this author , Hartwig BüttnerHartwig Büttner More articles by this author , and John MulhallJohn Mulhall More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1484AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction and Objectives Secondary analyses on stretched penile length (SPL) data from a multicenter, randomized, double-blind, double-dummy, placebo (PLC) controlled clinical trial (NCT01026818) evaluating the efficacy of tadalafil (TAD) initiated post-nsRP are reported. Methods Patients (pts) ≤68yrs with normal preoperative erectile function (EF) who underwent nsRP for localized prostate cancer (Gleason ≤7, PSA <10ng/mL) were randomized post nsRP 1:1:1 to 9-month (mo) double-blind treatment (DBT) with TAD 5mg once a day (OaD), 20mg TAD on demand (pro re nata; PRN), or PLC, followed by 6-week drug-free washout (DFW)and 3mo open-label OaD treatment (OLT, all pts). Secondary outcome measures included change of SPL from baseline (nsRP) to end of 9mo DBT (eDBT)(LS mean change compared by prespecified ANCOVA, including terms for treatment, country, baseline, age, and Nerve Sparing Score [NSS]), responses to Sexual Encounter Profile Questions (SEP) 1 and 3 (mixed model for repeated measures including terms for treatment, country, visit, visit-treatment interaction, age) and the Standardized Morning Erection Question (SMEQ; Cochrane Mantel Haenszel test adjusted for age and country). Results 423 pts were randomized to OaD (N=139), PRN (N=143), and PLC (N=141); 114/122/155 completed 9mo DBT. Greater retained SPL was observed with OaD vs PLC at eDBT (Figure; LS mean [95%CI] difference OaD vs PLC, 4.1 [0.4, 7.8] mm, p=0.032). No significant LS mean difference (p >0.05) was observed for PRN vs PLC. No significant effect of NSS on SPL loss was observed (Figure). Penile tumescense (SEP 1) as the initial sign of EF recovery was improved significantly vs. PLC at eDBT and OLT for pts randomized to OaD only. The ability for sexual intercourse (SEP 3) also significantly improved for pts on OaD vs placebo only at eDBT. The distribution of SMEQ responses was different at eDBT (p=0.045), with 34.2% of pts on OaD, 50.0% on PRN and 56.5% on PLC reporting the absence of morning erections, At eDFW, SEP responses were not statistically significantly different between OaD and PLC. Conclusions These data suggest that the early initiation of treatment with TAD OaD protects from penile length-loss and may contribute to protection from structural cavernosal changes post nsRP. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e530-e531 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Gerald Brock More articles by this author Francesco Montorsi More articles by this author Pierre Costa More articles by this author Nimish Shah More articles by this author Jose Maria Martinez Jabaloyas More articles by this author Peter Hammerer More articles by this author Giuseppe M. Ludovico More articles by this author Carsten Henneges More articles by this author Karim Hamidi More articles by this author Andrea Rossi More articles by this author Hartwig Büttner More articles by this author John Mulhall More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...