title: Effect of Tadalafil Once Daily on Penile Length Loss and Morning Erections in Patients After Bilateral Nerve-sparing Radical Prostatectomy: Results From a Randomized Controlled Trial.
abstract: OBJECTIVE
  To report penile integrity measures, including stretched penile length (SPL), from a randomized, double-blind, double-dummy, placebo-controlled trial evaluating treatment with tadalafil initiated after nerve-sparing radical prostatectomy (nsRP).
  
  
  METHODS
  Patients aged ≤ 68 years were randomized after nsRP 1:1:1 to 9-month double-blind treatment (DBT) with tadalafil 5 mg once daily (OaD), 20-mg tadalafil on-demand ("pro-re-nata"; PRN), or placebo, followed by 6-week drug-free washout and 3-month open-label OaD treatment. Secondary outcome measures included the change in SPL from pre-nsRP to the end of DBT (analysis of covariance adjusting for treatment, country, baseline, age, and nerve-sparing score), responses to Sexual Encounter Profile (SEP) questions 1-3 (mixed models for repeated measures adjusting for treatment, country, visit, visit-treatment-interaction, age), and Standardized Morning Erection Question (Cochran-Mantel-Haenszel test adjusted for age and country).
  
  
  RESULTS
  Four hundred twenty-three patients were randomized to tadalafil OaD (N = 139), tadalafil PRN (N = 143), and placebo (N = 141). Greater retainment of SPL was observed with tadalafil OaD vs placebo at the end of DBT (least-square mean [95% confidence interval] difference OaD vs placebo, 4.1 mm [0.4 to 7.8 mm]; P = .032). No significant effects on SPL were found for tadalafil PRN vs placebo, or for the nerve-sparing score. Penile tumescence (SEP1) and ability for vaginal insertion (SEP2) significantly improved vs placebo at the end of double-blind and open-label treatment for patients randomized to tadalafil OaD only. The ability for successful sexual intercourse (SEP3) significantly improved with tadalafil OaD vs placebo only during DBT. The distribution of Standardized Morning Erection Question responses was different at the end of DBT (P = .045); 34.2% of patients on tadalafil OaD, 50.0% on tadalafil PRN, and 56.5% on placebo reported absence of morning erections.
  
  
  CONCLUSIONS
  These data suggest the early initiation of tadalafil OaD protects from penile length loss and may contribute to protection from structural cavernosal changes after nsRP.
authors: Department of Surgery, Division of Urology, St. Joseph's Health Centre, University of Western Ontario, London, Ontario, Canada. Electronic address: gebrock@sympatico.ca.
authors: Gerald
authors: G
authors: Brock
authors: Department of Urology, Vita-Salute San Raffaele University, Milan, Italy.
authors: Francesco
authors: F
authors: Montorsi
authors: Department of Urology and Andrology, Academic Hospital Caremau, Montpellier Université I, Nîmes, France.
authors: Pierre
authors: P
authors: Costa
authors: Department of Urology, Addenbrooke's Hospital, Cambridge, United Kingdom.
authors: Nimish
authors: N
authors: Shah
authors: Department of Urology, University Hospital, Valencia, Spain.
authors: Jose Maria
authors: JM
authors: Martinez-Jabaloyas
authors: Department of Urology, Städtisches Klinikum Braunschweig gGmbH, Braunschweig, Germany.
authors: Peter
authors: P
authors: Hammerer
authors: Department of Urology and Robotic Surgery, Miulli Hospital, Acquaviva delle Fonti, Bari, Italy.
authors: Giuseppe M
authors: GM
authors: Ludovico
authors: Department of Surgery, Division of Urology, Southern Alberta Institute of Urology, Calgary, Canada.
authors: Jay C
authors: JC
authors: Lee
authors: Therapeutic Area Men's Health, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors: Carsten
authors: C
authors: Henneges
authors: Therapeutic area Men's Health, Eli Lilly and Company, Neuilly-sur-Seine, France.
authors: Karim
authors: K
authors: Hamidi
authors: Eli Lilly S.p.A., Florence, Italy.
authors: Andrea
authors: A
authors: Rossi
authors: Department of Urology, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors: John
authors: J
authors: Mulhall
authors: Therapeutic Area Men's Health, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors: Hartwig
authors: H
authors: Büttner
mesh_terms: D000368:Aged; D002243:Carbolines / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D008875:Middle Aged; D009929:Organ Size / Q000187:drug effects; D059351:Organ Sparing Treatments; D010410:Penile Erection / Q000187:drug effects*; D010413:Penis / Q000033:anatomy & histology* / Q000187:drug effects*; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage*; D011467:Prostate / Q000294:innervation / Q000601:surgery; D011468:Prostatectomy / Q000379:methods*; D020127:Recovery of Function; D000068581:Tadalafil
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil