title: Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study.
abstract: BACKGROUND
  This multicenter, randomized, double-blind, double-dummy, placebo-controlled trial primarily evaluated the efficacy of tadalafil once-daily (OaD) or on-demand ("pro-re-nata"; PRN) treatment, started early post-nsRP. Secondary outcome-measures on quality-of-life (QoL) and treatment satisfaction are reported.
  
  
  METHODS
  Patients, aged <68 yrs, with adenocarcinoma of the prostate (Gleason ≤ 7, normal preoperative erectile function [EF]) were randomized post-nsRP 1:1:1 to 9-month treatment with tadalafil 5 mg OaD, tadalafil 20 mg PRN, or placebo, followed by 6-week drug-free washout and 3-month open-label tadalafil OaD treatment (OLT). The main outcome measures were Changes in Expanded Prostate Cancer Index Composite (EPIC-26), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and Self-Esteem and Relationship (SEAR) questionnaires (mixed-model-for-repeated-measures, including terms for treatment, visit, treatment-by-visit interaction, age-group, country, baseline-score). LS means with 95% confidence interval (CI) are reported.
  
  
  RESULTS
  423 patients were randomized to 3 treatment-groups: tadalafil OaD (N = 139), PRN (N = 143), or placebo (N = 141). In each group, 57 (41.0%), 58 (40.6%), and 50 (35.5%) patients were aged 61-68 yrs. At the end of double-blind treatment (DBT), patients' EPIC sexual domain-scores improved significantly with tadalafil OaD versus placebo (treatment effect [95% CI]: 9.6 [3.1,16.0]; p = 0.004); comparisons of PRN versus placebo at end of DBT, and comparisons of tadalafil OaD and PRN versus placebo after OLT were not significant. Only in older patients (61-68 yrs; age-by-treatment p ≤ 0.1), EPIC urinary incontinence domain-scores also improved significantly with tadalafil OaD versus placebo (overall treatment effect across all visits, 8.3 [0.4,16.1]; p = 0.040). Treatment satisfaction increased significantly in both tadalafil groups, EDITS total-scores increased significantly with OaD and PRN versus placebo during DBT (p = 0.005 and p = 0.041, respectively). At the end of OLT, improvement was significant for tadalafil OaD versus placebo only (p = 0.035). No significant differences were observed for SEAR.
  
  
  CONCLUSIONS
  These results suggest that chronic dosing of tadalafil improves QoL of patients post-nsRP. The improvement of urinary incontinence in elderly patients randomized to tadalafil OaD may contribute to this effect.
  
  
  BACKGROUND
  www.clinicaltrials.gov , NCT01026818.
authors: Department of Urology, University Hospital North Norway, Sykehusvegen 38, 9038, Tromsø, Norway. urology@hrhpatel.org.
authors: Hitendra R
authors: HR
authors: Patel
authors: Lilly UK, Basingstoke, UK. ilo_dapo@lilly.com.
authors: Dapo
authors: D
authors: Ilo
authors: Addenbrooke's Hospital, Cambridge, UK. nimish.shah@addenbrookes.nhs.uk.
authors: Nimish
authors: N
authors: Shah
authors: Department of Urology, Edouard Herriot University Hospital, Lyon, France. cuzin.beatrice@gmail.com.
authors: Béatrice
authors: B
authors: Cuzin
authors: South Tees Hospitals NHS Foundation Trust, Stockton-on-Tees, UK. david.chadwick@stees.nhs.uk.
authors: David
authors: D
authors: Chadwick
authors: Centre Hospitalier Universitaire de Liège, Service d'Urologie, Belgium. robert.andrianne@chu.ulg.ac.be.
authors: Robert
authors: R
authors: Andrianne
authors: Lilly Deutschland GmbH, Bad Homburg, Germany. Henneges_carsten@lilly.com.
authors: Carsten
authors: C
authors: Henneges
authors: Lilly UK, Basingstoke, UK. jbarry@lilly.com.
authors: Jane
authors: J
authors: Barry
authors: Lilly Deutschland GmbH, Bad Homburg, Germany. hell-momeni_katja@lilly.com.
authors: Katja
authors: K
authors: Hell-Momeni
authors: Eli Lilly Polska, Warsaw, Poland. branicka_julia@lilly.com.
authors: Julia
authors: J
authors: Branicka
authors: Lilly Deutschland GmbH, Bad Homburg, Germany. Buettnerh@lilly.com.
authors: Hartwig
authors: H
authors: Büttner
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000601:surgery*; D000368:Aged; D004311:Double-Blind Method; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011468:Prostatectomy / Q000379:methods*; D011471:Prostatic Neoplasms / Q000188:drug therapy / Q000601:surgery; D011788:Quality of Life; D000068581:Tadalafil / Q000627:therapeutic use*; D014549:Urinary Incontinence / Q000517:prevention & control; D014665:Vasodilator Agents / Q000627:therapeutic use*
chemical_list: D014665:Vasodilator Agents; D000068581:Tadalafil