OBJECTIVES: To report pre-specified and exploratory results on the effect of different surgical approaches on erectile function (EF) after nerve-sparing radical prostatectomy (nsRP) obtained from the multicenter, randomized, double-blind, double-dummy REACTT trial of tadalafil (once a day [OaD] or on-demand [pro-re-nata, PRN]) versus placebo.
PATIENTS AND METHODS: Patients < 68yrs with normal preoperative EF who underwent nsRP for localized prostate cancer (Gleason ≤ 7, PSA < 10ng/mL) were randomized post-nsRP 1:1:1 to 9-month double-blind treatment (DBT) with tadalafil 5mg OaD, tadalafil 20mg PRN, or placebo, followed by 6-week drug-free washout, and 3-month open-label OaD treatment (all patients). EF-recovery was defined as an International Index of Erectile Function (IIEF)-EF domain score ≥22, and normal orgasmic function was defined based on IIEF Question 10. Both parameters were analyzed at the end of washout using logistic regression including terms for: treatment, country, visit, visit-by-treatment interaction, age group, nerve-sparing score (perfect =2, non-perfect >2), and surgical approach (open surgery, robot-assisted laparoscopy, conventional laparoscopy, other). Time to EF-recovery was analyzed post-hoc with a Cox proportional-hazards model including terms for: treatment, age-group, country, surgical approach, and surgery-by-treatment interaction.
RESULTS: Of 422 patients treated, 189 underwent open surgery, 115 robot-assisted laparoscopy, 88 conventional laparoscopy, and 30 surgery classified as "other". The odds of achieving EF-recovery at the end of drug-free washout were approximately twice as high for the robot-assisted laparoscopy group compared with the open surgery group (odds ratio: 2.42; 95%CI 1.24, 4.72; p=0.029). Patients who underwent robot-assisted laparoscopy were significantly more likely to recover during DBT compared with patients who underwent open surgery (hazard ratio: 1.92; 95%CI 1.17, 3.15; p=0.010). A favourable effect of conventional laparoscopy compared with open surgery could not be observed.
CONCLUSION: These results may provide further insights into the role of surgery on EF-recovery post-nsRP. However, the trial was not designed for these analyses and further prospective studies are needed.
Written by:
Stolzenburg JU, Graefen M, Kriegel C, Michl U, Morales AM, Pommerville PJ, Manning M, Büttner H, Henneges C, Schostak M. Are you the author?
Department of Urology, University Hospital Leipzig, Germany.
Reference: BJU Int. 2015 Jan 5. Epub ahead of print.
doi: 10.1111/bju.13030
PubMed Abstract
PMID: 25560809