Primary endpoint was to objective a better effectiveness of flexible ureteroscopy (fURS) compared to extracorporeal shock wave lithotripsy (ESWL) 3 months after treatment of a unique kidney stone from 5 to 20mm.
Secondary endpoints were to evaluate effectiveness in subgroup and tolerance. We conducted a prospective comparative randomised trial between May 2012 and February 2014. A computerised tomography was done before treatment and another 3 months after treatment. Of the 30 randomised patients, 8 dropped out from the study and 4 were lost to follow-up. Median time of follow-up was 3.82 months. In per-protocol analysis, success rate was 60% for fURS group versus 28.6% for ESWL group (P=0.29). In intention to treat analysis, success rate was 77.8% in fURS group versus 53.8% in ESWL group (P=0.38). In ESWL group, 5 patients (41.7%) needed a second treatment versus none in fURS group but it was not significant. During follow-up, 1 patient in each group presented a complication. Results of this feasibility study did not allowed to conclude on superiority of a technic. A multicenter study with more important enrollment is necessary considering economic side and tolerance of these treatments.
Written by:
Ravier E, Abid N, Ruffion A, Fassi-Fehri H, Buron C, Ganne C, Mallet A, Martin X. Are you the author?
Service d'urologie et de chirurgie de la transplantation, hôpital Édouard-Herriot, 5, place d'Arsonval, 69003 Lyon, France; Service d'urologie, centre hospitalier Lyon-Sud, chemin du Grand-Revoyet, 69310 Pierre-Bénite, France; Pôle d'information médical, d'évaluation en santé et recherche clinique, hospices civils de Lyon, 162, avenue Lacassagne, 69003 Lyon, France; Unité de recherche clinique, hôpital de la Pitié-Salpêtrière, 47-83, boulevard de l'Hôpital, 75013 Paris, France.
Reference: Prog Urol. 2015 Jan 29. pii: S1166-7087(15)00006-8.
doi: 10.1016/j.purol.2015.01.005
PubMed Abstract
PMID: 25640027