The efficacy of a suppository based on Phenolmicin P3 and Bosexil (Mictalase®) in control of irritative symptoms in patients undergoing thulium laser enucleation of prostate: a single-center, randomized, controlled, open label, phase III study

BMC Urology

Riccardo Bertolo¹  Filomena Petta¹  Chiara Cipriani¹  Matteo Vittori¹  Valerio Iacovelli¹  Massimo Panei¹  Francesco Maiorino¹  Michele Antonucci¹  Marta Signoretti²  Marco Carilli³  Pierluigi Bove³  Carlo Ganini⁴ 

[1] Department of Urology, “San Carlo di Nancy” Hospital – GVM Care and Research, Via Aurelia 275, 00165, Rome, Italy;Department of Urology, “San Carlo di Nancy” Hospital – GVM Care and Research, Via Aurelia 275, 00165, Rome, Italy;Urology Unit, Department of Life, Health and Environmental Sciences, University of L’Aquila, Coppito, AQ, Italy;Department of Urology, “San Carlo di Nancy” Hospital – GVM Care and Research, Via Aurelia 275, 00165, Rome, Italy;Urology Unit, Department of Surgery, Tor Vergata University of Rome, Rome, Italy;Torvergata Oncoscience Research TOR, Department of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy;

关键词: Benign prostatic hyperplasia;    BPH;    Laser enucleation;    ThuLEP;    LUTS;    Urinary tract infections;   

DOI  :  10.1186/s12894-022-00974-0

来源: Springer

【 摘 要 】

BackgroundSeveral studies described post-operative irritative symptoms after laser enucleation of prostate, sometimes associated with urge incontinence, probably linked to laser-induced prostatic capsule irritation, and potential for lower urinary tract infections We aimed to evaluate the efficacy of a suppository based on Phenolmicin P3 and Bosexil (Mictalase®) in control of irritative symptoms in patients undergoing thulium laser enucleation of prostate (ThuLEP).MethodsIn this single-center, prospective, randomized, open label, phase-III study, patients with indication to ThuLEP were enrolled (Dec2019–Feb2021—Institutional ethics committee STS CE Lazio approval no.1/N-726—ClinicalTrials.gov NCT05130918). The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Mictalase® suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive Mictalase® (“controls”). Study endpoints were evaluated at 15 and 30 days postoperation. Primary endpoint included evaluation of effects of the suppository on irritative symptoms by administering IPSS + QoL questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.Results111 patients were randomized: 56 in Group A received Mictalase®. Baseline and perioperative data were comparable. At 15-days, no significant differences were found in terms of IPSS + QoL scores and urinalysis parameters. A significant difference in the rate of positive urine cultures favored Group A (p = 0.04). At 30-days follow-up, significant differences were found in median IPSS score (6 [IQR 3–11] versus 10 [5–13], Group A vs B, respectively, p = 0.02). Urinalysis parameters and rate of positive urine cultures were not significantly different.ConclusionsThe present randomized trial investigated the efficacy of Mictalase® in control of irritative symptoms and prevention of lower urinary tract infections in patients undergoing ThuLEP. IPSS improvement 30-days postoperation was more pronounced in patients who received Mictalase®. Lower rate of positive urine culture favored Mictalase® group 15-days postoperatively.Trial registrationThe clinical trial has been registered on ClinicalTrials.gov on November 23rd, 2021—Registration number NCT05130918.

【 授权许可】

CC BY