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

• Published in: BMC urology Vol. 22; no. 1; pp. 19 - 10
• Main Authors: Bertolo, Riccardo, Cipriani, Chiara, Vittori, Matteo, Carilli, Marco, Maiorino, Francesco, Iacovelli, Valerio, Ganini, Carlo, Antonucci, Michele, Signoretti, Marta, Petta, Filomena, Panei, Massimo, Bove, Pierluigi
• Format: Journal Article
• Language: English
• Published: London BioMed Central 12.02.2022; BioMed Central Ltd; BMC
• Subjects: Aged; Analgesics; Analysis; Benign prostatic hyperplasia; BPH; Catheters; Clinical trials; Endoscopy; Enucleation; Health aspects; Humans; Internal Medicine; Intubation; Irritation; Labels; Laser enucleation; Lasers; Lasers in surgery; Lasers, Solid-State - adverse effects; Lasers, Solid-State - therapeutic use; Lower Urinary Tract Symptoms - drug therapy; Lower Urinary Tract Symptoms - etiology; Lower Urinary Tract Symptoms - prevention & control; LUTS; Male; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Middle Aged; Pain; Patients; Postoperative Complications - drug therapy; Postoperative Complications - prevention & control; Prospective Studies; Prostate; Prostate cancer; Prostatic Hyperplasia - complications; Prostatic Hyperplasia - surgery; Quality of life; Statistical analysis; Suppositories; ThuLEP; Thulium - adverse effects; Thulium - therapeutic use; Tumors; Urinalysis; Urinary incontinence; Urinary tract; Urinary tract diseases; Urinary tract infections; Urine; Urogenital system; Urological Agents - therapeutic use; Urology; Variables; ThuLEP; Benign prostatic hyperplasia; Urinary tract infections; BPH; LUTS; Laser enucleation
• ISSN: 1471-2490; 1471-2490
• DOI: 10.1186/s12894-022-00974-0

Background Several 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). Methods In 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. Results 111 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. Conclusions The 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 registration The clinical trial has been registered on ClinicalTrials.gov on November 23rd, 2021—Registration number NCT05130918.