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

Riccardo Bertolo, Chiara Cipriani, Matteo Vittori, Marco Carilli, Francesco Maiorino, Valerio Iacovelli, Carlo Ganini, Michele Antonucci, Marta Signoretti, Filomena Petta, Massimo Panei, Pierluigi Bove, Riccardo Bertolo, Chiara Cipriani, Matteo Vittori, Marco Carilli, Francesco Maiorino, Valerio Iacovelli, Carlo Ganini, Michele Antonucci, Marta Signoretti, Filomena Petta, Massimo Panei, Pierluigi Bove

Abstract

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.

Keywords: BPH; Benign prostatic hyperplasia; LUTS; Laser enucleation; ThuLEP; Urinary tract infections.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study CONSORT checklist (Available at ) www.consort-statement.org
Fig. 2
Fig. 2
Study flow-chart
Fig. 3
Fig. 3
2 × 2 tables reporting urine culture data across treatment groups at 15th and 30th postoperative day (POD). *After excluding asymptomatic bacteriuria
Fig. 4
Fig. 4
Box plot depicting the International Prostate Symptom Score (IPSS) in the groups (Group A—Mictalase® versus Group B—controls) at baseline, 15th and 30th postoperative day assessments

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