Efficacy of Mictalase® After ThuLEP

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms Clinical Trial

Official title: The Efficacy of a Suppository Based on Phenolmicin P3 and Bosexil in Control of Irritative Symptoms in Patients Undergoing Thulium Laser Enucleation of Prostate: a Single-center, Randomized, Controlled, Open Label, Phase III Study

Status Completed

Clinical Trial Summary

In this single-center, prospective, randomized, open label, phase-III study, patients with indication to Thulium Laser Enucleation of Prostate were enrolled. The report conformed to CONSORT 2010 guidelines. Eligible patients were 1:1 randomized. Randomization defined Group A: patients who were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days; Group B: patients who did not receive the suppositories ("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 International Prostate Symptom Score (IPSS) with Quality of Life (QoL) questionnaire. Secondary endpoint included evaluation of effects on urinary tract infections by performance of urinalysis with urine culture.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
• Lower Urinary Tract Symptoms

• NCT number: NCT05130918
• Study type: Interventional
• Source: San Carlo di Nancy Hospital
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Completion date: April 30, 2021