NCT05130918

Efficacy of Mictalase® After ThuLEP

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: San Carlo di Nancy Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DEVICE	Phenolmicin P3 and Bosexil suppository	The suppository we herein investigated includes different active principles, namely: Bosexil®, that is a vegetal extract derived from the resin of the Boswellia serrata, a plant native to India. It has already been published that the Boswellic acids contained show anti-inflammatory and antioxidant properties in a variety of inflammatory diseases whose physio-pathological pathways are shared with those of prostatitis; phenolmicin P3 is a polyphenolic extract derived from beehive propolis, that also demonstrated anti-inflammatory and antioxidant properties in preclinical reports. It has also been reported to have the ability to create a microenvironment hostile to the reproduction of pathogenic bacteria.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-02-28
• Completion: 2021-04-30
• First posted: 2021-11-23
• Last updated: 2021-11-23

Locations

1 site across 1 country: Italy