Efficacy of Mictalase® After ThuLEP

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: Phenolmicin P3 and Bosexil suppository


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with symptomatic benign prostatic hyperplasia deemed eligible for thulium laser enucleation of prostate. Exclusion Criteria: patients with history of prostatitis, patients with history of neurogenic detrusor overactivity (as determined after urodynamic observation), patients diagnosed with prostate cancer, patients who underwent previous surgeries of the lower urinary tract, patients with indwelling catheter, patients with history of nephrolithiasis, patients with known or suspected hypersensitivity to Phenolmicin P3 and/or Bosexil patients experiencing occurrence of severe intraoperative complications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenolmicin P3 and Bosexil<br>Group in which patients were administered Phenolmicin P3 and Bosexil suppositories twice a day for 5 days, then once a day for other 10 days after thulium laser enucleation of prostate was performed. | Device: Phenolmicin P3 and Bosexil suppository<br>* 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.<br>* Other names: Mictalase;|
| No Intervention: Controls<br>Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS | evaluation of effects of the suppository on irritative symptoms as assessed by eventual reduction in International Prostate Symptom Score (IPSS). Specifically, % reduction in absolute value of IPSS will be compared between the groups. | 15 and 30 days post-operation | 
| QoL | evaluation of effects of the suppository on Quality of life as assessed by eventual reduction in Quality of Life score. Specifically, % reduction in absolute value of QoL will be compared between the groups. | 15 and 30 days post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Infection | evaluation of effects of the suppository on occurrence of urinary infections after thulium laser enucleation of prostate as assessed by urine culture. Specifically, the rates of positive urine culture will be compared between the groups. | 15 and 30 days post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign prostatic hyperplasia, BPH, laser enucleation, ThuLEP, LUTS, urinary tract infections