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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130918
• Other study ID #: Mictalase
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: November 2021
• Source: San Carlo di Nancy Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	San Carlo di Nancy Hospital	Roma

Sponsors (2)

Lead Sponsor	Collaborator
San Carlo di Nancy Hospital	Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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