Efficacy of Mictalase® After ThuLEP

NCT05130918 | Completed DMC

• 1 other identifier: Mictalase
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

benign prostatic hyperplasia; BPH; laser enucleation; ThuLEP; LUTS; urinary tract infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Urinary Infection

  15 and 30 days post-operation

Study Arms (2)

Phenolmicin P3 and Bosexil

EXPERIMENTAL

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

Controls

NO INTERVENTION

Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed.

Interventions

Phenolmicin P3 and Bosexil suppository DEVICE

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.

Also known as: Mictalase

Phenolmicin P3 and Bosexil

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: The trial is conducted on a population of males who underwent surgical intervention for benign prostatic hyperplasia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with symptomatic benign prostatic hyperplasia deemed eligible for thulium laser enucleation of prostate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Carlo di Nancy Hospital: lead
• Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy): collaborator

Study Sites (1)

San Carlo di Nancy Hospital

Roma, Italy

Location

Related Publications (1)

• Bertolo R, Cipriani C, Vittori M, Carilli M, Maiorino F, Iacovelli V, Ganini C, Antonucci M, Signoretti M, Petta F, Panei M, Bove P. The efficacy of a suppository based on Phenolmicin P3 and Bosexil (Mictalase(R)) in control of irritative symptoms in patients undergoing thulium laser enucleation of prostate: a single-center, randomized, controlled, open label, phase III study. BMC Urol. 2022 Feb 12;22(1):19. doi: 10.1186/s12894-022-00974-0.

  PMID: 35151280 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Pierluigi Bove, MD

  San Carlo di Nancy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 23, 2021
• Study Start: December 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: April 30, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)