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Completed

NCT Number: NCT05130918

Efficacy of Mictalase® After ThuLEP

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.

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Key information

Conditions

BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Infections Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

San Carlo di Nancy Hospital

Roma, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Mictalase

Primary outcomes

  1. IPSS

    Time frame: 15 and 30 days post-operation

    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.

  2. QoL

    Time frame: 15 and 30 days post-operation

    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.

Secondary outcomes

  1. Urinary Infection

    Time frame: 15 and 30 days post-operation

    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.

Sponsors and collaborators

Lead sponsor

San Carlo di Nancy Hospital

Other

Collaborators

  • Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2021
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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