Back to resultsEfficacy of Mictalase® After ThuLEP
Primary Purpose
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Phenolmicin P3 and Bosexil suppository
Sponsored by
About this trial
This is an interventional treatment trial for BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms focused on measuring benign prostatic hyperplasia, BPH, laser enucleation, ThuLEP, LUTS, urinary tract infections
Eligibility Criteria
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.
Sites / Locations
- San Carlo di Nancy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Phenolmicin P3 and Bosexil
Controls
Arm Description
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.
Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05130918
First Posted
November 2, 2021
Last Updated
November 11, 2021
Sponsor
San Carlo di Nancy Hospital
Collaborators
Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)
1. Study Identification
Unique Protocol Identification Number
NCT05130918
Brief Title
Efficacy of Mictalase® After ThuLEP
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
San Carlo di Nancy Hospital
Collaborators
Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Keywords
benign prostatic hyperplasia, BPH, laser enucleation, ThuLEP, LUTS, urinary tract infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phenolmicin P3 and Bosexil
Arm Type
Experimental
Arm Description
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.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed.
Intervention Type
Device
Intervention Name(s)
Phenolmicin P3 and Bosexil suppository
Other Intervention Name(s)
Mictalase
Intervention Description
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.
Primary Outcome Measure Information:
Title
IPSS
Description
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.
Time Frame
15 and 30 days post-operation
Title
QoL
Description
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.
Time Frame
15 and 30 days post-operation
Secondary Outcome Measure Information:
Title
Urinary Infection
Description
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.
Time Frame
15 and 30 days post-operation
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
The trial is conducted on a population of males who underwent surgical intervention for benign prostatic hyperplasia.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierluigi Bove, MD
Organizational Affiliation
San Carlo di Nancy Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Carlo di Nancy Hospital
City
Roma
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The analysis of the data obtained within the trial will be subject of scientific publication
Citations:
PubMed Identifier
35151280
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy of Mictalase® After ThuLEP
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