Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2019-12-01
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phenolmicin P3 and Bosexil
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.
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.
Controls
Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
99 Years
MALE
No
Sponsors
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Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)
UNKNOWN
San Carlo di Nancy Hospital
OTHER
Responsible Party
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Principal Investigators
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Pierluigi Bove, MD
Role: PRINCIPAL_INVESTIGATOR
San Carlo di Nancy Hospital
Locations
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San Carlo di Nancy Hospital
Roma, , Italy
Countries
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References
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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.
Other Identifiers
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Mictalase
Identifier Type: -
Identifier Source: org_study_id