An interventional study of Phenolmicin P3 and Bosexil suppository in BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms, sponsored by San Carlo di Nancy Hospital. Completed at 1 site in Italy. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by San Carlo di Nancy Hospital · Not applicable, Interventional, and Treatment
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.
406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's enrollment of 111 is above the median of 93 across 260 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →San Carlo di Nancy Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Group in which patients were not administered Phenolmicin P3 and Bosexil suppositories after thulium laser enucleation of prostate was performed.
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
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.
Time frame: 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.
Time frame: 15 and 30 days post-operation
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.
Time frame: 15 and 30 days post-operation
Plan to share: No — The analysis of the data obtained within the trial will be subject of scientific publication
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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San Carlo di Nancy Hospital