BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Conditions
Keywords
benign prostatic hyperplasia, BPH, laser enucleation, ThuLEP, LUTS, urinary tract infections
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.
Interventions
DEVICEPhenolmicin 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.
Sponsors
Lampugnani Farmaceutici S.p.A. (Nerviano, Milan, Italy)
San Carlo di Nancy Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPSS | 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. |
| QoL | 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
| Measure | Time frame | Description |
|---|---|---|
| Urinary Infection | 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. |
Countries
Italy
Outcome results
None listed