Objectives of the study
The aim of the study is to investigate and compare the treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy vs placebo for BPH patients
Study center
The study will be coordinated by the research office of 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. The research office will also support the project (logistics, quality control, management, data acquisition, publications).
Patients visits will be carried out in the BPH Research Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece.
Laboratory tests of all patients will be performed at the same microbiology laboratory.
Study population A total of 100 patients (50 in Group A and 50 in Group B) with BPH diagnosis will participate in this study.
Study design Double-blind placebo-controlled randomized clinical trial
Zero hypothesis (H0) and alternative hypothesis (H1):
(H0): Group A demonstrates similar efficacy compared to Group B for the treatment of BPH patients.
(H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment of BPH patients.
Study endpoints Primary endpoint: The difference between the Group A and Group B in the change of IPSS score from baseline to 12 weeks after treatment initiation.
Secondary endpoints:
* Adverse events rate in all patients during study period. * The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation. * The difference between the Group A and Group B in the change of the following parameters from baseline to 6 and 12 weeks after treatment initiation
1. Qmax value 2. Prostate volume 3. Post void residual 4. IIEF-ED score 5. Psa value 6. TNFa, IL 6 values
Treatment Visits :
Patients accordingly to which group they will be randomized will receive:
* Active treatment (Ralivia) Group : 1 pill of Ralivia per os/day for a 3-month period * Placebo Group : 1 placebo pill per os/day for a 3-month period
Adverse events will be reported.
FU Visit 1: 6 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported.
PSA TNFa, IL 1β, IL 6, IL 10 will be measured through blood test.
FU Visit 2: 12 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported.
DRE will be performed . PSA TNFa, IL 6 will be measured through blood test.
Participant must be between 50 and 80 years old.
Participant has signed and dated the appropriate Informed Consent document.
International Prostate Symptom Score (IPSS) ≥8 and ≤30
Prostate volume ≥30gram and ≤80gram
Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention.
Participant has a history of prostate, bladder or urethral cancer.
Participant has undergone pelvic radiation or systemic chemotherapy.
Participant has undergone intravesical chemotherapy.