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.

Inclusion Criteria:

1. Participant must be between 50 and 80 years old.
2. Participant has signed and dated the appropriate Informed Consent document.
3. International Prostate Symptom Score (IPSS) ≥8 and ≤30
4. Prostate volume ≥30gram and ≤80gram
5. Peak urinary flow rate (Qmax) ≥5 ml/sec and ≤15ml/sec
6. Post void residual volume ≤150ml

Exclusion Criteria:

1. Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention.
2. Participant has a history of prostate, bladder or urethral cancer.
3. Participant has undergone pelvic radiation or systemic chemotherapy.
4. Participant has undergone intravesical chemotherapy.
5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition (except from BPH) associated with LUTS, any neurological disease or disorder affecting the bladder.
6. Participant has undergone prostate surgery
7. Participant with penile or urinary sphincter implants.
8. Diagnosed neurological conditions known to affect bladder function (e.g., multiple sclerosis, Parkinson's disease, or neurogenic bladder).
9. Significant medical conditions (e.g., unstable cardiac arrhythmias, uncontrolled diabetes, severe renal impairment) that pose an unreasonable risk to the patient or might interfere with study results.
10. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.
11. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.