Mild/moderate benign prostatic hypertrophy (BPH) Urological and Genital Diseases Hyperplasia of prostate
Conditions
Interventions
The randomization sequence will be generated by a statistician using STATA 16 software (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC), and participants (compliant to the
PSA, neutrophil/lymphocyte ratio (N/L) derived from blood tests analysed by Unisannio Lab (San Giorgio del Sannio, BN, Italy)
urinations number during the night before the clinical visit, and IPSS score are registered.
In detail, the specific analyses are shown below:
t0: Ecovol, PVR (Ecormp)
Sponsors
EPO Srl
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged over 45 2. No clinically significant deviation in laboratory tests 3. History of mild BPH for at least 1 year 4. Pharmacologically treated but not controlled BPH 5. IPSS score = 8 and = 19 (moderate symptoms) 6. Prostate volume = 25cc and = 70cc 7. PVR between 30 ml and 200 ml 8. PSA = 4 ng/ml
Exclusion criteria
Exclusion criteria: 1. Acute or chronic disease that could interfere with the study or dangerous for the participant 2. Use of any of the following concomitant drugs: immunosuppressants, anticoagulants, a-blockers, 5a-reductase inhibitors, antipsychotics, chemotherapy drugs, drugs for dementia, male hormone replacement therapy and drugs for overactive bladder, atonic and/or neurogenic bladder 3. Bladder neck contracture 4. Acute prostatitis; bladder calculosis: urinary tract infection more than once in the last 12 months 5. Prostate or bladder cancer; history of pelvic trauma or surgery; clinically significant kidney or hepatic insufficiency 6. Microscopic hematuria that was not evaluated by a urologist and not attributed to BPH 7. Any condition that might interfere with the subject's ability to give informed consent, to comply with study instructions, to provide an objective evaluation of his or her symptoms, or that might confuse the interpretation of study results 8. Those considered unsuitable for the participation by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-void residual volume (PVR or Ecormp) and prostate volume (and weight), both measured using prostatic ultrasound at baseline (t0) and after 5 months (t3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatology assessed at t0, t2, t3 using the following: 1. International Prostatic Symptoms Score (IPSS) 2. Number of urinations during the night before the clinical visit measured by a questionnaire 3. Neutrophil/lymphocyte ratio (N/L) measured by blood analysis 4. Prostate-specific antigen (PSA) measured by blood analysis | — |
Countries
Italy
Contacts
Public ContactCristina Esposito
Outcome results
None listed