Benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) Urological and Genital Diseases Hyperplasia of prostate
Conditions
Interventions
1. Group A Serenoa repens 320mg, selenium and lycopene (Profluss ®) 1 tablet per day for 6 months.
2. Group B Tadalafil® 5mg 1 tablet a day for 6 months
Sponsors
Konpharma SRL
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age between 50 and 75 2. Digital rectal examination negative for prostate cancer 3. Prostate specific antigen (PSA) <4ng/ml 4. IPSS =12 5. PVR <100 ml 6. Peak flow between 4 and 15ml/s
Exclusion criteria
Exclusion criteria: 1. Prostate cancer, previous bladder cancer, diabetes mellitus, neurogenic disorders, severe liver disease, history of orthostatic hypotension or syncope, symptomatic urinary tract infection. 2. Antiandrogens, antidepressants (neuroleptics, anticholinergics) therapy, recent treatment with an a blocker (within 1 month) or phytotherapy including saw palmetto extract (within 3 months), previous medical therapy with 5ARI, PDE-5i or surgical treatment for LUTS/BPH. 3. Patients with catheter or with an episode of acute retention of urine in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change of international prostate symptom score (IPSS) and peak flow in patients treated with Profluss® or Tadalafil® 5mg. The study is designed as non-inferiority study with a 95% power and an equivalence margin of 0.5 for IPSS and of 0.8 for the peak flow. 2. IPSS quality of life (QoL) questionnaire 3. Maximum urinary flow rate (Qmax uroflowmetry) 4. International Index of Erectile Function (IIEF-5) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean changes of post-void residual (PVR) volume in patients treated with Profluss® or Tadalafil® 5 mg at enrollment (visit 0), one month (visit 1), at 3 months (visit 2), at 6 months (visit 3) | — |
Countries
Italy
Contacts
Public ContactGiorgio Ivan Russo
Outcome results
None listed