Serenoa repens, lycopene and selenium vs. tamsulosin for the treatment of lower urinary tract symptoms (LUTS)/ Benign prostatic hyperplasia (BPH)

Not Applicable

Completed

• Conditions: Benign prostatic hyperplasia (BPH) / lower urinary tract symptoms (LUTS); Urological and Genital Diseases; Benign prostatic hyperplasia (BPH)

• Registration Number: ISRCTN78639965
• Lead Sponsor: Konpharma (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-11
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 225

Inclusion Criteria

1. Age between 55 and 80 years old
2. Digital rectal examination negative for prostate cancer
3. Prostate-specific antigen (PSA) = 4 ng / ml, International Prostate Symptom Score (IPSS) = 12, prostate volume = 60 cc (assessed by suprapubic ultrasound), Qmax = 15 ml / s, post -void residual urine <150 ml.

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.Anti-androgens, 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 5-ARI or surgical treatment for LUTS/BPH
3. Patients with catheter or with an episode of acute retention of urine in the last 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified