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

Serenoa repens, lycopene and selenium vs. tamsulosin for the treatment of (LUTS)/ (BPH): An Italian multicenter comparative randomized study between single or combination therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78639965

Enrollment

225

Registered

2013-12-11

Start date

2011-03-01

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Participants were randomized with a 1:1:1 ratio into three treatment arms each consisting of 75 patients: group A (Ser 320 mg, Ly and Se ( Profluss ®) 1 tablet per day for 1 year), group B (tamsulosin

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Reduction of IPSS (= 3 points from baseline), a percentage reduction of IPSS (IPSS%) = 25%, increase of Qmax (= 30% from the baseline) and the reduction of PVR in patients treated with SeR, Ly and Se (Profluss ®) + tamsulosin compared to those treated with SeR, Ly and Se (Profluss®) or tamsulosin monotherapies after 1 year	—

Secondary

Measure	Time frame
Secondary endpoints of the study were considered the change in erectile function (assessed by the International Index of Erectile Function-5 questionnaire), prostate volume, serum PSA and QoL at 1 year	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 19, 2026