Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation.

The aim of the study is to assess the activity on inflammation biomarkers (serum and urine inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the treatment of urinary symptoms related to BPH.

The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Permixon; Saw palmetto extract; Tamsulosin

Criteria

Inclusion Criteria:

• Male patient

• Between 45 and 85 years old.

• Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months

• I-PSS ≥ 10 at selection visit and ≥ 12 at randomisation visit (visit 2)

• Stable patient's disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2)

• I-PSS QoL score ≥ 3 evaluated at selection and randomisation visits,

• 5 mL/s ≤ maximum urinary flow rate < 15 mL/s for a voided volume ≥ 150 mL and ≤ 500 mL evaluated at randomisation visit (2 measurements if necessary)

• Prostatic volume ≥30 cm³ determined by transrectal ultrasound at randomisation visit (visit 2)

• Serum total PSA at randomisation visit (visit 2) :

• 4 ng/mL

• 10 ng/mL and Prostate Specific Antigen (free) / Prostate Specific Antigen (total) ≥ 25% or negative prostate biopsy within the past 6 months prior to selection visit.

• Patient able to understand and sign the informed consent and understand and fill in self-questionnaires

Exclusion Criteria:

• Post-void residual urine volume > 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2).

• Urological history :

• Urethral stricture disease and/or bladder neck disease

• Active (at selection and randomisation visits) or recent (< 3 months) or recurrent urinary tract infection

• Indication of BPH surgery

• Stone in bladder or urethra

• Acute or chronic (documented) prostatitis

• Prostate and cancer cancer treated or untreated

• Interstitial cystitis (documented by symptoms and/or biopsy)

• Active upper tract stone disease causing symptoms

• Patient with history of surgery of the prostate, bladder neck or pelvic region

• Any local and/or systemic inflammation disorders at selection and randomisation visit