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) (PERMIN)

Pierre Fabre

Status and phase

Completed

Phase 4

Conditions

Benign Prostatic Hyperplasia (BPH)

Treatments

Drug: Tamsulosine Arrow LP

Drug: Permixon® 160 mg

Drug: Placebo matching Permixon® 160 mg

Drug: Placebo matching Tamsulosine Arrow LP

Study type

Interventional

Funder types

Industry

Identifiers

NCT01604811

P00048 GP 4 03

2011-005307-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

206 patients

Sex

Male

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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