Clinical trial NCT01604811: 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)
Official title: Exploratory Study of L.S.E.S.r. (PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in the Treatment of Urinary Symptoms Related to BPH; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2012-05-24
Enrollment: 206
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline of Inflammation Biomarkers
timeFrame: Day 1 (baseline), Day 30, Day 90
Secondary outcomes:
measure: Change from baseline of urinary symptoms
timeFrame: Day 1 (baseline), Day 30, Day 90
measure: Change from baseline of quality of life
timeFrame: Day 1 (baseline), Day 30, Day 90
measure: Change from baseline of sexual activity
timeFrame: Day 1 (baseline), Day 30, Day 90
measure: Change from baseline of maximum urinary flow rate
timeFrame: Day 1 (baseline), Day 30, Day 90
measure: Change from baseline of prostate volume
timeFrame: Day 1 (baseline), Day 30, Day 90
measure: Change from baseline of post-void residual urine volume (PVR)
timeFrame: Day 1 (baseline), Day 30, Day 90
measure: Number of adverse events
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Angers
country: France
city: Bordeaux
country: France
city: Cornebarrieu
country: France
city: Creteil
country: France
city: La Tronche
country: France
city: Le Fousseret
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Nice
country: France
city: Paris
country: France
city: Saint Orens de Gameville
country: France
city: Segre
country: France
city: Seysses
country: France
city: Tierce
country: France
city: Toulouse
country: France
city: Bari
country: Italy
city: Catanzaro
country: Italy
city: Firenze
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Perugia
country: Italy
city: Pisa
country: Italy
city: Trieste
country: Italy
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: A.Coruna
country: Spain
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Madrid
country: Spain
city: Sabadell
country: Spain
city: Sevilla
country: Spain
Study officials:
References: