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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
206
Oral administration - 160 mg twice daily.
Oral administration - 0.4 mg daily.
Oral administration - twice daily.
Oral administration - daily.
Unnamed facility
Angers, France
Unnamed facility
Bordeaux, France
Unnamed facility
Cornebarrieu, France
Unnamed facility
Créteil, France
Unnamed facility
La Tronche, France
Unnamed facility
Le Fousseret, France
Unnamed facility
Limoges, France
Unnamed facility
Lyon, France
Unnamed facility
Marseille, France
Unnamed facility
Nice, France
...and 22 more locations
Change from baseline of Inflammation Biomarkers
"Inflammation biomarkers assay in patients suffering from Benign Prostatic Hyperplasia at Day 1, Day 30 and Day 90 : * Urine inflammation markers \[mRNA (messenger RiboNucleic Acid) and proteins\] on the first urine flow after digital rectal examination * Serum inflammation markers (C-Reactive Protein and Sedimentation Rate) "
Time frame: Day 1 (baseline), Day 30, Day 90
Change from baseline of urinary symptoms
Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)
Time frame: Day 1 (baseline), Day 30, Day 90
Change from baseline of quality of life
Impact of symptoms on quality of life on the basis of the I-PSS quality of life question scored by the patient
Time frame: Day 1 (baseline), Day 30, Day 90
Change from baseline of sexual activity
Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)
Time frame: Day 1 (baseline), Day 30, Day 90
Change from baseline of maximum urinary flow rate
Uroflowmetry performed using an electronic flow meter.
Time frame: Day 1 (baseline), Day 30, Day 90
Change from baseline of prostate volume
Prostate volume determined by transrectal ultrasound
Time frame: Day 1 (baseline), Day 30, Day 90
Change from baseline of post-void residual urine volume (PVR)
Post-void residual urine volume determined by suprapubic ultrasound.
Time frame: Day 1 (baseline), Day 30, Day 90
Number of adverse events
Number of adverse events
Time frame: up to 90 days
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