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NCT Number: 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)

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.

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Permixon® 160 mg

Drug

Oral administration - 160 mg twice daily.

Tamsulosine Arrow LP

Drug

Oral administration - 0.4 mg daily.

Placebo matching Permixon® 160 mg

Drug

Oral administration - twice daily.

Placebo matching Tamsulosine Arrow LP

Drug

Oral administration - daily.

Primary outcomes

  1. Change from baseline of Inflammation Biomarkers

    Time frame: Day 1 (baseline), Day 30, Day 90

    "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) "

Secondary outcomes

  1. Change from baseline of urinary symptoms

    Time frame: Day 1 (baseline), Day 30, Day 90

    Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)

  2. Change from baseline of quality of life

    Time frame: Day 1 (baseline), Day 30, Day 90

    Impact of symptoms on quality of life on the basis of the I-PSS quality of life question scored by the patient

  3. Change from baseline of sexual activity

    Time frame: Day 1 (baseline), Day 30, Day 90

    Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)

  4. Change from baseline of maximum urinary flow rate

    Time frame: Day 1 (baseline), Day 30, Day 90

    Uroflowmetry performed using an electronic flow meter.

  5. Change from baseline of prostate volume

    Time frame: Day 1 (baseline), Day 30, Day 90

    Prostate volume determined by transrectal ultrasound

  6. Change from baseline of post-void residual urine volume (PVR)

    Time frame: Day 1 (baseline), Day 30, Day 90

    Post-void residual urine volume determined by suprapubic ultrasound.

  7. Number of adverse events

    Time frame: up to 90 days

    Number of adverse events

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study 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

Acronym: PERMIN

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 24, 2012
Registry last updated
Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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