Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action
 on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume,
 improving the patient's quality of life and eventually limiting the number of patients who
 require surgery or endoscopy after medical treatment.
The aim of this phase II open clinical trial was to determine if Odyliresin, given its unique
 chemical structure, has a therapeutic effect on BPH-related LUTS, so as to reduce symptoms,
 prostate volume, improve the patient's quality of life and eventually to limit number of
 patients who require surgery or endoscopy after medical treatment. To this aim, patients who
 seek specialist advice for LUTS with no previous surgical treatment for BPH have been
 selected for treatment with Odyliresin in addition to an alpha-antagonist, in order determine
 whether at 12 months a clinical result is obtained, if after 6 and 12 months BPH symptoms are
 significantly improved, and a reduction of prostatic volume can be observed, thus changing
 the usual course of the disease. All patients with BPH-related LUTS received both alphalitic
 and Odyliresin treatment, clinical parameters and uroflowmetry parameters significantly
 improved, adenoma volume and post-void residual volume were significantly reduced at 12
 month. This is the first clinical experience with Iresine Celosia in BPH.
Inclusion Criteria:

 -  45 years of age or older

 -  Clinically diagnosed with mild to moderate BPH

 -  Prostatic volume ≥ 30 ml determined by transrectal ultrasound

 -  Maximum flow rate (Qmax) < 15 ml/sec for a voided volume 150-500 ml

 Exclusion Criteria:

 -  Participants must not have severe BPH (IPSS symptom score >21)

 -  Participants should not be currently undergoing any other form of medical therapy for
 BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E,
 and quercetin).

 -  Patients must not have undergone prior transurethral resection of the prostate (TURP).

 -  Post void residual (PVD) > 200 ml

 -  Previous urological history including urethral stricture disease and/or bladder neck
 disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer,
 interstitial cystitis, active upper tract stone disease causing symptoms,
 insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes
 mellitus, chronic renal failure