Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy With Outflow Obstruction
Conditions
Keywords
LUTS, Iresine celosia, Odyliresin, medical therapy
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOdyliresin
Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)
DRUGAlfuzosin
10Mg Oral Tablet, Extended Release
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Average flow rate | 12 months |
| Adenoma volume | 12 months |
| Maximum flow rate | 12 months |
| adverse events | 12 months |
| Quality of life score | 12 months |
| Residual urine volume | 12 months |
Countries
Italy
Outcome results
None listed