Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia

Not Applicable

Completed

• Conditions: Benign Prostatic Hypertrophy With Outflow Obstruction; Benign Prostatic Hyperplasia
• Interventions: Dietary Supplement: Odyliresin; Drug: Alfuzosin

• Registration Number: NCT02977832
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-11-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-26
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
odyliresin	Odyliresin	Odyliresin (Iresine celosia) 2 ml
alphalytic	Odyliresin	alpha-antagonist (alfuzosin 10 mg)
odyliresin	Alfuzosin	Odyliresin (Iresine celosia) 2 ml
alphalytic	Alfuzosin	alpha-antagonist (alfuzosin 10 mg)

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score	12 months

Secondary Outcome Measures

Name	Time	Method
Maximum flow rate	12 months
Residual urine volume	12 months
Average flow rate	12 months
Adenoma volume	12 months
adverse events	12 months
Quality of life score	12 months

Trial Locations

Locations (1)

Urology Department Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy