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

Primary Purpose

Benign Prostatic Hypertrophy With Outflow Obstruction, Benign Prostatic Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Odyliresin
Alfuzosin
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hypertrophy With Outflow Obstruction focused on measuring LUTS, Iresine celosia, Odyliresin, medical therapy

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urology Department Fondazione IRCCS Policlinico San Matteo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

odyliresin

alphalytic

Arm Description

Odyliresin (Iresine celosia) 2 ml

alpha-antagonist (alfuzosin 10 mg)

Outcomes

Primary Outcome Measures

International Prostate Symptom Score

Secondary Outcome Measures

Maximum flow rate
Average flow rate
Adenoma volume
Residual urine volume
adverse events
Quality of life score

Full Information

First Posted
November 28, 2016
Last Updated
February 26, 2017
Sponsor
IRCCS Policlinico S. Matteo
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1. Study Identification

Unique Protocol Identification Number
NCT02977832
Brief Title
Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Acronym
Odyliresin
Official Title
A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy With Outflow Obstruction, Benign Prostatic Hyperplasia
Keywords
LUTS, Iresine celosia, Odyliresin, medical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
odyliresin
Arm Type
Experimental
Arm Description
Odyliresin (Iresine celosia) 2 ml
Arm Title
alphalytic
Arm Type
Experimental
Arm Description
alpha-antagonist (alfuzosin 10 mg)
Intervention Type
Dietary Supplement
Intervention Name(s)
Odyliresin
Other Intervention Name(s)
Iresine Celosia
Intervention Description
Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Other Intervention Name(s)
alphalytic
Intervention Description
10Mg Oral Tablet, Extended Release
Primary Outcome Measure Information:
Title
International Prostate Symptom Score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Maximum flow rate
Time Frame
12 months
Title
Average flow rate
Time Frame
12 months
Title
Adenoma volume
Time Frame
12 months
Title
Residual urine volume
Time Frame
12 months
Title
adverse events
Time Frame
12 months
Title
Quality of life score
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmine Tinelli, MD
Organizational Affiliation
Ethics Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Urology Department Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18533373
Citation
Edwards JL. Diagnosis and management of benign prostatic hyperplasia. Am Fam Physician. 2008 May 15;77(10):1403-10.
Results Reference
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Learn more about this trial

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

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