Clinical trial NCT02977832: Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Official title: A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hypertrophy With Outflow Obstruction
Benign Prostatic Hyperplasia
Keywords: LUTS
Iresine celosia
Odyliresin
medical therapy
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: International Prostate Symptom Score
timeFrame: 12 months
Secondary outcomes:
measure: Maximum flow rate
timeFrame: 12 months
measure: Average flow rate
timeFrame: 12 months
measure: Adenoma volume
timeFrame: 12 months
measure: Residual urine volume
timeFrame: 12 months
measure: adverse events
timeFrame: 12 months
measure: Quality of life score
timeFrame: 12 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Urology Department Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Ethics Committee
name: Carmine Tinelli, MD
role: STUDY_CHAIR
References:
citation: Edwards JL. Diagnosis and management of benign prostatic hyperplasia. Am Fam Physician. 2008 May 15;77(10):1403-10.