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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02977832
• Date of registration: 28/11/2016
• Prospective Registration: No
• Primary sponsor: IRCCS Policlinico S. Matteo
• Public title: Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia Odyliresin
• Scientific title: A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
• Date of first enrolment: January 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02977832
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy

Contacts

• Name: Carmine Tinelli, MD
• Affiliation: Ethics Committee

Key inclusion & exclusion 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



Age minimum: 45 Years
Age maximum: 80 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Benign Prostatic Hyperplasia

Benign Prostatic Hypertrophy With Outflow Obstruction

Intervention(s)

Drug: Alfuzosin

Dietary Supplement: Odyliresin

Primary Outcome(s)

International Prostate Symptom Score [Time Frame: 12 months]

Secondary Outcome(s)

Adenoma volume [Time Frame: 12 months]

Average flow rate [Time Frame: 12 months]

Residual urine volume [Time Frame: 12 months]

adverse events [Time Frame: 12 months]

Quality of life score [Time Frame: 12 months]

Maximum flow rate [Time Frame: 12 months]

Secondary ID(s)

IRCCSPSM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors