Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia (NCT02977832) | Clinical Trial Compass
CompletedNot Applicable
Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Italy30 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range45 Years – 80 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
International Prostate Symptom Score
Timeframe: 12 months
Trial details
NCT IDNCT02977832
SponsorFondazione IRCCS Policlinico San Matteo di Pavia