Clinical Studies; Study Design - Medtronic Prostiva 8930 Guía Para El Usuario

8930EN_5.fm 12/17/10 2:44 pm
UCxxxxxx EN
7 x 9 inches (178 mm x 229 mm)

Clinical Studies

Study Design

MA07445A008 Rev X
Additional warnings and precautions applicable to specific
procedures can be found at appropriate places in this system user
guide.
Clinical studies using the TUNA Procedure were performed at
multiple medical institutions throughout the United States.
Patients with lower urinary tract symptoms secondary to benign
prostatic hyperplasia (BPH) were enrolled in separate clinical
studies to determine the safety and efficacy of the TUNA Therapy.
One clinical study included a multicenter, single blind, randomized
study comparing the TUNA Therapy to TURP (Transurethral
Resection of the Prostate). Of the 167 patients treated in the
study, 111 were treated with the TUNA Therapy and 56 were
treated with TURP. Safety was measured by the rate and severity
of adverse events. Efficacy was evaluated by measuring
peak-flow rate and AUA (American Urological Association)
symptom score.
Patients 45 years or older with lower urinary tract symptoms
secondary to the diagnosis of BPH who have both lateral and
median lobe involvement were enrolled in additional two studies
(PM1 and P01) to determine safety and efficacy.
The prostate glands were between 30 to 100 grams. Of the 50
patients treated in the studies, 45 were followed up for six months
and 24 had up to one-year follow-up data.
TUNA Therapy Clinical Overview
2010-12 8930 System User Guide English
Medtronic Confidential
CRMRef_R06
89
Overview