Efficacy Data - Medtronic Prostiva 8930 Guía Para El Usuario

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Efficacy Data

Table 5-2. Efficacy Data of the TUNA Therapy vs. TURP Study
Parameter
AUA Symptom
TUNA Therapy
TURP
Peak Flow Rate
TUNA Therapy
TURP
Post-Void Residual
Value
TUNA Therapy
TURP
Quality of Life
TUNA Therapy
TURP
MA07445A008 Rev X
The original prospective clinical trial (lateral lobe only) was
performed at eight (8) medical centers across the United States.
One hundred sixty-seven (167) men 50 years of age or older with
symptomatic BPH were enrolled in this original trial. One hundred
twenty-one (121) of these patients were randomized to either the
TUNA Therapy or TURP: sixty-five (65) were treated with the
TUNA Therapy and fifty-six (56) underwent TURP. Forty-six (46)
additional non-randomized patients were treated with TUNA,
making the total TUNA-treated population one hundred eleven
(111).
Mean values for AUA (American Urological Association)
Symptom Score, Peak Flow Rate, Post Void Residual Volume,
and Quality of Life (QOL) score between the TUNA Therapy and
TURP groups were measured at baseline, 6 months, and 12
months following the treatment, respectively (Table 5-2).
Baseline
23.8
24.1
8.9
8.9
91.4
81.9
4.7
4.8
TUNA Therapy Clinical Overview
6 Months 12 Months
10.6 11.9
7.9 7.8
13.4 14.8
21.0 21.1
63.6 65.9
45.6 47.1
1.9 1.9
1.6 1.4
2010-12 8930 System User Guide English
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