Transcript PROSTIVA RF Therapy - Clinical Evidence

Clinical Evidence
Outcomes
• Would you perform the PROSTIVA® RF
Therapy procedure on your father?
• Why do you think PROSTIVA RF Therapy
works?
PROSTIVA® RF Therapy Results
• Return to normal activities
within 48 hours
• Have few side effects
• Have low risk of sexual side
effects
• Long-term five year clinical
data shows the durability of
the procedure
PROSTIVA® RF Therapy
Long-term Durability
Can you speak to long-term durability?
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Hill B, Belville W, Bruskewitz R, Issa M, Perez-Marrero R, Roehrborn C,
Terris M, Naslund M, “Transurethral Needle Ablation versus Transurethral
Resection of the Prostate for the Treatment of Symptomatic Benign
Prostatic Hyperplasia: 5-Year Results of a Prospective, Randomized,
Multicenter Clinical Trial,” J Urol, 2004;171:2336-2340
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Zlotta, AR, Giannakopoulos X, Maehlum O, Ostrem T, Schulman CC, “LongTerm Evaluation of Transurethral Needle Ablation of the Prostate (TUNA) for
Treatment of Symptomatic Benign Prostatic Hyperplasia: Clinical Outcome
Up To Five Years From Three Centers,” Eur Urol, 2003; 44:89-93
•
Boyle P, Robertson C, Vaughan E D, Fitzpatrick J, “A Meta-Analysis of Trials
of Transurethral Needle Ablation for Treating Symptomatic Benign Prostatic
Hyperplasia”, British Journal of Urology Intl, 2004; 94: 83-88.
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AUA Guidelines 2004, “Management of Benign Prostatic Hyperplasia:
Diagnosis and Treatment Recommendations” Chapter 1, page 27.
Study Aim
Compare the long-term outcome following
RF therapy for BPH with that of TURP for
the treatment of LUTS secondary to BPH.
Six-month data from this study are reported
by Roehrborn et al, 1999, and 12-month
data by Bruskewitz et al, 1998.
Methodology
• Patients were randomized to RF therapy or TURP.
Following each procedure, patients were assessed at
12-month intervals for five years for the following
outcome measures: IPSS, QOL score, sexual function
questionnaire, Qmax, PVR, and adverse events.
• 121 men aged 50 years or over with LUTS secondary to
BPH for a minimum of three months duration were
recruited to the study. Inclusion criteria were:
– IPSS >13.0
– PFR ≤12 ml/sec; minimum voided volume ≥125 ml
– Prostate size 20-75 g
Results
• Statistically significant improvements in IPSS and Qmax and
improvement in the QOL score were reported in both study arms
from the first assessment at year one. These improvements
were maintained to year five.
• Although the improvement in IPSS achieved with TURP was
initially greater than that achieved with RF therapy, at five years
the mean IPSS in the two groups was the same (at least a 30%
improvement compared with baseline).
• The change in QOL with RF therapy and TURP was statistically
significant compared with baseline at each timepoint (at least a
30% improvement compared with baseline).
• A statistically significant reduction in PVR was observed in
TURP-treated patients throughout the study period, but not in the
RF therapy-treated patients.
Key Data
At five years’ follow-up, significantly fewer adverse events (p.< 0.0001)
were reported in patients treated with RF therapy than in those treated
with TURP. All patients treated with TURP were catheterized in the
immediate post-operative period compared with 40% of RF therapytreated patients. Indwelling catheter time for both groups was 24-48
hours.
Summary
• This study confirms the long-term durability of the efficacy of RF
therapy in reducing the symptoms associated with BPH. Other
outcomes of treatment, which were again maintained to five years,
were improvements in QOL and PFR.
• TURP is a more invasive procedure than RF therapy, involving the
removal of the majority of adenomatous tissue. It is to be expected,
therefore, that the improvement in Qmax in the TURP arm was
superior to that in the RF therapy arm.
• The greater improvement in the parameters assessed has to be
balanced against a higher rate of adverse events with TURP
compared with RF therapy.
• Failure rates were low and acceptable at five-year follow-up, with
more than 86% of patients not requiring additional therapy for BPH.
Nine (14%) RF therapy cases required further intervention for BPH
symptoms and underwent TURP.
Study Aim
Assess the long-term efficacy of RF therapy
in patients with symptomatic BPH.
Methodology
• Patients were treated with RF therapy in this
prospective, multicenter study. Following the procedure,
patients were assessed for IPSS, Qmax, QOL, serum
prostate-specific antigen (PSA), and prostate volume.
• 188 consecutive patients with symptomatic BPH from
three European centers (Belgium, Greece, and Norway)
were included in the study. Inclusion criteria were:
– Qmax < 15 ml/sec, > 5.0 ml/sec
– Prostate volume < 90 ml
– IPSS ≥ 18
– QOL ≥ 3
Results
• Long-term follow-up data were available for 131 patients
at four years and 121 patients at five years. Data were
analyzed together, as this was shown not to alter the
results significantly.
• At a mean follow-up of 63 months:
– IPSS decreased significantly from 20.9 to 8.7 (p < 0.001).
– Mean Qmax increased significantly from 8.6 ml/sec to 12/1
ml/sec (p < 0.01).
– PVR decreased significantly from 179 ml to 122 ml ( < 0.001).
• 41 (23.3%) out of 176 patients available for assessment
required additional therapy (medical therapy, retreatment
with RF therapy, surgery) at five years:
– 27 patients within the first three years
– 14 at four years
– zero at five years
Key Data
Percentage change from baseline in
IPSS, Qmax, and QOL score at a
mean of 63 months post-RF therapy.
Figures constructed using data from this paper.
Percentage of patients (n = 131)
achieving a 50% improvement over
baseline following RF therapy at longterm follow-up.
Summary
• This study provides evidence of the long-term clinical
improvement following RF therapy, with significant improvements
in IPSS, PFR, and PVR.
• Failure rates were low and acceptable at five years’ follow-up,
with more than 75% of patients not requiring additional therapy
for BPH.
• It can be concluded that RF therapy is an effective treatment for
symptomatic BPH, which can be easily performed under local
anesthesia.
• The protocol employed the first generation of RF therapy devices:
the TUNA II and TUNA III catheters. The procedure was
conducted under local anesthetic using 2% lidocaine applied
intraurethrally, on an inpatient basis. No suprapubic catheters
were placed after treatment.
Study Aim
Perform a meta-analysis on the short and
long-term efficacy of RF therapy for BPH.
Methodology
• Data collated from 14 studies and a meta-analysis conducted:
– two randomized studies, two non-randomized observational
protocols, and 10 single-arm studies.
• All patients included in the meta-analysis had severe LUTS
and a mean IPSS ≥ 20 before therapy.
• The meta-analysis was based on the change in mean IPSS
and Qmax values at the end of the study compared with
baseline.
• The estimation of the effects from the meta-analysis used a
multilevel model including random effects for the studies.
• Overall, there were 1244 patients with IPSS scores that could
be evaluated and 1331 with Qmax estimates.
Results
• The effect of RF therapy was to reduce the mean IPSS
by 50% at one year.
• Although there was a slight trend for IPSS to increase in
all arms from one to five years, the 50% decrease was
maintained at five years.
• Qmax increased by 70% at one year. Again, there was a
slight trend for Qmax to decrease with time, but the
improvement was still > 50% at five years compared with
baseline.
Key Data
RF therapy reduced the mean IPSS by 50% at one year and
was maintained to five years. Mean values shown. Figure
constructed using data from this paper.
Key Data
RF therapy increased Qmax by 70% at one year and was
maintained to five years. Mean values shown. Figure
constructed using data from this paper.
Conclusions
• This meta-analysis on 1244 patients confirms that RF
therapy for BPH is an effective therapy for men with
symptomatic BPH, including those with severe
symptoms.
• Mean improvement in IPSS from baseline was 12.1
points and for Qmax, 5.1 ml/sec.
• Improvement in IPSS and Qmax was significant at one
year, and this improvement was maintained to five years.
• It can be concluded that RF therapy is an effective,
minimally invasive therapy that is an attractive alternative
to surgery and to long-term medical therapy.
AUA Guidelines
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Definitions and terminology
Methodology
Diagnostic evaluation of BPH
Initial management and treatment options
Treatment recommendations
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