Clinical Evidence

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Clinical Evidence
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Outcomes

• Would you perform the PROSTIVA RF Therapy
  procedure on your father?
• Why do you think PROSTIVA RF Therapy works?

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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

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PROSTIVA RF Therapy Long-term Durability

• Can you speak to long-term durability?
• 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,
  20041712336-2340
• Zlotta, AR, Giannakopoulos X, Maehlum O, Ostrem
  T, Schulman CC, Long-Term 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
  4489-93
• 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.
• AUA Guidelines 2004, Management of Benign
  Prostatic Hyperplasia Diagnosis and Treatment
  Recommendations Chapter 1, page 27.

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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.

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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 gt13.0
• PFR 12 ml/sec minimum voided volume 125 ml
• Prostate size 20-75 g

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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.

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Key Data
At five years follow-up, significantly fewer
adverse events (p.lt 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
therapy-treated patients. Indwelling catheter
time for both groups was 24-48 hours.
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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.

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Study Aim

• Assess the long-term efficacy of RF therapy in
  patients with symptomatic BPH.

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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 lt 15 ml/sec, gt 5.0 ml/sec
• Prostate volume lt 90 ml
• IPSS 18
• QOL 3

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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
  lt 0.001).
• Mean Qmax increased significantly from 8.6 ml/sec
  to 12/1 ml/sec (p lt 0.01).
• PVR decreased significantly from 179 ml to 122 ml
  ( lt 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

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Key Data
Percentage change from baseline in IPSS, Qmax,
and QOL score at a mean of 63 months post-RF
therapy.
Percentage of patients (n 131) achieving a 50
improvement over baseline following RF therapy at
long-term follow-up.
Figures constructed using data from this paper.
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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.

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Study Aim

• Perform a meta-analysis on the short and
  long-term efficacy of RF therapy for BPH.

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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.

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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 gt 50 at five
  years compared with baseline.

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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.
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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.

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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.

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AUA Guidelines

• Definitions and terminology
• Methodology
• Diagnostic evaluation of BPH
• Initial management and treatment options
• Treatment recommendations

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• For more information about PROSTIVA RF Therapy,
  call [phone], x6000 or visit
  www.prostiva.com
• CAUTION Federal law (USA) restricts this device
  to sale by or on the order of a physician.