7° Congresso Nazionale

48
7° Congresso Nazionale Associazione Italiana di Endourologia
present time there is not enough critical data to support the
hypothesis that TUMT challenges TURP, further studies
that provide high quality of evidence are needed. Hoffman
et al (11) combined all evidence from randomized controlled
trials evaluating the efficacy and safety of microwave
thermotherapy in treating men with LUTS and BPH, in
order to quantify the therapeutic efficacy. Overall, 540
patients were randomized in the six eligible randomized
studies, including 322 to TUMT and 218 to TURP. Patients
included in the studies had moderate to severe LUTS, with
decreased Qmax and moderately enlarged prostates.
Studies generally excluded men with very large prostates
(>100 g), prominent median lobes and in urinary retention.
Treatment was offered by different TUMT devices and
software including Prostatron (Prostatsoft 2.0 and 2.5) and
ProstaLund Feedback. The mean (range) age was 67.8 (65-
70) years, baseline symptom score 19.5 (15.7-21.3), baseline
Qmax 8.6 (7.9-10.1) ml/sec and prostate volume 44.5
(33.9-52.7) ml, and did not differ by treatment group. Two
studies followed patients for 6 months and 4 studies provided
a 12-month follow-up. Five studies found significant
decreases in urinary symptoms and significant increases in
Qmax between baseline and follow-up for both TURP and
TUMT. Three studies (12-14) evaluated the effect of treatment
on QOL using the eight IPSS question. The pooled
mean QOL score for men undergoing TUMT decreased by
58.5% (4.1 to 1.7) and by 63.4% (4.1 to 1.2) in men
undergoing TURP. Although QOL significantly improved
after both TUMT and TURP, there were no significant differences
between treatments. Muttiasson et al (15,16) have
published the results of a prospective randomised study,
including 154 patients randomized to TUMT or TURP.
Total IPSS decreased 3 months after surgery from 21 to 8
(61.9%) in the TUMT group and from 20 to 7(65%) in the
TURP group, which was sustained over 5 years. Max flow
rate and IPSS QoL were comparable between the two
groups. In the TUMT group were observed few severe
complications (5%) and 10 % of patients needed additional
treatment. The burning question for thermal-based treatment
is how good the results remain in a long-term perspective.
Historically the Low-Energy TUMT has been
abandoned due to the disappointing durability of its
effects. Recent studies confirm the limited durability of
clinical outcome obtained by lower energy programs, with
a retreatment rate as high as 84.4% after 5-year follow-up
(17-19). In the randomized study with the longest available
follow-up by Floratos et al (12), the results of 36 month
follow-up were presented. Improvement in Qmax of the
TUMT group from 9.2 ml/sec retreatment to 15.1 ml/sec,
14.5 ml/sec and 11.9 ml/sec at 1-, 2 and 3 years, respectively,
was reported, whilst the IPSS symptom score
improved from 20 to 8, 9 and 12, respectively. These data
indicate that the level of improvement is durable up to 3
years. The retreatment rate for TUMT and TURP was
19.8% and 12.9%, respectively. It is important to underline
the different causes of retreatment. Retreatment was offered
to the TUMT patients because of primary treatment failure,
while in the TURP group, retreatment included reintervention
mainly because of urethral strictures, bladder neck
sclerosis, meatal stenosis, but rarely, treatment failure.
Similarly, Trock et al (20) performed a pooled analysis of 6
multicenter studies of cooled thermotherapy with compa-
Archivio Italiano di Urologia e Andrologia 2007, 79, 3, Supplemento 1
rable baseline measures. In total 541 patients were pooled
and data showed an improvement of 55%, 53% and 51%
in AUA symptom score, QOL and Qmax after TUMT,
respectively. A slight decrease was observed at 48 months
since subjective and objective improvement remained
durable (43%, 50% and 35%, respectively). One of the
commonly used arguments for the application of TUMT as
an alternative to TURP for BPH is its low morbidity. The
reported low morbidity and the absence of any need for
spinal or general anesthesia make TUMT a true outpatient
procedure, representing an excellent option for patients at
high operative risk (American Society of Anesthiologists
class 3 or 4) who are unsuitable for an invasive treatment.
TRANS-URETHRAL NEEDLE ABLATION (TUNA)
TUNA therapy uses low-level radiofrequency (RF) energy
that is delivered by needles into the prostate and that produces
localized necrotic lesions in the hyperplasic tissue.
The inner region of the prostate is selectively ablated with
temperatures approaching 90-100°C while the prostatic
urothelium is preserved (21,22). The TUNA system consists
of a special catheter attached to a generator. At the end
of the catheter there are two needles that are withdrawn
into two adjustable shields made from Teflon. The needles
are advanced into the prostatic tissue and can be placed
accurately into the required position. The generator produces
a monopolar RF signal of 490 kHz, which allows
excellent heat penetration and uniform tissue distribution
of heat (21,22). The advantage of TUNA is that it can be
delivered under topical anesthesia to patients with symptomatic
BPH and is an attempt to minimize operative risk
and reduce postoperative sequela and the need for a long
recovery period, while optimizing the therapeutic benefit.
There is a wide variety in the number of patients in each
series and in the length of follow-up. It can be noted that
most are open series, with a minority of randomized studies.
The size of studies varies from 10 to 188 patients, and,
in many cases, the number of patients, followed up for a
long period of time is less than 50% of the original sample,
which makes it difficult to draw definitive conclusions
(22). The results of 5 year follow-up of the United States
randomized clinical trial were presented (23). Following
treatment, significant improvement from baseline occurred
in symptom score, higher for TURP than for TUNA (statistically
significant in the first 4 years). The two groups
demonstrated a significant improvement in maximum urinary
flow rate (greater for TURP patients). TUNA showed
significantly fewer adverse events than TURP. The TURP
group reported 41% retrograde ejaculation, while the
TUNA group reported none. However, in the TUNA group
14% required further intervention with additional treatment
(TURP), against only 2% in the TURP cohort. The
results of this study demonstrate stable treatment outcomes
after 5 years of follow up and suggest that TUNA is an
attractive treatment option for men with LUTS due to BPH.
While the TURP improvement was superior, TUNA
showed lower adverse events (23). Another randomized
clinical trial comparing TUNA with TURP analyzed 59
patients (24). Improvements in Qmax, post voiding residual
volume (PVR), IPSS and the QOL score were statistically
significant for both groups at 3 and 18 months of fol-