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TUMT met ProstaLund Feedback Threatment®

1. Een betere controle van de temperatuur in de prostaat geeft een verbetering van de
2. De mate van doorbloeding is voor een belangrijk deel bepalend voor het resultaat van een TUMT- behandeling. Slechts door het continu meten van de temperatuur in de prostaat kan de variatie in doorbloeding worden gecompenseerd waardoor de resultaten consistenter worden. 3. De grote variatie in doorbloeding (zichtbaar gemaakt met PET-scans) toont aan dat het noodzakelijk is de temperatuur in de prostaat te monitoren om de resultaten te optimaliseren. 4. 5th Int. Consultation on BPH: TUMT is de enige 'alternatieve' techniek die het stadium van volwassenheid heeft bereikt. Tijdens TUMT is het essentieel de temperatuur in de prostaat te meten en te controleren. 5. Naast TUR-P heeft High Energy TUMT een sterke plaats verworven als minimaal invasieve modaliteit. Dit in tegenstelling tot verschillende andere technieken. 6. Validatie van de berekening (door het ProstaLund-apparaat) van de 'cell-kill' tijdens de 7. Uitleg over de werking van TUMT: temperatuur in de prostaat en de behandeltijd zijn bepalend voor de cell-kill. Individuele verschillen in doorbloeding kunnen worden gecompenseerd middels het vermogen (W) en de behandeltijd. 8. PLFT® vergeleken met TUR-P bij patiënten met retentie. PLFT® lijkt even effectief als TUR-P, 9. PLFT® vergeleken met TUR-P. 12 mnd resultaten. PLFT® lijkt even effectief als TUR-P, maar 10. EAU-richtlijn BPH 2001: TUMT is de meest aantrekkelijk niet-chirurgische techniek. 11. Ervaring van patiënten tijdens de behandeling. Zoals: allemaal urge; pijn: 46 mm (op VAS schaal van 0-100 mm) maar nooit reden om te stoppen. 12. Het vooraf toedienen van mepivacaine epinephrine in de prostaat (verminderd / stopt de doorbloeding). Hierdoor wordt de behandeltijd met 50% verkort en wordt het comfort voor patiënt aanzienlijk verhoogd. 13. PLFT® vergeleken met TUR-P. PLFT® lijkt even effectief als TUR-P, maar bij een TUR-P operatie wordt er relatief meer weefsel verwijderd. 14. Validatie van de berekening (door het ProstaLund-apparaat) van de 'cell-kill' tijdens de 15. Zelfde studie als nr.9. Nu met 24 mnd data. PLFT(r) lijkt nog steeds even effectief als TUR-P, 16. Studie in Nederland (Nijmegen, 2002), 33 patiënten, goede resultaten na 1 jaar. Geen vergelijking 17. PLFT® vergeleken met TUR-P. 12 mnd resultaten. PLFT® is even effectief als TURP, maar veiliger. Publicatie in 'Urology' aug. 2002 18. Behandeling van 18 patiënten met prostaatkanker.
1.
Intraprostatic temperature monitoring during transurethral microwave thermotherapy for the
treatment of benign prostatic hyperplasia.
Wagrell L, Schelin S, Bolmsjo M, Brudin L.
J Urol 1998 May;159(5):1583-7
Purpose: We evaluated whether the results of transurethral microwave thermotherapy improve using
high intraprostatic temperature of 55°C or greater.
Materials and Methods: We accrued 30 men 58 to 85 years old (mean age 69) from the waiting list for
transurethral prostatic resection in whom maximum urinary flow was less than 13 ml. per second and
Madsen score was greater than 8. According to the Abrams-Griffith nomogram all but 1 patient had
obstruction. Before treatment 3 thin temperature probes, each containing 5 sensors in a row, were
introduced into the prostate from the perineum and positioned using transurethral ultrasound
guidance. The microwave power of the transurethral microwave thermotherapy equipment was set
based on the actual temperature in the prostatic tissue. A temperature of at least 55°C and often more
than 60°C was reached at the hottest spot. Treatment duration was 1 hour. Postoperatively an
indwelling catheter remained in place for 2 weeks. Patients were followed for 6 months with the first
followup after 3 months.
Results: At the 3-month followup mean maximum urinary flow had increased from 7.4 to 12.5 ml. per
second and the mean Madsen score had decreased from 12.6 to 2.9. At the 6-month followup mean
maximum urinary flow was 12.2 ml. per second and the mean Madsen score was 3.4. Using pressure-
flow data we divided the patients into responders and nonresponders. In the 18 responders maximum
urinary flow had increased from 7.2 to 14.6 ml. per second (103%), the Madsen score had decreased
from 12.5 to 1.4 (89%) and detrusor pressure had decreased from 9.2 to 6 kPa. (35%).
Conclusions: High energy transurethral microwave thermotherapy relieved bladder outlet obstruction
in 60% of the patients and had a good effect on symptoms. Compared with a previous multicenter
study with 40% responders, using the same criteria there were 60% responders in our series. Our
results indicate that better control of intraprostatic temperature provides better results, approaching
those after transurethral prostatic resection.
2.
Optimizing transurethral microwave thermotherapy: a model for studying power, blood flow,
temperature variations and tissue destruction.
Bolmsjo M, Sturesson C, Wagrell L, Andersson-Engels S, Mattiasson A.Br
J Urol 1998 Jun;81(6):811-6
Objective: To examine the role of microwave power and blood flow on temperature variations and
tissue destruction in the prostate, using a theoretical model of transurethral microwave thermotherapy
(TUMT), and thus compare fixed-energy TUMT with no intraprostatic temperature monitoring (constant
microwave power applied over a fixed period) with 'feedback' TUMT in which the microwave power is
adjusted according to the monitored intraprostatic temperature.
Materials and method: The temperature distribution in the prostate was modelled for a typical TUMT
catheter at various blood flow rates. The volume of tissue destroyed was simultaneously calculated
from cell survival data after thermal exposure. The calculated quantity of tissue destroyed at the
different microwave power levels and blood flow rates was used to describe qualitatively the simulated
treatments.
Results: Treatment monitoring and consistency were better during feedback TUMT than fixed-energy
TUMT, in that the former compensated for variations in blood flow rate. The modelled values agreed
with observations during real TUMT. Conclusions: Blood flow rate is a key factor in the outcome of
TUMT. Only by measuring intraprostatic temperature is it possible to compensate for the large
variations in prostatic blood flow and obtain consistent treatment results. Repeated interruptions
prompted by high rectal temperatures should be minimized and preferably avoided, as the quantity of
tissue destroyed is then greatly reduced, and in extreme cases the treatment is totally ineffective.
3.
Intra-prostatic Blood flow Changes during Feedback Microwave thermotherapy measured by
Positron Emission Tomography
Wagrell* L, Sundin** A, Norlén* B,
Department of Urology* and Department of Radiology and Uppsala PET -centre** University Hospital
Uppsala, Sweden
WCE 1999, Greece
Abstract
Objective: To study the changes of intra-prostatic blood flow during feedback microwave
thermotherapy, using positron emission tomography. (PET)
Patients and methods: Three patients with bladder outlet obstruction (BOO) due to benign prostatic
hyperplasia (BPH) were enrolled for this study; Patients were treated with the ProstaLund device, the
latest model of which has the ability to calculate the intraprostatic blood flow. Treatment was given for
one hour. Five PET scans were done during each treatment to calculate the 3-dimensional blood flow,
using (15O) H20 as the tracer.
Results: The prostatic blood flow increased steeply at the beginning of the treatment for all three
patients by up to 100% at 20 and 35 minutes. For patients number 1 and 2 there was a fast decline in
intraprostatic blood flow at the last scan (55 minutes), clearly seen as a large zone with circulation
arrest centrally in the prostate. The intraprostatic temperature was < 50° C during the first half hour but
increased to 52°- 60° C during the second part of the treatment. Patient number three had a high
blood flow during the entire treatment. A reduction of the blood flow was seen at the end of the
treatment, but not to the same extent as for the other two patients. The intraprostatic temperature did
not exceed 49 °C for this patient.
Conclusion: The large variations in intraprostatic blood flow seen during treatment suggests that
intraprostatic temperature monitoring is mandatory to optimise the treatment. The ProstaLund bio-heat
model calculates the change in intraprostatic blood flow accurately.
4.
Interventional Therapy for Benign Prostatic Hyperplasia
Djanan B, Desgrandchamps F, et al. In: Chatelain C, Denis L, Foo KT, Khoury S, Mc Connell J.
5th International Consultation on Benign Prostatic Hyperplasia (BPH), June 25-28, 2000 Paris, pp 399-
421
Page 410:
"Temperature mapping: Intraprostatic temperature is the key mechanism of thermal injury during
TUMT, thus the ability to control this parameter during the treatment is of paramount importance. The
continuous measurement of intraprostatic temperature during treatment will permit energy to be
delivered in a feedback mode and much superior results are to be expected".
"In conclusion, TUMT has undoubtedly turned the period of adolescence, whithout the descending
slope that other, initially promising modalities, have shown. The intense research on several fields of
TUMT confirms the viability of this treatment, and also offers important progress to our understanding
about the complicated ans still obscure pathophysiology of BPH".
5.
Heat treatment of the prostate: Where do we stand in 2000?
Floratos DL, et al.
Curr Opin Urol 2001; 11:35-41
Abstract:
Various minimally invasive modalities that are aimed at alleviating lower urinary tract symptoms
employ heat-induced ablation of hyperplastic prostatic tissue. Following extensive studies, most of
these modalities were eventually abandoned. High-energy transurethral microwave thermotherapy has
survived, however, and has gained a firm position as a therapeutic modality, along with transurethral
resection of the prostate. Recent research addressed fundamental issues of mode of action of
microwave treatment, and revealed the overall efficacy of this treatment, determined new indications,
and rendered high-energy transurethral microwave thermotherapy more acceptable to the patients.
Insights into intraprostatic vascularization and treatment monitoring were also gained as a result of
these global research efforts.
6.
Cell-kill modelling of microwave thermotherapy for treatment of benign prostatic hyperplasia.
Bolmsjo M, Schelin S, Wagrell L, Larson T, de la Rosette JJ, Mattiasson A.J Endourol 2000
Oct;14(8):627-35
Radiation Physics Department, Lund University Hospital, and Prostalund Operations, Sweden.
Purpose: We investigated whether cell-kill modelling could be used as a mean for predicting the
outcome of microwave thermotherapy for benign prostate hyperplasia (BPH).
Methods: The two models--Henriques' damage integral and Jung's compartment model--were
implemented in a computer program. Real treatment data for 22 patients with BPH who were in
chronic retention were used as input, including measured intraprostatic temperatures and microwave
power. To test if modelling gives results that are consistent with actual observations, comparison with
transrectal ultrasound (TRUS) measurements of the prostate volume before and after treatment was
made. The sensitivity of the computer model for variations in the heat cytotoxicity and the temperature
probe location in the adenoma was also tested.
Results: The average TRUS volume reduction 3 months after treatment was 26 cc, whereas the
corresponding cell kill calculation was 27 cc. The computer model appears to be rather insensitive to
minor uncertainties in heat sensitivity and location of the intraprostatic reference temperature sensors.
Conclusion: Cell-kill modelling appears to give results that are consistent with actual observations.
The coagulated tissue volume is calculated in real time during the treatment, thereby providing an
immediate prediction of the treatment outcome. By using cell-kill modelling, the endpoint of a treatment
can be set individually; e.g., when a certain volume reduction has been achieved.
7.
Aspects on transurethral microwave thermotherapy of benign prostatic hyperplasia.
Wagrell L, Schelin T, Bolmsjo MB, Mattiasson A.
Tech Urol. 2000 Dec;6(4):251-5. Review.
The underlying principle behind new minimal invasive procedures, such as microwave thermotherapy,
is to coagulate the prostatic adenomatous tissue by means of heat. This article describes the action of
heat on tissue and identifies areas of concern during treatment. The extent of the necrosis during
treatment is governed by two physical variables: the intraprostatic temperature and the duration of the
heat exposure. The prostatic blood flow is a key factor for the outcome of microwave treatment
because it acts as a coolant and may effectively sink the temperature in the treatment area. Blood flow
can vary substantially between patients and may change significantly during treatment. By measuring
the intraprostatic temperature and varying the microwave power accordingly, it is possible to
compensate for the large variations in prostatic blood flow and obtain consistent treatment.
8.
Microwave Thermotherapy in Patients with Benign Prostatic Hyperplasia and Chronic Urinary
Retention
Schelin S.
Department of Surgery, County Hospitalof Kalmar and Specialistlärkargruppen in Kalmar, Sweden
Eur Urol 2001;39:400-404
Abstract
Objective: To evaluate microwave thermotherapy as a treatment option tor benign prostate hy-
perplasia (BPH) in patients with chronic retention and an indwelling catheter.
Patients and Methods: 24 unselected patients, 53-91 years aid (mean age 73 years) with chronic
urinary retention and an indwelling catheter were treated with Prostalund Feedback Treatment(r).
Patients had had an indwelling catheter tor 1-12 months prior to treatment. Prostalund Feedback
Treatment is an enhanced microwave treatment where the actual intraprostatic temperature is
monitored and used to control the microwave power.
Results: 19 (80%) of the 24 patients were successfully relieved of their indwelling catheter with
satisfactory peak flow, residual urine and symptom score. Treatment failed in 5 (20%) out of the 24
cases. The reasons of failure were identified in all 5 cases and indicate that the method may be less
suitable in case of a median lobe or large protruding lobes into the bladder. There were no serious
complications such as bleeding requiring hospital intervention, sepsis or urine incontinence. Isolated
cases of urinary infection occurred.
Conclusion: The satisfying outcome of a 1-hour-long out-patient procedure tor this patient category
suggests that Prostalund Feedback Treatment may be a good alternative to surgery tor BPH patients
with chronic retention and an indwelling catheter.
9.
Prostalund Microwave Feedback Treatment Compared With TURP For Treatment of BPH: A
Prospective Randomized Multicenter Study.
Thayne Larson, Scottsdale, AZ, Sonny Schelin, Kalmar, Sweden, Anders Mattiasson, Lund, Sweden,
Bo Magnusson, Moddy Schain, Kristianstad, Sweden, Hakan Ageheim, Hudiksvall, Sweden, Jonas
Richthoff, Ljungby, Sweden, Jens Duelund, Kurt Kroyer, Fredriksberg, Denmark, Jorgen Nordling,
Herlev, Denmark, Emmett Boyle, Toledo, OH, Lennart Wagrell, Uppsala, Sweden
Abstract, AUA Anaheim, 2001
Introduction and Objectives: Does microwave thermotherapy which is guided by the actual tissue
temperature provide better treatment outcome and control? We have evaluated transurethral
microwave thermotherapy with intraprostatic temperature monitoring -
ProstaLund Feedback Treatment (PLFT) - vs TURP for treatment of BPH.
Methods: The study was dolle at 10 centers in USA and Scandinavia. 154 patients with BPH were
randomized to PLFT or TURP. Treatment evaluation included TRUS, IPSS, QoL, Qmax, pressure/flow
and adverse events. Patients were evaluated at 3, 6 and 12 months. The intraprostatic temperature
guided the PLFT treatment: the microwave power was adjusted for tissue temperature of 55 ºC.
Results: Significant improvements in IPSS, QoL, Qmax and pressure/flow were observed for both
PLFT and TURP. There was no statistically detectable difference in outcome after 12 months between
PLFT and TURP for either IPSS, QoL, Qmax or detrusor pressure (Mann- Whitney U test). The pro
state volume was reduced by 31% after PLFT and 51% after TURP . IPSS = 7 or minimum 50% gain,
or Qmax =15 ml/s or minimum 50% gain have previously been used to asses responders (deWildt, J Uroll54: 1775, 1995). Using these criteria 82% of the patients were responders in the PLFT group and 86% in the TURP group. Severe adverse events requiring hospitalisation or doctor intervention were more freqent with TURP . Results PLFT vs TURP, mean values

Conclusions: There was no detectable difference in outcome between PLFT and TURP in any of the
study variables: IPSS, QoL, Qmax or pressure/flow. We conclude that the outcome of microwave
thermotherapy with intraprostatic temperature monitoring is comparabie with the results seen after
TURP. As per safety, PLFT appears to be more favourable.
10.
EAU Guidelines on Benign Prostatic Hyperplasia (BPH)
de la Rosette J.M.C.H, Alivizatosb G, Madersbacherc S, Perachinod M, Thomase D,
Desgrandchamps F, de Wildt M.
University Medical Center St. Radboud, Nijmegen, The Netherlands; Athens Medica! School, Athens,
Greece; University Hospita! Vienna, Austria; Ospedale Santa Corona, Pietra Ligure, Italy; Freeman
Hospital, Newcastle uponTyne, UK; Höpital St-Louis, Paris, France
Eur Urol 2001; 40:256-263
Abstract
Objective: To establish guidelines for the diagnosis, treatment, and follow-up of BPH.
Methods: A search of published work was conducted using Medline. In combination with expert
opinions recommendations were made on the usefulness of tests for assessment and follow-up:
mandatory, recommended, or optional. In addition, indications and outcomes for the different
therapeutic options were reviewed.
Results: A digital rectal examination is mandatory in the assessment tor the diagnosis of BPH.
Recommended tests are the International Prostate Symptom Score, creatinine measurement (or renal
ultrasound, uroflowmetry, and postvoid residual urine volume. All other tests are optional. The aim of
treatment is to improve patients' quality of life, and it depends on the severity of the symptoms of BPH.
The watchful waiting policy is recommended for patients with mild symptoms, medical treatment for
patients with mild-moderate symptoms, and surgery for patients who failed medication or conservative
management and who have moderate-severe symptoms, and/or complications of BPH which require
surgery. Regarding non-surgical treatments, transurethral microwave thermotherapy is the most
attractive option. These treatments should be reserved for patients who prefer to avoid surgery or who
no longer respond favourably to medication. Finally, recommendations for follow-up tests and a
recommended follow-up time schedule after BPH treatment are provided.
Conclusions: Recommendations for assessment, possible therapeutic options, and follow-up of
patients with BPH are made.
11.
How does it feel to get a Transurethral Microwave Thermotherapy with ProstaLund Feedback
Treatement?
Ahl, A, Persson B.
Dept. of Health ans Society, Malmö University
Poster with presentation during EAU 2002, Birmingham
Introduction: ProstaLund Feedback Treatment (PLFT(r)) is a transurethral microwave thermotherapy
used for treatment of BPH. Clinical studies have shown th at the outcome after PLFT, in terms of
symptomatic relief and improved urinary flow, is comparable with that seen after TURP. In addition,
PLFT appears to be safer with lower frequency of serious adverse events. The aim of this study was to investigate the patient's experiences during PLFT. Materials and method: Data were collected by observation of patients during PLFT (Bourbonnais instrument) and by semi-structured interviews after the treatment. Totally 20 patients were enrolled. The VAS (Visual Analogue Scale) instrument was used for pain estimation. Emepron, ciprofloxacin, ketorolac or pethidin and diazepam were given as pre-medication. TREATMENT DATA (n=20)

Results: For 65% of the patients the experience of the treatment was in accordance with their
expectations or milder.
Heat: All patients had a heat sensation although 85% did not find this uncomfortable.
Pain: Pain was estimated to an average of 46 mm on VAS (range 0-100 mm).
None of the patients wished to discontinue the treatment due to the pain.
Patients who had moderate to strong anxiety before treatment reported higher pain intensity (VAS).
The pain was located to the urinary tract and the penis.
Urge: All patients experienced urge from the urinary tract, 68% of those patients found this
uncomfortable.
Xerostomia: All patients experienced dry mouth, possibly due to emepron administration.
Observations during treatment
No sign of skeleton muscle response was observed in 30%, of those all except one patient had pain
much below average.
Pulse increased on an average of 25% (range 0-69%).
Blood pressure increased on an average 21% (range 2-65%).
Parameters that have a positive influence on the patients experience
Information and engagement from the staff before and during the treatment, and the procedure to take
care of the patient had a very positive influence.
Medication for urge, pain and anxiousness resulted in relief but had not an optimal effect in 50%.
Decreased microwave power, massage and relaxation eased the experience of urge.
Conclusion: The main part of the patients managed the treatment without considerable
inconvenience. The competence of the staff and good communication with the patients had a strong
influence on the patient's experiences. Knowledge of pre-operative anxiety and a structured
supervision during the treatment can help to discover and reduce the discomfort felt by the patients. All
patients, except one, stated that they would choose PLFT again in case they should need it.
12.
Mediating Transurethral Microwave Thermotherapy by Intraprostatic and Periprostatic
Injections of Mepivacaine Epinephrine: Effects on Treatment Time, Energy Consumption, and
Patient Comfort
Schelin S, J of Endourology Volume 16, Number 2, March 2002
ABSTRACT
Background and Purpose: Profound intraprostatic blood flow may complicate reaching a therapeutic
temperature in the prostate during transurethral microwave thermotherapy (TUMT) for benign prostatic
hyperplasia (BPH). A retrospective survey is presented describing the effect of intraprostatic and
periprostatic administration of mepivacaine epinephrine on treatment time, intraprostatic blood flow,
energy delivery, and patient comfort.
Patients and Methods: Fifteen consecutive obstructed patients with lower urinary tract symptoms
attributable to BPH received TUMT (ProstaLund Feedback Treatment(r)). In order to improve patient
comfort, injections of 10 ml of 0.5% mepivacaine epinephrine were administered in three locations into
the prostate prior to treatment. The results were compared with those of a reference group consisting
of 35 consecutive patients who had received ProstaLund Feedback Treatment without administration
of mepivacaine epinephrine.
Results: Patients who received intraprostatic mepivacaine epinephrine had a shorter treatment time
(32 ± 9 minutes v 61 ± 6 minutes), required less energy (65 ± 27 kj v 172 ± 32 kj), and had a lower
calculated intraprostatic blood flow (13 ± 5 units/minute v 26 ± 12 units/minute) than the reference
group. Patients receiving mepivacaine epinephrine also required less analgesic medication during the
treatment. The clinical outcome in terms of symptom scores and peak uroflow rates appeared to be
similar for the two groups.
Conclusion: Intraprostatic injection of mepivacaine epinephrine prior to TUMT seems to have
beneficial effects. It may represent an important improvement of thermotherapy and enable successful
treatment of those patients who previously failed secondary to a profound intraprostatic blood flow.
13.
ProstaLund Feedback Thermotherapy Versus TUR-P in BPH: a Prospectively Randomized
Study of a Novel Method in Comparison to the Standard Treatment
Samuel F Graber*, Daniel M Schmidt, Reto Tscholl, Franz Recker, Aarau, Switzerland,
Abstract 1444, AUA Orlando june 2002
Introduction and Objectives: To evaluate the efficacy and safety of ProstaLund Feedback Treatment
(PLFT) versus TUR-P in BPH for regulatory purposes; the study was started in April 99 and ended in
October 01.
Methods: Unlike all other microwave devices, the ProstaLund Compact dispenses with urethral
cooling. A temperature sensor in the prostate allows modification of power application and helps in
determination of treatment duration. PLFT was performed in i.v. sedoanalgesia, TUR-P in spinal
anesthesia. In TUR-P, a effort towards a complete resection of the adenoma was made. In this study,
patients with symptomatic BPH were randomized to PLFT or TUR-P in a ratio of 2:1 and followed up
for 12 months.
Results: A total of 62 patients (mean age 67.5 ±9.3 years) were randomized, 61 treated (PLFT 42,
TUR-P 19) and 57 seen at 12 months (PLFT 40, TUR-P 17). Results (preliminary data) at baseline (b)
and 12 months after treatment (12 m) are shown below. All values at baseline were comparable.
There were no safety concerns for either treatment group
Conclusions: PLFT seems to challenge the results of TUR-P after 12 months in BPH, except for a
more substantial removal of prostate tissue in the latter group.
14.
Temperature Mapping, MRI and pathology: Evaluation of ProstaLund Microwave Feedback
Thermotherapy
Christian Huidobro*, Santiago, Chile; Thayne Larson, Scottsdale, AZ; Jean De La Rosette, Hb
Nijmegen, Netherlands; Sonny Schelin, Kalmar, Sweden; Lennart Wagrell, Uppsala, Sweden; Thomas
Gorecki, Kalmar, Sweden; Anders Mattiasson, Lund, Sweden
Abstract 1453, AUA Orlando, june 2002
Introduction and Objectives: What intraprostatic temperatures are reached during microwave
thermotherapy and how does the heat distribution correlate with the treatment outcome expressed as
tissue necrosis? Intraprostatic thermal mapping during the whole treatment session was performed
during ProstaLund feedback microwave thermotherapy (PLFT(r)). Visualization of intraprostatic
changes was made with magnetic resonance imaging (MRI-Gd; before and one week after) and
pathology/ microscopy.
Methods: Eight patients were studied, 3 with BPH and 5 patients with localized prostate cancer;
prostate size 30-60 g. After approval from the local Ethics Committee all were treated with PLFT in
anaesthesia. Up to 40 small temperature sensors in the prostate mapped the temperature distribution.
The intraprostatic pressure was monitored in 2 patients. One week after microwave treatment, the
cancer patients were operated with radical prostatectomy and the specimens were examined
microscopically for cancer as well as for heat induced tissue damage.
Results: The highest temperatures (mean 65°C) were found at or close to the bladder neck. The
temperature fell off towards the apex; 35-40 mm distal to the bladder neck, the temperature was below
the threshold for risk of creating thermal damage (=45C). Therapeutic temperatures were distributed in
a funnel-like shape with a radius of 15 mm at the prostate base, diminsihing towards the apex. MRI
revealed a large zone of non-perfused tissue, of the same shape. With pathology a large funnel-like
zone of necrotic tissue extended from the bladder neck towards the apex. The tissue damage
assessed by the three techniques thus overlapped: destructed tissue at pathology 18 gram, MRI 21 g
and 19 g as estimated from cell kill calculations. Contrary to other devices, PLFT does not aim at
preservation of the prostatic urethral mucosa during treatment, and there was no viable tissue left in
the prostatic urethra. The intraprostatic pressure increased 4 kPa during treatment.
Conclusions: PLFT causes a significant and symmetric tissue necrosis of the prostate, the bladder
neck and the urethral mucosa/ submucosa. Cell kill calculations based on the heat sensitivity and the
thermal distribution appears to estimate the necrotic volume to be very close to that found by
pathology. MRI can be used to visualize the necrotic zone one week after treatment.
15.
Prostalund Microwave Feedback Treatment compared with TURP for treatment of BPH: a
prospective randomized multicenter study with 24 months follow up.
Lennart Wagrell, Sonny Schelin, Jörgen Nordling, Bo Magnusson, Moddy Schain, Håkan Ageheim,
Jonas Ricthoff, Jens Duelund, Kurz Kröyer, , Emmett Boyle, Thayne Larson and Anders Mattiasson
Abstract DUA 2002
Introduction and Objectives: In a prospective randomized multicenter study, we evaluate the effect of
the novel transurethral microwave thermotherapy, ProstaLund Feedback Treatment(tm) (PLFT), vs
TURP for the treatment of BPH.
Methods: The study was conducted at 10 centers in USA and Scandinavia. 154 patients with BPH
were randomized to PLFT or TURP. Treatment evaluation included TRUS, IPSS, QoL, Qmax, full
urodynamics study and adverse events. Patients were evaluated at 3,6, 12 and 24 months. The
intraprostatic temperature guided the PLFT treatment: the microwave power was adjusted for tissue
temperature of 55 C.
Results: Improvements in IPSS, QoL and Qmax were observed for both PLFT and TURP. As
reported previously, the 12 months follow up showed no statistical significant differences in clinical
outcome between PLFT and TURP regarding IPSS, QoL, Qmax or urodynamics (pressure flow). Both
subjective (IPSS and QoL) and objective improvements (Qmax) were maintained also at the 24
months follow up (see table), although the preliminary statistical analysis indicates a slight trend in
favor of TURP. IPSS ( 7 or minimum 50% gain, or Qmax (15 ml/s or minimum 50% gain have
previously been used to asses responders (deWildt, J Urol 154:1775, 1995). Using these criteria 82%
of the patients were responders in the PLFT group and 92% in the TURP group. Severe adverse
events requiring hospitalization or doctor intervention were more frequent with TURP.
PLFT baseline
PLFT 24 month
TURP baseline
TURP 24 month
(cc)
Conclusions: We conclude that the outcome of microwave thermotherapy with intraprostatic
temperature monitoring is comparable with the results seen after TURP. As per safety, PLFT appears
to be more favorable.
16.
Prospective Open Study on PLFT
12-month results
J. de la Rosette,
Nordic Meeting on BPH Focus on Microwave Thermotherapy, Uppsala, Sweden, April 11-13, 2002
In Nijmegen, the Netherlands, patients have been treated with TUMT for several years with good
results. Prostatron and Targis devices (Urologix) have previously been used and I wanted to
participate in a study using the ProstaLund Compact (ProstaLund) in order to confirm the concept of
microwave thermotherapy.
Since many of our patients wished to be treated with TUMT it was not possible to start a randomized
study comparing PLFT with TURP in Nijmegen. The study was designed mainly for registration
purposes (Japan, MHW - Ministry of Health and Welfare) and the objective was to investigate the
efficacy and safety 12 months post PLFT in patients with BPH.
Results: A total of 33 patients completed the study; 42 were enrolled and the reasons for withdrawal
were 1 screening failure, 5 treatment failures, 1 patient request and 2 other reasons. The results after
12 months are convincing; IPSS decreased from 21.9 to 7.1, bother score decreased from 4.2 to 1.4,
Qmax increased from 8.4 ml/s to 17.8 ml/s and the prostate volume decreased from 58 g to 36 g.
Moreover, the correlation between cell kill calculated by the device and tissue necrosis measured by
TRUS was significant.
The most commonly reported adverse events after 12 months were bladder discomfort (20%) and
urinary tract infection (18%). Serious adverse advents were reported by 4 patients (1 vaso-vagal
reaction, 2 epididymitis, 1 urosepsis), all have recovered.
Post treatment catheter time was 18 days. It is very important to communicate with the patients so that
they understand the need for an indwelling catheter for 1-3 weeks post treatment - if they are told they
will accept it.
Conclusions: In summary, the 12 months results are very convincing and the next question is
naturally if we can predict long term data for PLFT based on the data available for other transurethral
microwave thermotherapy devices. My opinion is that based on the results 12 months after PLFT it is
beyond any doubt that the durability for PLFT will be confirmed.
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17.
Feedback microwave thermotherapy versus TURP for clinical BPH--a randomized controlled
multicenter study.
Wagrell L, Schelin S, Nordling J, Richthoff J, Magnusson B, Schain M, Larson T, Boyle E, Duelund J,
Kroyer K, Ageheim H, Mattiasson A.
Department of Urology, Uppsala University Hospital, Uppsala, Sweden.
Urology 2002, aug;60(2):292-9
Objectives: To compare the outcome of a microwave thermotherapy feedback system that is based
on intraprostatic temperature measurement during treatment (ProstaLund Feedback Treatment or
PLFT) with transurethral resection of the prostate (TURP) for clinical benign prostatic hyperplasia
(BPH) in a randomized controlled multicenter study. The safety of the two methods was also
investigated.
Methods: The study was performed at 10 centers in Scandinavia and the United States. A total of 154
patients with clinical BPH were randomized to PLFT or TURP (ratio 2:1); 133 of them completed the
study and were evaluated at the end of the study 12 months after treatment. Outcome measures
included the International Prostate Symptom Score (IPSS), urinary flow, detrusor pressure at maximal
urinary flow (Qmax), prostate volume, and adverse events. Patients were seen at 3, 6, and 12 months.
Responders were defined according to a combination of IPSS and Qmax: IPSS 7 or less, or a minimal
50% gain, and/or Qmax 15 mL/s or greater or a minimal 50% gain.
Results: No significant differences in outcome at 12 months were found between PLFT and TURP for
IPSS, Qmax, or detrusor pressure. The prostate volume measured with transrectal ultrasonography
was reduced by 30% after PLFT and 51% after TURP. Serious adverse events related to the given
treatment were reported in 2% after PLFT and in 17% after TURP. Mild and moderate adverse events
were more common in the PLFT group. With the criteria mentioned above, 82% and 86% of the
patients were characterized as responders after 12 months in the PLFT and TURP groups,
respectively. The post-treatment catheter time was 3 days in the TURP group and 14 days in the PLFT
group.
Conclusions: The outcome of microwave thermotherapy with intraprostatic temperature monitoring
was comparable with that seen after TURP in this study. From both a simplicity and safety point of
view, PLFT appears to have an advantage. Taken together, our findings make us conclude that within
a 1-year perspective microwave thermotherapy with PLFT is an attractive alternative to TURP in the
treatment of BPH.
18.
First report on Microwave Treatment in prostate cancer patients using the ProstaLund
Feedback Treatment principle
Lennart Wagrell M.D., Ph.D. University Hospital Uppsala, Sweden and Jørgen Nordling M.D., Ph.D.
Herlev University Hospital Copenhagen, Denmark
Nordic Meeting on BPH Focus on Microwave Thermotherapy, Uppsala, Sweden, April 11-13, 2002
Purpose: To evaluate ProstaLund Feedback Treatment (PLFT) in prostate cancer patients with Lower
Urinary Tract Symptoms (LUTS)
Materials and Methods: At the University Hospital in Uppsala Sweden, we use the PLFT as the first
line treatment in patients with LUTS due to Benign Prostatic Hyperplasia (BPH). PLFT is a
transurethral microwave treatment using a temperature probe placed in the prostatic tissue to measure
the intraprostatic temperature online during the treatment. This makes it possible to tailor the treatment
for each and every patient. The treatment is given mainly without anaesthesia but sometimes sedation
is needed. The treatment time is in the range 30-60 minutes.
Patients with incurable prostate cancer often present with LUTS or urinary retention. At Uppsala
hospital 18 prostate cancer patients with LUTS or retention were treated with PLFT during 1998 -
2000. All patients were followed up 3 month post treatment. Ten patients were in retention with
indwelling catheter, while the remaining 8 had disturbing LUTS and were in need for treatment. Mean
age for the patients in retention were 77 year and the 8 LUTS patients had a mean age of 79. Six
patients in the retention group and 4 patients in the LUTS group were on hormonal treatment.
Results: At the three months follow up 9 out of 10 patients in the retention group were relieved from
the indwelling catheter. Their maximum urinary flow were 11 ml/s (range 3,8-22) and the residual urine
were 92 ml (range 20-350). PSA were preoperatively 14 (range 0,4-27) and at the three months follow
up 18,2 (range 0,4-51). Nine out of 10 patients stated that they were satisfied with the treatment. The
unsatisfied patient had large residual urine volume at the follow up and is now on CIC. Urodynamic
investigation made on this patient showed no infravesical obstruction but revealed bladder weakness.
For the 8 patients in the LUTS group the maximum urinary flow increased from 5,1 ml/s (range 1,2-9)
to 10,3 ml/s (range 5,4-20,7). The residual urine volume decreased from 111,5 (range 0-250) to 65,2
ml (range 0-111), and the PSA increased from 23,1(range0,5-78) preoperatively to 30,7 (range 0,4-
107) at the three months follow up.
Conclusions: Our results indicate that transurethral microwave thermotherapy with PLFT may be an
interesting alternative for prostate cancer patients with LUTS or urinary retention . In this retrospective
survey we found that 9 out of 10 patients were relieved from retention and that the urinary flow
increased 100% and the residual urine decreased with 50% in patients with LUTS.
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Source: http://www.pelvitec.nl/pelvitec/server/files/pages/410/publicaties_prostalund.pdf