Wissenschaftliche Studien und Referenzen zu PLFT

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.

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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.
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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.

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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".

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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.

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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.

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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.

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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.

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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 .

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.

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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.
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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.

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.
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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.

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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.

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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.

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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.

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.
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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.

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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.