Clinical studies & Publications
Transurethral microwave thermotherapy with the CoreTherm® Concept in men with prostates larger than 100 grams – a consecutive case series
Winck-Flyvholm L et al. Scand J Urol. 2025;60:23-28
Objective: Transurethral microwave thermotherapy (TUMT) is well described for lower urinary tract symptoms in men with prostates between 30 and 100 grams. We aimed to describe the results in men with prostates larger than 100 grams.
Material and methods: We retrospectively recorded age, prostate size, occurrence of urinary retention, and Danish Prostate Symptom Score (DAN-PSS) prior to treatment in men with prostates exceeding 100 grams. Following treatment, we assessed satisfaction, DAN-PSS, and the results of uroflowmetry and postvoid residual urine.
Results: We included 50 consecutive patients with prostates over 100 g. The median age was 78 years, and the median prostate size was 126 g (range 101–230). Forty-four men were treated due to urinary retention and 6 due to lower urinary tract symptoms. Treatments were performed under local anesthesia. The median duration was 15 minutes (range 8–32 minutes) and the median destruction was 25% of the prostatic volume (range 11–26%). Eight patients had destruction of <20%. No side effects were noted. Forty-nine patients completed 6-month follow-up. The 41/49 (84%) men who had tissue destruction of ≥20% reported to be satisfied. The median DAN-PSS score was 3 (range 0–18), the median Qmax was 12 mL/s (range 5.1–23.1 mL/s) and the median postvoid residual volume was 89 mL (range 0–331 mL). Symptoms were unchanged in the 8/49 (16%) men who had <20% tissue destruction.
Conclusions: TUMT represents a useful alternative to surgery in men with infravesical obstruction and a prostate of more than 100 grams.
Does the CoreTherm® Concept Offering Transurethral Microwave Temperature Feedback Thermotherapy or Transurethral Resection of Prostate for Benign Obstruction have an Impact on Long-term Risk for Prostate Cancer Incidence and Mortality? Results from a Long time Nationwide Observational Cohort Investigation.
Stenmark F et al. J Nephrol Urol Andrology. 2024;2:01-08
Background and Hypothesis: Intraprostatic hyperthermia <45° beyond ablation necrosis at ≥45° during CoreTherm® Concept (CT) treatment, a further developed TUMT, for benign prostate hyperplasia (BPH) may influence prostate cancer-related occurrence and death later in life.
Objective: To assess the risk of prostate cancer morbidity and mortality in men with BPH following thermotherapy/hyperthermia and transurethral resection of the prostate (TURP).
Design, Setting, and Participants: A nationwide, population-based study 1999-2019 in Sweden based on the Patient Register to identify cases of CT treatments (n= 4,686) and TURP (n= 74,527). Incident cases of prostate cancer were identified by linkage to the National Cancer Register.
Outcome Measurements and Statistical Analysis: Prostate cancer diagnosis and cancer-related mortality were the main outcome measures. Risks were calculated using hazard ratios (HRs) with a 95% Confidence interval (CI).
Results and Limitations: CT did not decrease the overall risk of being diagnosed with prostate cancer compared to TURP (HR 0.91, CI 0.79-1.04). For men above median age (71 years), CT decreased the risk for prostate cancer overall (HR 0.77, CI 0.64–0.92) and prostate cancer-specific death in the short-term (HR 0.51, 95% CI 0.32-0.83), long-term (HR 0.48, 95% CI 0.26-0.90) and overall (HR 0.66, 95% CI 0.49-0.87) compared to TURP. Age at intervention, age at diagnosis, and age at prostate cancer-related death did not differ significantly between the treatment groups overall.
Conclusions: Among men treated after 71 years of age CT for BPH was associated with an overall lower risk for a prostate cancer diagnosis later in life and a significantly decreased risk for prostate cancer-related death compared to TURP.
Clinical experience and video description of minimally invasive surgery for benign prostatic obstruction using the Schelin Catheter®
Barriere H et al. The French Journal Urology (2024)
Abstract
Holmium laser enucleation of the prostate with transurethral intraprostatic anesthesia using Schelin catheter: a preliminary communication
Romagnoli D et al. The Cent European J Urol. 2024;7: 273-277.
Introduction: This study was aimed to evaluate the feasibility, safety, and advantages of the use
of transurethral intraprostatic anesthesia (TUIA) using Schelin CatheterTM (SC) in patients undergoing
holmium laser enucleation of the prostate (HoLEP).
Material and methods: TUIA was performed using SC, a catheter equipped with an operative channel
with a retractile needle, a standard drainage outlet, and a balloon port. After inserting the SC into
the patient’s urethra and filling the balloon to anchor it in the bladder neck, four target injections
with local anesthetic were performed, one in each quadrant in the base area of the prostate.
After injections, the catheter was removed and the HoLEP procedure started. During the procedure,
patients also received moderate sedation/analgesia.
Results: We selected two 63-year-old patients with good performance status. Prostate volume
was 40 ml for the first patient and 31 ml for the second. TUIA and HoLEP operative times were
68 minutes in the first patient and 42 minutes in the second.
During the procedure, patients complained of only minimal discomfort, and during hospitalization
patients’ numeric rating scale (NRS) pain score ranging from 1 to 0, with no need for additional
analgesics. No complications were reported perioperatively and 15 days after the procedure.
Conclusions: This is the first report on TUIA via SC in patients undergoing HoLEP. In our preliminary
experience, TUIA via SC was safe and feasible, showing complete perioperative pain control.
Further studies are needed to confirm these promising results and better define the category
of patients eligible for this type of treatment.
https://ceju.online/journal/2024/benign-prostatic-hyperplasia-lower-urinary-tract-symptoms-2343.php
Treatment with CoreTherm in 570 patients with prostate volumes of 80-366 ml: an evaluation of short- and long-term retreatment risk.
Stenmark F et al. Scand J Urol. 2022;56:336-341
Introduction: CoreTherm (ProstaLund AB, Lund, Sweden) is an outpatient treatment option in men with lower urinary tract symptoms and catheter-dependent men with chronic urinary retention caused by benign prostatic obstruction (BPO). CoreTherm is high-energy transurethral microwave thermotherapy with feedback technique. Modern treatment with CoreTherm includes transurethral intraprostatic injections of mepivacaine and adrenaline via the Schelin Catheter (ProstaLund AB, Lund, Sweden) and is often referred to as the CoreTherm Concept.
Objectives: The aim of this study was to evaluate the short- and long-term retreatment risk in men with large prostates and BPO or chronic urinary retention, all primarily treated with CoreTherm.
Material and Methods: All men from the same geographical area with prostate volumes 80 ml treated 1999–2015 with CoreTherm and having BPO or were catheter-dependent due to chronic urinary retention, were included. End of study period was defined as December 31, 2019.
Results: We identified and evaluated 570 men treated with CoreTherm, where 12% (71 patients) were surgically retreated during the follow-up. Mean follow-up was 11 years, and maximum follow-up was 20 years. The long-term retreatment rate in our study was 23%. A majority of these could be retreated with CoreTherm or TURP, with only 3% requiring open surgery.
Conclusion: We conclude that CoreTherm is a suitable outpatient treatment option in patients with profoundly enlarged prostates, regardless of age, prostate size, and reason for treatment.
Prostate volume and age are predictors of energy delivery using the CoreTherm Concept in patients with LUTS/BPO: a study on thermal dose.
Stenmark F et al. Scand J Urol. 2020;54:248-252
Objective: The primary aim of this study was to evaluate the scientific evidence supporting the use of thermal dose as a secondary (or an alternative) endpoint when using the CoreTherm Concept.
Material and methods: Baseline and treatment data from 283 consecutive treatments were evaluated. All patients had lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). After evaluation, benign prostatic enlargement (BPE) with benign prostatic obstruction (BPO) was evident. As treatment, the CoreTherm Concept was used in all patients with LUTS/BPO. Data parameters were retrospectively extracted and included patient age, prostate volume, energy delivery, treatment time and calculated cell kill. In addition, assessment of temperature curves and calculated intraprostatic blood flow was made to define an optimal treatment. In total, 199 treatments assessed as optimal were included in the study.
Results: There was a significant correlation between pretreatment prostate volume and energy delivery (p<.001). Age also influenced energy consumption significantly (p=.01).
Conclusion: The solid correlation between pretreatment prostate volume and age versus total energy deposition implies the recommendation that a pretreatment calculation of an appropriate energy deposition should be used in all treatments as an alternative treatment endpoint.
High-energy feedback microwave thermotherapy and intraprostatic injections of mepivacaine and adrenaline: an evaluation of calculated cell kill accuracy and responder rate.
Stenmark F et al. Scand J Urol 2014;48:374-378
Objective: The aim of this study was to evaluate cell kill accuracy and responder rate when using injections of intraprostatic mepivacaine and adrenaline (MA) before high-energy microwave thermotherapy (HE-TUMT).
Material and methods: This retrospective evaluation encompassed 283 treatments in men with lower urinary tract symptoms or urinary retention due to benign prostatic hyperplasia. They were treated consecutively during 2003-2008 using HE-TUMT with a feedback technique. Immediately before treatment, MA was administered into the prostate via a Schelin Catheter®. Clinical outcome was evaluated 3 months after treatment using a validated symptom score, transrectal ultrasound, peak urinary flow and postvoid residual.
Results: Systematic underestimation of the resulting coagulation necrosis was a consistent finding when using MA, a calculated cell kill of 21% yielding a volume reduction of 26% for prostate volumes less than 100 ml and 31% for prostate volumes greater than or equal to 100 ml. Mean prostate volume was 74 ml and mean treatment time was 13 min. Less than 1% of the patients needed analgesics or sedatives on demand. Analysis of the data showed an estimated clinical responder rate of approximately 87%.
Conclusions: The resulting prostate volume reduction corresponds to the earlier empirically recommended 30% cell kill for CoreTherm® without MA. The treatment concept combining CoreTherm with intraprostatic injections of MA corresponds to the clinical outcome of thermotherapy without MA, with the benefits of reduced pain, shortened treatment time and decreased energy consumption.
Transurethral microwave thermotherapy treatment of chronic urinary retention in patients unsuitable for surgery.
Faurholt M et al. Scand J Urol. 2014;48:290-294
Objective: The aim of this study was to evaluate transurethral microwave thermotherapy (TUMT) in the treatment of chronic urinary retention due to benign prostatic hyperplasia (BPH) in patients unsuitable for surgery.
Material and methods: The study enrolled 124 patients with chronic urinary retention due to BPH. The median age was 80 years (61-92 years). Of the enrolled patients, 77 (62%) were assessed by an anaesthesiologist as being unsuitable for surgery owing to cardiac, pulmonary, neurological or other diseases. Overall, 115 patients (93%) had an indwelling catheter. The remaining nine patients (7%) performed clean intermittent self-catheterization. The treatment was performed under local anaesthesia in the outpatient department using the ProstaLund Coretherm Device. At the 6-month follow-up, the Danish version of the International Prostate Symptom Score (DAN-PSS), postvoiding residual volume and urinary peak flow were measured. Improvement in quality of life was also registered.
Results: The success of TUMT was assessed by looking at the percentage of patients relieved of their catheter and by the improvement in quality of life. Overall, 77% of patients were relieved of their catheter and 79% reported an improvement in their quality of life.
Conclusion: In this study, both the median age and the percentage of patients unsuitable for surgery were larger than in previous studies. Despite this, TUMT relieved 77% of their catheter and 79% reported an improvement in their quality of life. This study shows that TUMT is an effective treatment for patients unsuitable for surgery and with chronic urinary retention.
Five-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study
Mattiasson A et al. Urology 2007;69:91-96
Objectives: To compare the efficacy and safety of transurethral microwave thermotherapy (TUMT) with ProstaLund Feedback Treatment, using the CoreTherm device, with transurethral resection of the prostate (TURP) 5 years after treatment.
Methods: This prospective, randomized, multicenter study was conducted at 10 centers in the United States and Scandinavia. A total of 154 patients with benign prostatic hyperplasia were randomized to TUMT or TURP in a 2:1 ratio. Patients were followed up at 3, 6, 12, 24, 36, 48, and 60 months after treatment. The intermediate results at 12 and 36 months have been previously reported. The treatment outcome at 5 years was evaluated with the International Prostate Symptom Score (IPSS), quality of life question (QOL), peak urinary flow rate (Qmax), postvoid residual urine volume, and prostate volume. The CoreTherm device differs from other microwave devices in that the intraprostatic temperature is constantly measured during the procedure to guide the treatment.
Results: Of the 154 patients, 66% completed the 60 months of follow-up. Statistically significant improvements in the TUMT and TURP groups were observed for IPSS, QOL, and Qmax at 60 months. The average values for the TUMT group were an IPSS of 7.4, QOL score of 1.1, and Qmax of 11.4 mL/s. The values for the TURP group were IPSS of 6.0, QOL score of 1.1, and Qmax of 13.6 mL/s. No statistically significant differences were found in any of these variables between the two treatment groups. In the TUMT group, 10% needed additional treatment versus 4.3% in the TURP group.
Conclusions: The clinical outcome 5 years after TUMT using the CoreTherm device was comparable to the results seen after TURP. The safety of TUMT using the CoreTherm device compared favorably with that of TURP.
Feedback microwave thermotherapy vs TURP/ prostate enucleation surgery in patients with benign prostatic hyperplasia and chronic urinary retention; A prospective randomized multicenter study.
Schelin S et al. Urology 2006;68:795-799
Objectives: To assess the clinical efficacy of ProstaLund Feedback Treatment (PLFT) using the CoreTherm device versus transurethral resection of the prostate (TURP) and prostate enucleation surgery.
Methods: We performed a prospective, randomized, controlled, multicenter study of 120 patients with symptomatic benign prostatic hyperplasia and persistent urinary retention requiring an indwelling catheter or clean intermittent catheterization. The primary efficacy variables were success in catheter removal and symptom improvement.
Results: Of the 120 patients, 79% and 88% were catheter free after PLFT and surgery, respectively. The bother score (quality-of-life question) decreased from 4.6 in both groups before treatment to 1.4 in the PLFT group and 0.8 in the surgery group at 6 months of follow-up. The peak urinary flow rate was 13.4 mL/s after PLFT and 18.0 mL/s after surgery. The mean catheterization time was 34 days in the PLFT group and 5 days in the surgery group.
Conclusions: PLFT is an effective alternative to surgical treatment in this group of catheterized patients. The risk of severe complications is reduced using PLFT, and an excellent treatment option can thereby be offered to this high-risk patient group who earlier could be treated only with lifelong catheterization.
Three-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study
Wagrell L et al. Urology 2004;64:698-702
Objectives: To compare, in a prospective randomized multicenter study, the efficacy and safety of transurethral microwave thermotherapy with ProstaLund Feedback Treatment (PLFT), using the CoreTherm device, with transurethral resection of the prostate (TURP) 36 months after treatment.
Methods: The study was conducted at 10 centers in the United States and Scandinavia. A total of 154 patients with benign prostatic hyperplasia were randomized to PLFT or TURP in a 2:1 ratio. The treatment outcome was evaluated on the basis of the International Prostate Symptom Score (IPSS), the quality-of-life question (QOL) of the IPSS, peak urinary flow rate (Qmax), urodynamics, and adverse events. The microwave power and treatment time were adjusted according to each patient’s response to the supplied energy (ie, the intraprostatic temperature guided the PLFT).
Results: Statistically significant improvements in both the TURP and the PLFT groups were observed for IPSS, QOL, and Qmax at 36 months. The average value for the PLFT group was 8.2, 1.2, and 11.9 mL/s for IPSS, QOL, and Qmax, respectively. The corresponding values for the TURP group were IPSS 5.0, QOL 1.0, and Qmax 13.5 mL/s. The difference in IPSS outcome was statistically significant; however, no statistically significant differences were found in QOL or Qmax between the two treatment groups. The degree of improvement was in the same range as that observed after 12 and 24 months for both groups. During the 12 to 36-month period, the most frequent adverse events in the TURP group were impotence (15%), micturition urgency (13%), and urethral disorder (8%); in the PLFT group, impotence (8%), prostate-specific antigen increase (5%), and hematuria (4%) were the most common.
Conclusions: The clinical outcome 3 years after microwave thermotherapy with PLFT was comparable to the results seen after TURP. The safety of PLFT compared favorably to that of TURP in this study.
Feedback Microwave Thermotherapy versus TURP for Clinical BPH – a Randomized Controlled Multicenter Study
Wagrell L et al. Urology 2002;60:292-299
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.
Mediating Transurethral Microwave Thermotherapy by Intraprostatic and Periprostatic Injections of Mepivacaine Epinephrine: Effects on Treatment Time, Energy Consumption and Patient Comfort
Schelin S. Journal of Endourology 2002;16:117-121
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). 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.