What is CoreTherm®?
CoreTherm® microwave therapy is the new generation of thermotherapy for treating symptomatic BPH. Other thermotherapy systems use standard methods to treat the patient without considering the individual effects of internal blood flow differences in the prostate of each patient. This can greatly affect the internal temperature of the prostate and therefore also the results of therapy.
CoreTherm® uses a patented intraprostatic temperature sensor to measure the actual tissue temperature at three internal prostatic sites. This data is used by the CoreTherm® system’s software to provide the treating physician with the following information:
– Real-time measurement of the internal temperature reached in the prostate.
– The dynamic changes in intraprostatic blood flow during therapy.
– Estimated cell kill in the tissue by real-time evaluation of tissue necrosis based on the actual temperature reached and treatment duration.
All of this information allows the treating physician to adjust the therapy by modifying the microwave power effect administered and the therapy time so that the desired result is achieved for each patient.
A CoreTherm® system includes: A control unit, laptop computer with therapy software, internet cable, calibration kit, microwave antenna, intraprostatic temperature sensor, rectal temperature probe and penis sensor.
What is PLFT/CoreTherm®?
PLFT is the old name for this therapy. It is now called CoreTherm®. PLFT is an acronym for ‘Prostalund Feedback Treatment’. ‘Feedback’ refers to the data fed back to the treating physician about the actual temperature in the tissue throughout the therapy, the amount of tissue coagulation and the changes in intraprostatic blood flow during the therapy.
What are the differences between CoreTherm® and other microwave therapies?
CoreTherm® allows better treatment control than other devices on the market. Its unique properties and patented design make it the most advanced minimally invasive procedure currently available for BPH therapy. No other minimally invasive microwave therapy system has the same performance capabilities.
Exact monitoring of intraprostatic temperature:
By monitoring the exact temperature in the prostate during the procedure the treating physician can see the real-time effects while administering the therapy. Therapy is basically a blind treatment if there is no way to assess the therapy administered. This means a greater risk of undertreatment or overtreatment. Tissue temperature is the key to treatment success. Temperature and treatment duration are the two primary parameters that determine the outcome of the therapy. It is therefore necessary to monitor the temperature in the prostate to administer optimal treatment.
Estimating cell kill:
CoreTherm® calculates the amount of tissue coagulated by the heat administered using biological data about the heat-sensitivity of the prostate tissue. Threshold parameters that induce heat necrosis are 60 minutes at 45°C, 5 minutes at 55°C, 2 minutes at 60°C or 1 minute at 70°C
See literature references:
1. Bhowmick et al. In vitro assessment of the efficacy of thermal therapy in human benign prostatic hyperplasia, Int J Hyperthermia, 20:4, 421-439, 2004
2. Huidobro C et al., Evaluation of ProstaLund CoreTherm®microwave thermotherapy with histopathology, magnetic resonance imaging and temperature mapping. Journal of Urology, 171, 672-678, 2004
If the prostate tissue temperature is not known the treatment administered consequently becomes more random and less predictable.
Adjustable microwave power effect/temperature regulation:
CoreTherm® enables the treating physician to exactly adjust the temperature to treat the needs of the individual patient. This is vital in reducing both overtreatment and undertreatment risks.
Short treatment time:
CoreTherm® treats patients in 10-15 minutes (Does not apply in US yet, waiting product approval by FDA), while other devices for administering microwave thermotherapy require fixed treatment times, commonly 30 to 60 minutes. For the patient this can be a crucial advantage.
Best results:
CoreTherm® is the only minimally invasive microwave thermotherapy device that consistently reduces patient symptoms from severe to mild.
Reliable results:
Clinical studies have demonstrated that CoreTherm® has the highest success rate in terms of treatment outcome and is comparable to TURP.
[Wagrell L et al., Feedback microwave thermotherapy versus TURP for clinical BPH: a randomized controlled multicenter study, Urology 60: 292-299,2002].
Extra safety:
CoreTherm® continuously monitors the temperature in the prostate in real-time and calculates the amount of tissue coagulation. CoreTherm® also takes other body-temperature readings as additional safety measures i.e. rectal temperature and the temperature between the penis and scrotum. The device also shuts off if these temperatures exceed set safety temperature limits. The latter is a default safety feature if the catheter should dislodge from its position.
What are the CoreTherm® indication criteria?
CoreTherm® is indicated for symptomatic BPH with a prostate size > 30 g and a prostatic urethral length of at least 35 mm.
Is CoreTherm® an outpatient procedure?
Yes. CoreTherm® does not require a general anaesthetic and the therapy is suitable for outpatient administration at a clinic. All that is required is an electricity supply and a therapy table. The patient can go home once the procedure is completed.
Can high-risk patients who can’t have surgery be treated using CoreTherm®?
Yes. With CoreTherm® risks associated with anaesthesia, bleeding and TUR syndrome are avoided.
How long does the procedure take?
All patients are unique. In some patients a high temperature is attained in the prostate in a few minutes, while therapeutic temperatures may take longer to achieve in others. The average treatment time for CoreTherm® is 10 to 15 minutes. In rare cases, i.e. if there is a strong enough blood flow in the patient’s prostate to cool the prostate and prevent the therapeutic temperature being achieved, the treatment time can take up to one hour.
Have randomised clinical studies been carried out for CoreTherm®?
Yes. Several clinical studies and clinical evaluations have been carried out that verify the safety and efficacy of CoreTherm®. The most comprehensive study, which involved 146 patients, was carried out as a multicentre study in the US, Sweden and Denmark. This compared CoreTherm® and TURP, with follow-up after 12, 24 and 36 months. *The study variables included IPSS (=AUA symptom scores), assessments of the extent of discomfort and Q-max (maximal urine flow). During the entire study CoreTherm® and TURP demonstrated equal efficacy, but CoreTherm® had a far superior safety profile. Of the patients who underwent TURP 17% experienced serious side effects compared to 2% of the patients treated with CoreTherm®. (Serious adverse events are defined as events requiring hospital intervention). The most common side effect with CoreTherm® was hematuria.
* Wagrell L et al., Three year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a randomized controlled multicenter study, Urology 64: 698-702, 2004