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A New Transurethral Bipolar Radio Frequency Device for BPH Thermal Treatment One Year Follow Up

Dr . C. Beck; Institute for Thermotherapy; Dortmund-Germany

Dr . C. Beck; Institute for Thermotherapy; Dortmund-Germany
Societe Internationale D'Urologie Congress , 2006 , Cape Town, South Africa 


Introduction

Several minimally invasive systems are being offered to the urologist to treat BPH. They include Thermal therapy using Microwave, Monopolar Radio Frequency (T.U.N.A.) and recently a Bipolar Radio Frequency (T.U.R.F.) system called TEMPRO.

The purpose of the study was to assess the safety and efficacy of the new Tempro device. In the past I presented my initial experience, with a 3 month follow up elsewhere (WCE).


Methods
The Tempro uses a special 16 Fr Foley applicator catheter with 6 ring electrodes. The system computer controls the Bipolar RF energy delivery to the prostate using feedback from 3 temperature sensors. Treatment protocols were 550 C, 1 hour and recently 600 C /15 minutes without cooling. Due to the use of Bipolar RF, the heat is concentrated in a small cylinder around the urethra, thereby not requiring a rectal probe.


Results
During the last 18 months, a total of 105 patients were treated with this new system. The inclusion criteria were as follows: patients with a high level of BPH symptoms, (IPSS score >20), moderate Qmax flow (range 6 to 14 ml/sec) and bad Quality of life.
Out of the 105 patients I am reporting the results of the first 30 patients, which have completed at least one year, follow up.
The 3 previous parameters were tested at Baseline (BL), 1 month (1M), 3 months (3M) and 1 year (1YR) or more with the following average and standard deviation results (in brackets). 

IPSS
BL=23.2(3.7) 1M=20.2(7.3)
 3M=8.5(4.7)  1YR=8.2(3.0)
QMax BL=11.4(2.8) 1M=12.5(2.6)  3M=17.4(3.3)  1YR=17.5(2.5)
Qol BL=4.3(0.8) 1M=3.4(1.1)  3M=1.5(0.7)  1YR=1.5(0.5)
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 The average of absolute % of improvement compared to baseline is as follows:

IPSS 1M=12.9% 3M=63.6%
1YR =64.7%
QMax 1M= 9.5% 3M=53.1% 1YR =53.2%
Qol 1M= 20.9% 3M=66.2% 1YR = 65.3%
beckgreytable4a_200  beckgreytable5a_200  beckgreytable6a_200

The treatment was well tolerated by all patients, and no treatment had to be discontinued due to pain. Analgesia used was a small dose of Tramadol drops.
The only side effect was a small percentage of Post Treatment catheterization for 2-4 days.

 

Conclusion
In my experience the Tempro treatment seems to be safe and effective, and provides an important tool to treat BPH symptomatic patients. Optimal results were reached at 3 months and maintained after one year. These results are encouraging.
Additional studies are required to establish the long term effectiveness of this treatment.

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