Dr . C. Beck; Institute for Thermotherapy; Dortmund-Germany
World Congress of Endourology ,2006 Mumbai, India

Introduction
Although TURP is considered the Gold Standard to treat BPH, several minimal invasive alternatives were lately developed to alleviate symptoms while reducing risks.

Thermotherapy Devices deliver heat into the Prostate, producing coagulation of hypertrophic tissue. Coagulated tissue will be absorbed and will alleviate LUTS, especially in intermediate stages of BPH development. Most of the existing devices use Microwave as a source of energy. I report here of my initial clinical experience with a novel device, the Direx Tempro_^®, that uses Bipolar Radio Frequency as an energy source. 

	Heat rings      Inflatible balloon
	Urine drainage bag connection  Bladder drainage opening

Materials and Methods
The purpose of the study was to assess the safety and efficacy of the Direx Tempro^®.
This Thermotherapy RF system, uses an Applicator that is composed of a special 16-Fr Foley Catheter with 6 Ring Electrodes, and 3 built in temperature sensors. The rings are mounted on the catheter , the first is located 5mm below the Bladder Neck, the next 5 Rings are positioned at 5 mm distance one from each other.Bipolar R.F. energy is delivered to various combinations of ring pairs; allowing

a) Treatment of Different Prostate Sizes Using From 2 to 6 Electrodes

b) Treatment with 3 Different Heat Patterns

Temperatures are measured with the three sensors and allow computer shaping of the heating patterns into 3 Shapes: Cylindrical ,Conical and Spherical.

Efficacy was assessed by evaluating 3 parameters: IPSS, QoL and Qmax performed at Pre-Treatment, 1 month and 3 months follow up. Success criteria was considered to be the improvement of 50% or higher in at least one of the evaluation parameters.

Treatments were considered unsuccessful when none of the success criteria parameters were met. Deterioration was considered in case one of the parameters was worsened.

Thirty patients, average age 70 years (range 50 to 91 ) with BPH symptoms, IPSS average 20 ( +/- 3.7 ), were treated for 1 hour at an average temperature of 52 °C (range 50 to 55 °C), with a uniform "Cylindrical" heat pattern.

Results

1. Efficacy
Only moderate improvements were achieved after 1 month. This includes 24% of treatments with patient deterioration . Considerable improvements were found at the 3 months follow up where 93% of patients met the success criteria, 7% were unsuccessful without deterioration.

2. Complications
Treatment was well tolerated by 27 out of 30 patients (90%). All patients were released after the treatment without indwelling catheter. Afterwards, 6 out of 30 patients required a catheter for 2-4 days (20%). Serious complications like: Stricture, Impotence, Retrograde Ejaculation and UTI, were not found .

Conclusion
The treatment with the Direx Tempro® seems Safe and Effective, with success rates of 93% at 3 months. Deterioration of 1 month can be related to an inflammatory reaction to the thermal treatment. Additional follow up must be done in order to evaluate treatment outcomes over time.

Further experience is needed to fully assess the potential of this device, and different heating patterns will be evaluated in future. The Optimal results and minimum indwelling catheter time at post treatment are very encouragin.