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Clinical Experience with Direx Tempro System in the Treatment of the Lower Urinary Tract Symptoms, Following BPH Using Radio Frequency

Martín Bazaco, Jesus; Acha Perez, Marks;Padilla Snows, Jesus; Villafruela Mateos, Ainara;Llarena Ibarguren, Robert; Pertusa Rock, Carlos

Hospital de Cruces, Bilbao, Vizcaya Department of Urology
Martín Bazaco, Jesus; Acha Perez, Marks;Padilla Snows, Jesus; Villafruela Mateos, Ainara;Llarena Ibarguren, Robert; Pertusa Rock, Carlos
World Congress of Endourology 2007 , Cancun Mexico

Introduction

Although the TURP is considered the gold standard for surgical treatment of BPH, new minimally invasive therapies alternatives, are being developed to alleviate the BPH symptoms while reducing the risks. The Direx Tempro© provides a thermotherapy treatment, by means of Bipolar Radio Frequency waves of energy, delivering them through a special 16 FR catheter, with electrode rings placed in the prostatic urethra.

 tempro31a_200
 tempro2a_200

Materials and Methods


Between May of 2005 and May of 2007, we used the Direx Tempro Radio Frequency system to treat 75 patients,ages ranging between 59 and 93 years, (average 75 years), with significant BPH pathology. The exclusion criteria were patients who presented large Median Lobe and those whose Prostatic urethra length was bigger than 49 mm. The treatment consist in a single session of 60 minutes at a temperature of 55ºC. The treatment is ambulatory, requiring only intra-urethral local anesthesia. The volume of the prostates ranges were between 20 and 70 cm3 (with an average of 39 cm3) and with a Prostatic urethral length ranging between 20 mm and 48 mm (average was 35 mm).

Two group of patients were treated
A) Patients with symptomatic BPH that are considered moderate to high surgical risk with an average IPSS of 21 and a Qmax Flow average of 8,4 ml/sec.

B) Patients with Acute Urinary Retention in which the Indwelling Catheter can not be avoided. 

Total Number of Patients Treated
with Tempro R.F. (n=75)
temprograph205_11 
 Patients with Accute urrray Recntion
temprograph206_11   Patients with Sytoms BPH
 temprograph204_123
Results

The evaluation of the clinical results included: the-IPSS (International Prostate Symptom Score) and the Maximum Flow (Qmax), tested at 1 month, 3 months, 6 months, 1 year and 2 years, follow up.

A) Patients with symptomatic BPH:

ISPP as a Function of Time Post Treatment  ISPP% Imrovement
 temprograph200_225  temprograph201_225

With a follow up range between 1 and 24 months (average of 13 months), we have seen a reduction in IPSS score of 50% and this is maintained during the follow period.

 

  Q Max Post Treatment  Q Max Imrovement
 temprograph202_225  temprograph203_225

Regarding the Maximum Flow, we have seen a continuous increase up to 50%. This improvement was maintained during the whole follow up period.

Patients with Acute Urinary Retention

We obtained a success rate of 72%, eliminating the indwelling catheter and with negative Post- Void Residuals (PVR) with a follow up range of 1 to-24 month an average follow of 13 months.

Complications

The complications were mild: 58% of the patients had temporary urinary irritation, which was perfectly controlled with anti-inflammatory alpha-blockers drugs. Transitory Acute Retention in 9.5% of the cases and initial hematuria in 20% of the patients.


Conclusion

The TEMPRO© treatment has been effective in both groups of patients, with a low complication rate and practically with secondary side effects, therefore very advantageous for the treatment of aged patients and patients with serious BPH symptoms. These initial results are very promising. Additional studies are being made to evaluate the long-term effectiveness of this method.

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