martin
|
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
|
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.
Material 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)
|
 Patients with Accute urrray Recntion
 Patients with Sytoms BPH
|
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
 
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
 
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.
beck
|
INITIAL EXPERIENCE WITH TEMPRO TREATMENT
FOR BPH PATIENTS IN ITALY
|
Maurizio Turriziani, Francesco Esta, A Cupini, A Cefaloni
"Umberto I" Hospital Frosinone Italy
24th World Congress of Endourology
|
Introduction:
Tempro treatment is a new method to treat BPH symptomatic patients. From November 2005 ,we started to treat 2 types of patients:
a)High Surgical Risk patients and b)patients with moderate to severe BPH symptoms.
Method:
The Tempro system uses a special Applicator based on a 16 FR Foley catheter,with ring electrodes which are connected to a Bipolar RF source. We have treated 30 patients with ages 69 to 95 years. Ten patients were High Surgical Risk (ASA IV) with indwelling catheter and 20 patients had moderate to severe BPH symptoms. Ultrasound was usedto evaluate the prostatic urethra length, residual volume and also to exclude Median Lobe patients. Uroflow test were performed pre and 2-3 month after treatment. Patients were treated at a target temperature of 55 Degrees C for 1 hour. Twenty eight patients tolerated well the treatment and 2 required pain killers during the treatment.
Result:
The patients with indwelling catheters were left with a catheter for 2-3 weeks. After catheter removal in 6 out of 10 ( 60%) the treatment was successful(urinating spontaneously). Four patients failed: 2 underwent TURP and 2 are with indwelling catheter.Regarding the 20 symptomatic patients , 14 (70%) had a average Qmax improvement of 55 % at 2-3 months. Two improved slightly and 4 remained unchanged.
Conclusion:
Our initial results show that the Bipolar RF Tempro treatment seems to be a very advantageous treatment for indwelling catheter patients as well as for BPH symptomatic patients.
beck
|
INITIAL EXPERIENCE WITH TEMPRO TREATMENT
FOR BPH PATIENTS IN ITALY
|
Maurizio Turriziani, Francesco Esta,
A Cupini,
A Cefaloni "Umberto I " Hospital, Frosinone, Italy
|
Introduction:
Minimally Invasive procedures are continuously developed to treat BPH. We are reporting here our Initial experience with the Tempro, a new Thermal Treatment device using heat to coagulate selectively a volume of tissue surrounding the Prostatic Urethra.
Some devices using Microwave energy as a source of heat (T.U.M.T.) are available in the market for several years. The Tempro uses a unique technology of Bipolar Radio Frequency energy (T.U.R.F.) with some specific advantages.
The purpose of the study was to asses the safety and efficacy of the Tempro treatment for 2 types of patients:
A) High Surgical Risk patients
B) Patients with moderate to severe BPH symptoms.
Materials and Methods:
The Tempro system uses a unique Applicator based on a 16 FR Foley catheter, with 6 ring electrodes which are connected to a Bipolar RF source.
The Bipolar source can be connected by the Controlling computer to different rings, so as to adapt the heating volume to the Prostatic Urethra Length, previously measured by TRUS.
Between November 2005 and March 2006 we have treated 30 patients, with average age of 72 years (range 69 to 95) the 2 categories mentioned.
Transrectal Ultrasound was used to evaluate the Prostatic Urethra Length, residual volume and also to exclude Median Lobe patients. Uroflow tests were performed, pre and 2-3 month post treatment, for the patients with moderate to severe patients' BPH symptoms. The treatment procedure is easily preformed and consists of inserting the Applicator - similar to the insertion of a simple Foley Catheter. Due to the use of Radio Frequency, there is no need for a Rectal Probe. All patients were treated at a target temperature of 55 Degrees C for 1 hour.
Results were as follows:
I) EFFICACY - Category A - High Surgical Risk Patients
Ten patients with indwelling catheter, who were High Surgical Risk as defined by the American Society of Anesthesiology (ASA) category IV were treated.
The patients were left with a catheter for 2 to 3 weeks.
After catheter removal, in 6 out of 10 (60%), the treatment was successful with patients urinating spontaneously.
In 4 patients the treatment did not succeed
A) 2 underwent TURP
B) 2 are again with indwelling catheter
Category B - Patients with moderate to severe BPH symptoms.
We treated 20 patients in this category.
Efficacy was measured by success of improvement in IPSS symptom Score, Qmax Flow and Quality of life.
Regarding the improvement in Qmax flow, 70% of patients were responders with an average improvement of 55% in Q Max. as follows:
Safety/Complications:
The treatment was well tolerated by 28 patients, and only 2 patients required pain-killers during treatment.
From category B patients, 2 (10%) required an indwelling catheter for 3-4 days.
No serious complications were reported.
Conclusion:
Although ours is a small series, these initial results are very encouraging.
The Tempro treatment being a Minimally Invasive procedure seems to be a very advantageous treatment for indwelling catheter patients as well as for BPH symptomatic patients. Further studies are required to assess this new technology more in depth.
beck
|
A NEW TRANSURETHRAL BIPOLAR RADIO FREQUENCY
DEVICE
FOR BPH THERMAL TREATMENT
ONE YEAR FOLLOW UP
|
Dr . C. Beck; Institute for Thermotherapy; Dortmund-Germany
|
|
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) |
  
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% |
  
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.
beck
|
INITIAL EXPERIENCE WITH TEMPRO
A NOVEL THERMAL TREATMENT
FOR BPH
|
Dr . C. Beck; Institute for Thermotherapy; Dortmund-Germany
|
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.
|
|
Sensor 1
Sensor 2
Sensor 3
|
|
Uniform Cylindrical
Dose |
Upper Conical
Dose |
Mid Spherical
Dose |
|
|
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
.
Conclusions:
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.
|
Pre-Treatment
|
1 Month Follow-up
|
3 Months Follow-Up
|
| Qmax [ml/sec] |
11 |
12.5 |
17.7 |
| IPSS |
20 |
17 |
9 |
| QoL |
5 |
4 |
2 |
| 
