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1016 Long-term follow-up of interstitial laser coagulation in the treatment of benign prostatc hyperplasia
1013 EAU REAL-LIFE DATA PRELIMINARY RESULTS
REGISTRY
ON
TUNA@
THERAPY:
"1014 PHOTO VAPORISATION OF TIlE PROSTATE VERSUS TRANSURETHRAL PROSTATECTOMY-A RANDOMISED TRIAL
Tubaro A. ~, Hoefner K. 2, Villavicencio H. 3, De la Rosette J.J.'*, Chapple C. s Bouchier-Haves D., Anderson E, Vanappledorn S., Bugeja E, Costello A. ~Sant' Andrea Hospital, Urology, Rome, Italy, aEvangelisches Krankenhans, Urology, Oberhausen, Germany, 3Fundaci6 Puigvert, Urology, Barcelona, Spain, aAcademisch Medisch Centrum, Urology, Amsterdam, The Netherlands, 5Royal Hallamshire Hospital, Urology, Sheffield, United Kingdom INTRODUCTION & OBJECTIVES: A Real Life Electronic Data Registry on Transurethral Needle Ablation (TUNA®) of the Prostate has been set up by the EAU Clinical Research Office in collaboration with Medtronic Sad in November 2003. The registry aims at providing information, from real life practice, on long term clinical outcome and economics of TUNA ® treatments of lower urinary tract symptoms in patients with benign prostatic hyperplasia. MATERIAL & METHODS: The project aims at enrolling 200 patients with a minimum of 5 years follow-up. An electronic, internet based database has been developed (enCapture Advanced Patient Management System). Participating centres can upload patient data which are currently stored on a desktop-based version of the software. The database is property of the EAU. Between December 2003 and September 2004, 12 European centres joined the registry. Registry parameters include: patient's history, International Prostate Symptom Score (I-PSS), quality of life (QoL), International Index of Erectile Function (IIEF5), procedure data and pain/discomfort level related to the procedure; outcome parameters and adverse events are evaluated at 6 and 12 months and then yearly. Quality of uploaded data is certified by an external company. RESULTS: 100 Patients (mean age 67 years) were enrolled in 12 centres in 8 European countries. 99 Patients were evaluable and 6 months follow-up data were available on 42 patients. 63 of 100 patients (63%) had been on pharmacological treatment for LUTS/BPH before enrolment. At baseline, mean prostate size was 42 g and 20 patients (20%) had urinary retention. Peri-operative and post-operative complications were observed in 17 of 99 patients (17%) and in 11 of 42 patients (26%) respectively. 85 Of 100 patients (85%) had an indwelling catheter after the TUNA ®. Acute urinary retention requiring an indwelling catheter occurred in 4 of 42 patients during the first 6 months of follow-up. In the 42 patients with 6 months follow-up, the median total I-PSS improved from 19.0 to 5.0 points and the median QoL score improved from 4.0 points to 1.0 point. The median IEFF-5 slightly increased from 10.5 to 13.5 points. 5 Of 42 patients (12%) were considered as failures at 6 months. CONCLUSIONS: The preliminary results of the Real Life Electronic Data Registry on TUNA ® Therapy confirm the feasibility of this new approach for the evaluation of minimally invasive treatments of BPH and provide a new perspective in clinical research in Urology. We strongly support the collection of real life data for outcome and health and economics research in surgical specialties.
Royal Melbourne Hospital, Urology, Melbourne, Australia I N T R O D U C T I O N & O B J E C T I V E S : Many technologies have been mooted as equal to trans-urethral resection of the prostate (TURP) without gaining widespread acceptance due to lack of randomised trials. The Greenlight®laser system (Laserscope, San Jose, Ca.) gives an 80-watt laser ablation system for prostatic vaporisation (PVP) and here is compared to TURP in the first recorded instance of such a trial. M A T E R I A L & M E T H O D S : 120 patients are randomised to undergo TURP or PVP after evaluation which is repeated at 1, 3, 6, 12 and 24 months. Irrigation use, length of catherisation time (LOC), length of hospital stay (LOS), blood loss and operative time are also assessed. RESULTS: To date 32 patients are evaluable and were matched at baseline. TURP and PVP s h o w e d statistically equivalent increased percent flow rates (102.2±158.1% vs. 170.8±121.9%, p<0.005) and percent improvement in IPSSs (47.36=38 vs. 54.11-~31.9%, p<0.005) over baseline, but TURP showed longer LOC than PVP (40.12±40.9hrs. vs. 13.5±7.9hrs., p=0.0059), and longer LOS than PVP (3.18±l.9days vs. 1.1±0.28days, p=0.0005). Adverse events were less frequent in the PVP group. Results expressed as mean+SD (sample standard deviation). Statistical tests: student-t paired and unpaired. C O N C L U S I O N S : This first randomised trial of the PVP technique in comparison to TURP demonstrates that PVP is an effective technique when compared to TURP, producing equivalent improvements in flow rates and IPSS scores with markedly reduced LOS, LOC and adverse events, Long-term follow-up is being undertaken to ensure durability of these results.
1015
1016
G R E E N L I G H T PVP: S A F E T Y AND E F F I C A C Y IN L A R G E P R O S T A T E S >100ML
LONG-TERM FOLLOW-UP OF INTERSTITIAL LASER COAGULATION IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA Mitsumori K.I, Nishizawa K.2, Kawahara T?, Kobayashi T), Watanabe j.2, Ogura K..3
Chandrasekera S., Barber N., Walsh K., Thompson R, Muir G. King's College Hospital, Urology, London, United Kingdom I N T R O D U C T I O N & OBJECTIVES: The new generation of high-power 80W KTP laser systems have already shown promise in the surgical management of symptomatic BPH. We report our experience in treating patients with large prostate glands using this modality. M A T E R I A L & M E T H O D S : 29 patients with prostate volumes in excess of 100ml (100-240ml) have been treated to date in our institution. 11 presented in acute urinary retention, 4 o f these patients being deemed unsuitable for open prostatectomy due to co-morbidity. 4 patients were fully anticoagulated with warfarin, requiring preoperative conversion to shorter acting agents. One patient needed a mini resection (TURP) (2.5g) at the end of procedure to remove an apical flap. Another had a repeat procedure 3 days post operatively, as part of a planned 2-stage procedure. RESULTS: 26/29 patients were treated on a day-case basis, hospital stay ranging from 5-72hrs. At 6 months, significant improvements in terms of mean IPSS score (18.2 to 8), quality of life score (4.6 to 2.1), and m a x i m u m flow rate (12.5 to 17.5 ml/s) are evident. Mean reduction in prostate volume is 53% (35-67%) on TRUS. There were no cases of TUR syndrome, however, 1 patient with previously k n o w n DVT died at 13 weeks due to a pulmonary embolism.
IHamamatsu Rosai Hospital, Urology, Hamanaatsu, Japan, 2Kyoto University, Urology, Kyoto, Japan, 3Otsn Red Cross Hospital, Urology, Shiga, Japan INTRODUCTION & OBJECTIVES: Although interstitial laser coagulation (ILC) of prostate is effective and less morbid as the treatment of symptomatic benign prostatic hyperplasia (BPH), recent reports showed a high retreatment rate after ILC. To assess long-term satisfaction and the factors, which influence the durability of treatment effect, we evaluated patients with a mean follow-up of about 2 years after ILC. MATERIAL & METHODS: A total of 134 patients (mean 71 year old) who underwent interstitial laser coagulation using Indigo830j (Ethicon Endo-Surgery) between 2000 and 2003 were investigated. The number of sticks was determined according patient's prostate volume (PV). The outcome measures were International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax) and quality-of-life (QOL) indexes and sexual function. Measurements were taken at baseline and at 1, 3, 6 months, and every 6 months after that. The relationship between treatment failure (second surgical interventions) and preoperative factors (age, PV, IPSS, Qmax and the obstruction grading of Schiller) were accessed. RESULTS: Median of preoperative PV, Qmax and IPSS were 4 lml, 7.35ml/sec and 19, respectively. Overall, an improvement of Qmax and IPSS was observed until 6 and 3 months after ILC, and gradually returned after then. QOL index decreased until 3 months after ILC and almost stable thereafter. No change in sexual function was observed. Seventeen cases (12.7%) needed second surgical interventions (TUR-P: 11 cases, re-ILCP: 2 cases, Open prostateetomy: 1 case, others: 3 cases) because their subjective or objective symptoms returned to the preoperative level. The median period to the re-treatment was 474 days (0-i463). Cox regression analysis indicated that smaller PV (<41ml) and severe obstruction (Sehfifer grade >3) are associated treatment failure (Table). Variables Age
Qmax PV Schiller Grade
C O N C L U S I O N S : The high-power 80W KTP laser is a promising modality in the surgical treatment of large prostate glands with minimal morbidity. This technique threatens to assign the open prostatectomy to the history books and certainly offers a safe surgical option for selected patients with very large prostates previously deemed medically unfit for open surgery.
European Urology Supplements 4 (2005) No. 3, pp. 256
IPSS
_>72 <72 >7.3ml/sec <7.3 ->41ml <41 _<3 >3 <19 >19
H.R.
95% C.I.
p values
1.97
0.73--5.30
0.18
1.31
0.46--3.71
0.61
3.01
0.98~9.21
0.05
11.1
1.25--100
0.03
1.18
0.36--2.86
0.76
CONCLUSIONS: The durability of Cojective effect after ILC was limited in a part of patients. Our results suggested that patients with small prostate (who might have bladder neck obstruction) or severe obstruction were not good candidates for ILC.
REGISTRY
ON
TUNA@
THERAPY:
"1014 PHOTO VAPORISATION OF TIlE PROSTATE VERSUS TRANSURETHRAL PROSTATECTOMY-A RANDOMISED TRIAL
Tubaro A. ~, Hoefner K. 2, Villavicencio H. 3, De la Rosette J.J.'*, Chapple C. s Bouchier-Haves D., Anderson E, Vanappledorn S., Bugeja E, Costello A. ~Sant' Andrea Hospital, Urology, Rome, Italy, aEvangelisches Krankenhans, Urology, Oberhausen, Germany, 3Fundaci6 Puigvert, Urology, Barcelona, Spain, aAcademisch Medisch Centrum, Urology, Amsterdam, The Netherlands, 5Royal Hallamshire Hospital, Urology, Sheffield, United Kingdom INTRODUCTION & OBJECTIVES: A Real Life Electronic Data Registry on Transurethral Needle Ablation (TUNA®) of the Prostate has been set up by the EAU Clinical Research Office in collaboration with Medtronic Sad in November 2003. The registry aims at providing information, from real life practice, on long term clinical outcome and economics of TUNA ® treatments of lower urinary tract symptoms in patients with benign prostatic hyperplasia. MATERIAL & METHODS: The project aims at enrolling 200 patients with a minimum of 5 years follow-up. An electronic, internet based database has been developed (enCapture Advanced Patient Management System). Participating centres can upload patient data which are currently stored on a desktop-based version of the software. The database is property of the EAU. Between December 2003 and September 2004, 12 European centres joined the registry. Registry parameters include: patient's history, International Prostate Symptom Score (I-PSS), quality of life (QoL), International Index of Erectile Function (IIEF5), procedure data and pain/discomfort level related to the procedure; outcome parameters and adverse events are evaluated at 6 and 12 months and then yearly. Quality of uploaded data is certified by an external company. RESULTS: 100 Patients (mean age 67 years) were enrolled in 12 centres in 8 European countries. 99 Patients were evaluable and 6 months follow-up data were available on 42 patients. 63 of 100 patients (63%) had been on pharmacological treatment for LUTS/BPH before enrolment. At baseline, mean prostate size was 42 g and 20 patients (20%) had urinary retention. Peri-operative and post-operative complications were observed in 17 of 99 patients (17%) and in 11 of 42 patients (26%) respectively. 85 Of 100 patients (85%) had an indwelling catheter after the TUNA ®. Acute urinary retention requiring an indwelling catheter occurred in 4 of 42 patients during the first 6 months of follow-up. In the 42 patients with 6 months follow-up, the median total I-PSS improved from 19.0 to 5.0 points and the median QoL score improved from 4.0 points to 1.0 point. The median IEFF-5 slightly increased from 10.5 to 13.5 points. 5 Of 42 patients (12%) were considered as failures at 6 months. CONCLUSIONS: The preliminary results of the Real Life Electronic Data Registry on TUNA ® Therapy confirm the feasibility of this new approach for the evaluation of minimally invasive treatments of BPH and provide a new perspective in clinical research in Urology. We strongly support the collection of real life data for outcome and health and economics research in surgical specialties.
Royal Melbourne Hospital, Urology, Melbourne, Australia I N T R O D U C T I O N & O B J E C T I V E S : Many technologies have been mooted as equal to trans-urethral resection of the prostate (TURP) without gaining widespread acceptance due to lack of randomised trials. The Greenlight®laser system (Laserscope, San Jose, Ca.) gives an 80-watt laser ablation system for prostatic vaporisation (PVP) and here is compared to TURP in the first recorded instance of such a trial. M A T E R I A L & M E T H O D S : 120 patients are randomised to undergo TURP or PVP after evaluation which is repeated at 1, 3, 6, 12 and 24 months. Irrigation use, length of catherisation time (LOC), length of hospital stay (LOS), blood loss and operative time are also assessed. RESULTS: To date 32 patients are evaluable and were matched at baseline. TURP and PVP s h o w e d statistically equivalent increased percent flow rates (102.2±158.1% vs. 170.8±121.9%, p<0.005) and percent improvement in IPSSs (47.36=38 vs. 54.11-~31.9%, p<0.005) over baseline, but TURP showed longer LOC than PVP (40.12±40.9hrs. vs. 13.5±7.9hrs., p=0.0059), and longer LOS than PVP (3.18±l.9days vs. 1.1±0.28days, p=0.0005). Adverse events were less frequent in the PVP group. Results expressed as mean+SD (sample standard deviation). Statistical tests: student-t paired and unpaired. C O N C L U S I O N S : This first randomised trial of the PVP technique in comparison to TURP demonstrates that PVP is an effective technique when compared to TURP, producing equivalent improvements in flow rates and IPSS scores with markedly reduced LOS, LOC and adverse events, Long-term follow-up is being undertaken to ensure durability of these results.
1015
1016
G R E E N L I G H T PVP: S A F E T Y AND E F F I C A C Y IN L A R G E P R O S T A T E S >100ML
LONG-TERM FOLLOW-UP OF INTERSTITIAL LASER COAGULATION IN THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA Mitsumori K.I, Nishizawa K.2, Kawahara T?, Kobayashi T), Watanabe j.2, Ogura K..3
Chandrasekera S., Barber N., Walsh K., Thompson R, Muir G. King's College Hospital, Urology, London, United Kingdom I N T R O D U C T I O N & OBJECTIVES: The new generation of high-power 80W KTP laser systems have already shown promise in the surgical management of symptomatic BPH. We report our experience in treating patients with large prostate glands using this modality. M A T E R I A L & M E T H O D S : 29 patients with prostate volumes in excess of 100ml (100-240ml) have been treated to date in our institution. 11 presented in acute urinary retention, 4 o f these patients being deemed unsuitable for open prostatectomy due to co-morbidity. 4 patients were fully anticoagulated with warfarin, requiring preoperative conversion to shorter acting agents. One patient needed a mini resection (TURP) (2.5g) at the end of procedure to remove an apical flap. Another had a repeat procedure 3 days post operatively, as part of a planned 2-stage procedure. RESULTS: 26/29 patients were treated on a day-case basis, hospital stay ranging from 5-72hrs. At 6 months, significant improvements in terms of mean IPSS score (18.2 to 8), quality of life score (4.6 to 2.1), and m a x i m u m flow rate (12.5 to 17.5 ml/s) are evident. Mean reduction in prostate volume is 53% (35-67%) on TRUS. There were no cases of TUR syndrome, however, 1 patient with previously k n o w n DVT died at 13 weeks due to a pulmonary embolism.
IHamamatsu Rosai Hospital, Urology, Hamanaatsu, Japan, 2Kyoto University, Urology, Kyoto, Japan, 3Otsn Red Cross Hospital, Urology, Shiga, Japan INTRODUCTION & OBJECTIVES: Although interstitial laser coagulation (ILC) of prostate is effective and less morbid as the treatment of symptomatic benign prostatic hyperplasia (BPH), recent reports showed a high retreatment rate after ILC. To assess long-term satisfaction and the factors, which influence the durability of treatment effect, we evaluated patients with a mean follow-up of about 2 years after ILC. MATERIAL & METHODS: A total of 134 patients (mean 71 year old) who underwent interstitial laser coagulation using Indigo830j (Ethicon Endo-Surgery) between 2000 and 2003 were investigated. The number of sticks was determined according patient's prostate volume (PV). The outcome measures were International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax) and quality-of-life (QOL) indexes and sexual function. Measurements were taken at baseline and at 1, 3, 6 months, and every 6 months after that. The relationship between treatment failure (second surgical interventions) and preoperative factors (age, PV, IPSS, Qmax and the obstruction grading of Schiller) were accessed. RESULTS: Median of preoperative PV, Qmax and IPSS were 4 lml, 7.35ml/sec and 19, respectively. Overall, an improvement of Qmax and IPSS was observed until 6 and 3 months after ILC, and gradually returned after then. QOL index decreased until 3 months after ILC and almost stable thereafter. No change in sexual function was observed. Seventeen cases (12.7%) needed second surgical interventions (TUR-P: 11 cases, re-ILCP: 2 cases, Open prostateetomy: 1 case, others: 3 cases) because their subjective or objective symptoms returned to the preoperative level. The median period to the re-treatment was 474 days (0-i463). Cox regression analysis indicated that smaller PV (<41ml) and severe obstruction (Sehfifer grade >3) are associated treatment failure (Table). Variables Age
Qmax PV Schiller Grade
C O N C L U S I O N S : The high-power 80W KTP laser is a promising modality in the surgical treatment of large prostate glands with minimal morbidity. This technique threatens to assign the open prostatectomy to the history books and certainly offers a safe surgical option for selected patients with very large prostates previously deemed medically unfit for open surgery.
European Urology Supplements 4 (2005) No. 3, pp. 256
IPSS
_>72 <72 >7.3ml/sec <7.3 ->41ml <41 _<3 >3 <19 >19
H.R.
95% C.I.
p values
1.97
0.73--5.30
0.18
1.31
0.46--3.71
0.61
3.01
0.98~9.21
0.05
11.1
1.25--100
0.03
1.18
0.36--2.86
0.76
CONCLUSIONS: The durability of Cojective effect after ILC was limited in a part of patients. Our results suggested that patients with small prostate (who might have bladder neck obstruction) or severe obstruction were not good candidates for ILC.