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PD-02.09
PODIUM SESSIONS
Table 1. PD-02.08 Placebo 6 wks N* 143 IPSS† ⫺1.2⫾0.47 ⫺0.2⫾0.11 IPSS QoL† BII† ⫺0.4⫾0.21 LUTS GAQ, endpt, % Yes 32.6
Tadalafil 5 mg 6 wks 138 ⫺2.8⫾0.48 ⫺0.5⫾0.11 ⫺0.7⫾0.22 55.9
0.003 0.017 0.107
Placebo 12 wks 143 ⫺1.7⫾0.49 ⫺0.3⫾0.12 ⫺0.6⫾0.23
Tadalafil 5/20 mg 12 wks 138 ⫺3.8⫾0.50 ⫺0.7⫾0.12 ⫺1.3⫾0.23
⬍0.001 0.008 0.008
⬍0.001
37.7
57.4
⬍0.001
P value
P value
* Number of subjects randomly assigned † Change from baseline, LS Mean⫾SE
tad 5 mg vs 0% pbo; 3.6% tad 5/20 mg vs 1.4% pbo). Conclusions: Tadalafil dosed once a day was well-tolerated and demonstrated clinically meaningful and statistically significant efficacy in the treatment of LUTS secondary to BPH and improved erectile function in the subset of men with both LUTS and ED. Funded by Lilly ICOS LLC PD-02.09 Finasteride alone maintains stable urinary symptoms (ipss) in men with benign prostatic hyperplasia after 9 months of combination therapy using an alpha-blocker and finasteride. Elhilali M1, Dupont C2, Koch C3, on behalf of the PROACT study centers 1 McGill University, Montreal, Canada; 2 Datamed Inc., Montreal, Canada; 3 Merck Frosst Canada Ltd., Canada Introduction: Once combination therapy using an alpha-blocker and finasteride has been started, it may not be necessary to continue alpha-blockade indefinitely. This Canadian multicenter study evaluated the efficacy of combining finasteride and an alpha-blocker followed by finasteride monotherapy on symptom improvement in patients with moderate benign prostatic hyperplasia (BPH) in a “real-life” setting. Methods: This “equivalence design” study tested the maintenance of therapeutic effect with 3 months of finasteride alone after 9-months’ combination therapy using finasteride with an alpha-blocker. Equivalence was defined as a change of ⱕ 2.0 IPSS points. Results: 275 males, 66.1 ⫾ 7.7 years old, diagnosed with BPH, having an IPSS ⬎ 12 and an enlarged prostate, were enrolled from April 2004 until May 2005. Baseline IPSS was 20.3⫾5.4 and IPSS-Quality of Life (QoL) was 3.9⫾1.3. 173 subjects (63%) completed study per-
8
protocol; 85 (31%) discontinued, mainly for Non Serious Adverse Events (NSAE) (67.1%); 9 (3%) were lost to follow-up; and, 8 (3%) subjects were protocol violators. As the primary endpoint was the comparison of 3-months’ monotherapy to 9-months’ combination therapy, only subjects who completed per-protocol are included. Final results show that IPSS significantly decreased after 9-months’ combination therapy compared to baseline (19.9⫾5.1 to 12.0⫾6.0; p⬍0.0001); IPSS-QoL component improved from 3.8⫾1.2 to 2.4⫾1.3 (p⬍0.0001) and PSA decreased from 3.5⫾2.2 to 2.0⫾1.4 ng/mL (p⬍0.0001). Change of IPSS at end of monotherapy compared to end of combination therapy was within equivalence criterion (mean 1.26, 95%CI 0.58-1.94; p⫽0.036). PSA also remained stable (p⫽0.542). The QoL score increased slightly from 2.38⫾1.2 to 2.62⫾1.36 (p⫽0.008). A total of 324 NSAEs occurred in 142 subjects (total mean ⫽ 1.2⫾1.6), 66.1% of all NSAE started during the combination therapy, 28.8% leading to discontinuation. Of all NSAEs, 37.2% were “urinary/ sexual”. 25 SAEs occurred and 88.0% were considered unrelated including the 4 reported deaths. Conclusion: The study results show that finasteride monotherapy for 3 months maintains the same urinary symptom relief obtained by 9-months combination therapy in BPH patients. Furthermore, the ongoing 6-month extension study with finasteride monotherapy will enable us to assess if the effect is maintained over a total of 9-months.
PD-02.10 Day surgery transurethral resection of prostate: our initial experience Chua WJ, Tibung MJB, Consigliere D Department of Urology, National University Hospital, Singapore
Introduction: The current gold standard surgical treatment for Benign Prostate Hypertrophy (BPH) is transurethral resection of prostate (TURP), using a monopolar loop electrode for resection. We aim to convert this in-patient procedure (average 3.5 days’ stay) into a day surgery procedure using a new energy source – Plasmakinetic bipolar. Methods: All ASA 1and 2 patients, age 80 and below, with significantly obstructed BPH requiring surgical intervention, from a single institute (NUH) were recruited in this study. TURP were done using the Gyrus Superpulse Plasmakinetic bipolar loop electrode. Post-op, patients were placed on continuous bladder irrigation for 4-6 hours and were observed. Stable patients with no gross haematuria were discharged and return two days later for removal of catheter. Results: 35 patients have been recruited to date. Mean resection time, resected weight and duration of bladder washout are 42mins, 17.5g and 5.9hrs respectively. Surgeries were uneventful except for one patient in whom an inadvertent undermining of bladder neck occurred. None of the patients required blood transfusion. 32 patients were discharged on the same day. There was no case of unexpected admission. 31 patients had their catheter successfully removed on 2nd POD. As with standard TURP, there is an immediate improvement in urinary flow with corresponding reduction in lower urinary tract symptoms following surgery. There were 5 cases of urethral strictures noted on follow-up. On the whole, patients are happy to have this procedure done as a day case. Cost benefit analysis showed saving compared to standard TURP. Conclusion: Our initial experience has shown that it is feasible and safe to perform TURP as a day case. To patient, it reduces hospitalization fee, length of stay and morbidity. To hospital, it frees up beds for acute admission. We hope that successful implementation will reduce heath care cost without compromising quality care and service to our patients. PD-02.11 Cetrorelix pamoate, an LHRH antagonist, in the treatment of BPH: randomized, placebo-controlled multicenter study Debruyne FMJ1, Tzvetkov M2, Medverec Z3, Altarac S4, Peukert M5, Engel J5 1 Department of Urology, University Medical Center, Nijmegen, The Netherlands;
UROLOGY 68 (Supplement 5A), November 2006
Table 1. PD-02.08 Placebo 6 wks N* 143 IPSS† ⫺1.2⫾0.47 ⫺0.2⫾0.11 IPSS QoL† BII† ⫺0.4⫾0.21 LUTS GAQ, endpt, % Yes 32.6
Tadalafil 5 mg 6 wks 138 ⫺2.8⫾0.48 ⫺0.5⫾0.11 ⫺0.7⫾0.22 55.9
0.003 0.017 0.107
Placebo 12 wks 143 ⫺1.7⫾0.49 ⫺0.3⫾0.12 ⫺0.6⫾0.23
Tadalafil 5/20 mg 12 wks 138 ⫺3.8⫾0.50 ⫺0.7⫾0.12 ⫺1.3⫾0.23
⬍0.001 0.008 0.008
⬍0.001
37.7
57.4
⬍0.001
P value
P value
* Number of subjects randomly assigned † Change from baseline, LS Mean⫾SE
tad 5 mg vs 0% pbo; 3.6% tad 5/20 mg vs 1.4% pbo). Conclusions: Tadalafil dosed once a day was well-tolerated and demonstrated clinically meaningful and statistically significant efficacy in the treatment of LUTS secondary to BPH and improved erectile function in the subset of men with both LUTS and ED. Funded by Lilly ICOS LLC PD-02.09 Finasteride alone maintains stable urinary symptoms (ipss) in men with benign prostatic hyperplasia after 9 months of combination therapy using an alpha-blocker and finasteride. Elhilali M1, Dupont C2, Koch C3, on behalf of the PROACT study centers 1 McGill University, Montreal, Canada; 2 Datamed Inc., Montreal, Canada; 3 Merck Frosst Canada Ltd., Canada Introduction: Once combination therapy using an alpha-blocker and finasteride has been started, it may not be necessary to continue alpha-blockade indefinitely. This Canadian multicenter study evaluated the efficacy of combining finasteride and an alpha-blocker followed by finasteride monotherapy on symptom improvement in patients with moderate benign prostatic hyperplasia (BPH) in a “real-life” setting. Methods: This “equivalence design” study tested the maintenance of therapeutic effect with 3 months of finasteride alone after 9-months’ combination therapy using finasteride with an alpha-blocker. Equivalence was defined as a change of ⱕ 2.0 IPSS points. Results: 275 males, 66.1 ⫾ 7.7 years old, diagnosed with BPH, having an IPSS ⬎ 12 and an enlarged prostate, were enrolled from April 2004 until May 2005. Baseline IPSS was 20.3⫾5.4 and IPSS-Quality of Life (QoL) was 3.9⫾1.3. 173 subjects (63%) completed study per-
8
protocol; 85 (31%) discontinued, mainly for Non Serious Adverse Events (NSAE) (67.1%); 9 (3%) were lost to follow-up; and, 8 (3%) subjects were protocol violators. As the primary endpoint was the comparison of 3-months’ monotherapy to 9-months’ combination therapy, only subjects who completed per-protocol are included. Final results show that IPSS significantly decreased after 9-months’ combination therapy compared to baseline (19.9⫾5.1 to 12.0⫾6.0; p⬍0.0001); IPSS-QoL component improved from 3.8⫾1.2 to 2.4⫾1.3 (p⬍0.0001) and PSA decreased from 3.5⫾2.2 to 2.0⫾1.4 ng/mL (p⬍0.0001). Change of IPSS at end of monotherapy compared to end of combination therapy was within equivalence criterion (mean 1.26, 95%CI 0.58-1.94; p⫽0.036). PSA also remained stable (p⫽0.542). The QoL score increased slightly from 2.38⫾1.2 to 2.62⫾1.36 (p⫽0.008). A total of 324 NSAEs occurred in 142 subjects (total mean ⫽ 1.2⫾1.6), 66.1% of all NSAE started during the combination therapy, 28.8% leading to discontinuation. Of all NSAEs, 37.2% were “urinary/ sexual”. 25 SAEs occurred and 88.0% were considered unrelated including the 4 reported deaths. Conclusion: The study results show that finasteride monotherapy for 3 months maintains the same urinary symptom relief obtained by 9-months combination therapy in BPH patients. Furthermore, the ongoing 6-month extension study with finasteride monotherapy will enable us to assess if the effect is maintained over a total of 9-months.
PD-02.10 Day surgery transurethral resection of prostate: our initial experience Chua WJ, Tibung MJB, Consigliere D Department of Urology, National University Hospital, Singapore
Introduction: The current gold standard surgical treatment for Benign Prostate Hypertrophy (BPH) is transurethral resection of prostate (TURP), using a monopolar loop electrode for resection. We aim to convert this in-patient procedure (average 3.5 days’ stay) into a day surgery procedure using a new energy source – Plasmakinetic bipolar. Methods: All ASA 1and 2 patients, age 80 and below, with significantly obstructed BPH requiring surgical intervention, from a single institute (NUH) were recruited in this study. TURP were done using the Gyrus Superpulse Plasmakinetic bipolar loop electrode. Post-op, patients were placed on continuous bladder irrigation for 4-6 hours and were observed. Stable patients with no gross haematuria were discharged and return two days later for removal of catheter. Results: 35 patients have been recruited to date. Mean resection time, resected weight and duration of bladder washout are 42mins, 17.5g and 5.9hrs respectively. Surgeries were uneventful except for one patient in whom an inadvertent undermining of bladder neck occurred. None of the patients required blood transfusion. 32 patients were discharged on the same day. There was no case of unexpected admission. 31 patients had their catheter successfully removed on 2nd POD. As with standard TURP, there is an immediate improvement in urinary flow with corresponding reduction in lower urinary tract symptoms following surgery. There were 5 cases of urethral strictures noted on follow-up. On the whole, patients are happy to have this procedure done as a day case. Cost benefit analysis showed saving compared to standard TURP. Conclusion: Our initial experience has shown that it is feasible and safe to perform TURP as a day case. To patient, it reduces hospitalization fee, length of stay and morbidity. To hospital, it frees up beds for acute admission. We hope that successful implementation will reduce heath care cost without compromising quality care and service to our patients. PD-02.11 Cetrorelix pamoate, an LHRH antagonist, in the treatment of BPH: randomized, placebo-controlled multicenter study Debruyne FMJ1, Tzvetkov M2, Medverec Z3, Altarac S4, Peukert M5, Engel J5 1 Department of Urology, University Medical Center, Nijmegen, The Netherlands;
UROLOGY 68 (Supplement 5A), November 2006