Purpose: To compare the perioperative and postoperative outcomes between traditional trans-vesical robot-assisted simple prostatectomy (TV-RASP) and the newly introduced urethral-sparing (US) RASP. Materials and Methods: We retrospectively reviewed 42 patients who underwent TV-RASP (n=22) or US-RASP (n=20) performed by two experienced surgeons at two tertiary centers. Perioperative outcomes including operation time, estimated blood loss, length of hospital stay, and catheterization time were assessed. Postoperative outcomes were evaluated using the International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, Male Sexual Health Questionnaire-Ejaculation Dysfunction-Short Form (MSHQ-EjD-SF) scores, and maintenance of anterograde ejaculation. Results: This study analyzed 22 and 20 patients who underwent TV-RASP and US-RASP, respectively. Except for the TV-RASP group being older (70.0 years) than the US-RASP group (64.5 years) (p=0.028), no differences among other baseline characteristics existed. Perioperative outcomes indicated that hospital stay and catheterization time were significantly shorter in the US-RASP group than in the TV-RASP group (p<0.001). At postoperative month 1, the median IPSS and QoL scores were significantly better in the US-RASP group than in the TV-RASP group (p=0.001 and p=0.002, respectively). However, at months 6 and 12, no significant differences were noted in IPSS, QoL, maximum flow rate, and postvoid residual urine between the two groups. Sexually active patients in the US-RASP group maintained postoperative MSHQ-EjD functional and bother scores, whereas the TV-RASP group experienced a decline. Notably, 75.0% of patients in the US-RASP group preserved antegrade ejaculation, compared to only 20.0% in the TV-RASP group (p<0.001). Conclusions US-RASP is not inferior to TV-RASP in terms of functional outcomes. In addition, US-RASP yielded more rapid symptom improvements and preserved antegrade ejaculation than TV-RASP. However, larger prospective studies are required to confirm these findings and to further investigate the long-term efficacy and safety of US-RASP.

Background and Objectives: The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea. Methods: A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography).The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D. Results: From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis. Conclusions Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

Purpose: To compare the perioperative and postoperative outcomes between traditional trans-vesical robot-assisted simple prostatectomy (TV-RASP) and the newly introduced urethral-sparing (US) RASP. Materials and Methods: We retrospectively reviewed 42 patients who underwent TV-RASP (n=22) or US-RASP (n=20) performed by two experienced surgeons at two tertiary centers. Perioperative outcomes including operation time, estimated blood loss, length of hospital stay, and catheterization time were assessed. Postoperative outcomes were evaluated using the International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, Male Sexual Health Questionnaire-Ejaculation Dysfunction-Short Form (MSHQ-EjD-SF) scores, and maintenance of anterograde ejaculation. Results: This study analyzed 22 and 20 patients who underwent TV-RASP and US-RASP, respectively. Except for the TV-RASP group being older (70.0 years) than the US-RASP group (64.5 years) (p=0.028), no differences among other baseline characteristics existed. Perioperative outcomes indicated that hospital stay and catheterization time were significantly shorter in the US-RASP group than in the TV-RASP group (p<0.001). At postoperative month 1, the median IPSS and QoL scores were significantly better in the US-RASP group than in the TV-RASP group (p=0.001 and p=0.002, respectively). However, at months 6 and 12, no significant differences were noted in IPSS, QoL, maximum flow rate, and postvoid residual urine between the two groups. Sexually active patients in the US-RASP group maintained postoperative MSHQ-EjD functional and bother scores, whereas the TV-RASP group experienced a decline. Notably, 75.0% of patients in the US-RASP group preserved antegrade ejaculation, compared to only 20.0% in the TV-RASP group (p<0.001). Conclusions US-RASP is not inferior to TV-RASP in terms of functional outcomes. In addition, US-RASP yielded more rapid symptom improvements and preserved antegrade ejaculation than TV-RASP. However, larger prospective studies are required to confirm these findings and to further investigate the long-term efficacy and safety of US-RASP.

Purpose: To compare the perioperative and postoperative outcomes between traditional trans-vesical robot-assisted simple prostatectomy (TV-RASP) and the newly introduced urethral-sparing (US) RASP. Materials and Methods: We retrospectively reviewed 42 patients who underwent TV-RASP (n=22) or US-RASP (n=20) performed by two experienced surgeons at two tertiary centers. Perioperative outcomes including operation time, estimated blood loss, length of hospital stay, and catheterization time were assessed. Postoperative outcomes were evaluated using the International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, Male Sexual Health Questionnaire-Ejaculation Dysfunction-Short Form (MSHQ-EjD-SF) scores, and maintenance of anterograde ejaculation. Results: This study analyzed 22 and 20 patients who underwent TV-RASP and US-RASP, respectively. Except for the TV-RASP group being older (70.0 years) than the US-RASP group (64.5 years) (p=0.028), no differences among other baseline characteristics existed. Perioperative outcomes indicated that hospital stay and catheterization time were significantly shorter in the US-RASP group than in the TV-RASP group (p<0.001). At postoperative month 1, the median IPSS and QoL scores were significantly better in the US-RASP group than in the TV-RASP group (p=0.001 and p=0.002, respectively). However, at months 6 and 12, no significant differences were noted in IPSS, QoL, maximum flow rate, and postvoid residual urine between the two groups. Sexually active patients in the US-RASP group maintained postoperative MSHQ-EjD functional and bother scores, whereas the TV-RASP group experienced a decline. Notably, 75.0% of patients in the US-RASP group preserved antegrade ejaculation, compared to only 20.0% in the TV-RASP group (p<0.001). Conclusions US-RASP is not inferior to TV-RASP in terms of functional outcomes. In addition, US-RASP yielded more rapid symptom improvements and preserved antegrade ejaculation than TV-RASP. However, larger prospective studies are required to confirm these findings and to further investigate the long-term efficacy and safety of US-RASP.

Background and Objectives: The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea. Methods: A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography).The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D. Results: From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis. Conclusions Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

Background and Objectives: The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea. Methods: A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography).The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D. Results: From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis. Conclusions Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

Purpose: To compare the perioperative and postoperative outcomes between traditional trans-vesical robot-assisted simple prostatectomy (TV-RASP) and the newly introduced urethral-sparing (US) RASP. Materials and Methods: We retrospectively reviewed 42 patients who underwent TV-RASP (n=22) or US-RASP (n=20) performed by two experienced surgeons at two tertiary centers. Perioperative outcomes including operation time, estimated blood loss, length of hospital stay, and catheterization time were assessed. Postoperative outcomes were evaluated using the International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, Male Sexual Health Questionnaire-Ejaculation Dysfunction-Short Form (MSHQ-EjD-SF) scores, and maintenance of anterograde ejaculation. Results: This study analyzed 22 and 20 patients who underwent TV-RASP and US-RASP, respectively. Except for the TV-RASP group being older (70.0 years) than the US-RASP group (64.5 years) (p=0.028), no differences among other baseline characteristics existed. Perioperative outcomes indicated that hospital stay and catheterization time were significantly shorter in the US-RASP group than in the TV-RASP group (p<0.001). At postoperative month 1, the median IPSS and QoL scores were significantly better in the US-RASP group than in the TV-RASP group (p=0.001 and p=0.002, respectively). However, at months 6 and 12, no significant differences were noted in IPSS, QoL, maximum flow rate, and postvoid residual urine between the two groups. Sexually active patients in the US-RASP group maintained postoperative MSHQ-EjD functional and bother scores, whereas the TV-RASP group experienced a decline. Notably, 75.0% of patients in the US-RASP group preserved antegrade ejaculation, compared to only 20.0% in the TV-RASP group (p<0.001). Conclusions US-RASP is not inferior to TV-RASP in terms of functional outcomes. In addition, US-RASP yielded more rapid symptom improvements and preserved antegrade ejaculation than TV-RASP. However, larger prospective studies are required to confirm these findings and to further investigate the long-term efficacy and safety of US-RASP.

Background and Objectives: The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea. Methods: A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography).The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D. Results: From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis. Conclusions Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

Purpose: To compare the perioperative and postoperative outcomes between traditional trans-vesical robot-assisted simple prostatectomy (TV-RASP) and the newly introduced urethral-sparing (US) RASP. Materials and Methods: We retrospectively reviewed 42 patients who underwent TV-RASP (n=22) or US-RASP (n=20) performed by two experienced surgeons at two tertiary centers. Perioperative outcomes including operation time, estimated blood loss, length of hospital stay, and catheterization time were assessed. Postoperative outcomes were evaluated using the International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, Male Sexual Health Questionnaire-Ejaculation Dysfunction-Short Form (MSHQ-EjD-SF) scores, and maintenance of anterograde ejaculation. Results: This study analyzed 22 and 20 patients who underwent TV-RASP and US-RASP, respectively. Except for the TV-RASP group being older (70.0 years) than the US-RASP group (64.5 years) (p=0.028), no differences among other baseline characteristics existed. Perioperative outcomes indicated that hospital stay and catheterization time were significantly shorter in the US-RASP group than in the TV-RASP group (p<0.001). At postoperative month 1, the median IPSS and QoL scores were significantly better in the US-RASP group than in the TV-RASP group (p=0.001 and p=0.002, respectively). However, at months 6 and 12, no significant differences were noted in IPSS, QoL, maximum flow rate, and postvoid residual urine between the two groups. Sexually active patients in the US-RASP group maintained postoperative MSHQ-EjD functional and bother scores, whereas the TV-RASP group experienced a decline. Notably, 75.0% of patients in the US-RASP group preserved antegrade ejaculation, compared to only 20.0% in the TV-RASP group (p<0.001). Conclusions US-RASP is not inferior to TV-RASP in terms of functional outcomes. In addition, US-RASP yielded more rapid symptom improvements and preserved antegrade ejaculation than TV-RASP. However, larger prospective studies are required to confirm these findings and to further investigate the long-term efficacy and safety of US-RASP.

Objective: This study aimed to determine the safety and efficacy of the RKP00156 vaginal tablet, a CDK9 inhibitor, in healthy women and patients with cervical intraepithelial neoplasia grade 2 (CIN2). Methods: We conducted a phase 1/2a clinical trial of RKP00156. In step 1, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered transvaginally to 24 healthy women.In step 2, RKP00156 at a dose of 10, 25, or 50 mg or a placebo tablet was administered once daily for 4 weeks in 62 patients with CIN2. The primary endpoints of this trial were the safety of RKP00156 and the change in the human papillomavirus (HPV) viral load. Results: A total of 86 patients were enrolled and randomized. RKP00156 administration did not cause serious drug-associated adverse events (AEs). Although no significant difference in the HPV viral load was found between the experimental and placebo groups, a reduction in the HPV viral load was observed in the 25 mg-dose group (−98.61%; 95% confidence interval=−99.83%, 4.52%; p=0.046) after treatment completion in patients with a high HPV viral load, despite a lack of statistical power. No differences in histologic regression and HPV clearance were observed. Conclusion The safety of RKP00156 was proved with no serious AEs. Although the study did not show any significance in histologic regression and HPV clearance, our findings indicate that RKP00156 may have a possibility of short-term inhibitory effect on HPV replication in patients with higher viral loads.