Pub Date : 2020-04-01DOI: 10.1097/ju.0000000000000931
Connelly Miller, Thomas Monaghan, Elaine Redmond, Chris Doiron, Keith Rourke, Elizabeth I. Roger, K. McCammon
INTRODUCTION AND OBJECTIVE: Vibegron (VIB) is a novel, oral, once-daily b3-adrenergic receptor agonist being investigated for OAB treatment. In the phase 3 randomized, double-blind, 12-week EMPOWUR trial (N[1518), VIB 75 mg statistically significantly improved primary OAB endpoints of daily micturitions and urge urinary incontinence (UUI) (P<0.001 each) and key secondary endpoints vs placebo; tolterodine (TOL) extended-release 4 mg was active control. VIB tolerability was favorable. Results from the 40week EMPOWUR extension are reported. METHODS: EMPOWUR enrolled adults aged 18 years with OAB wet (incontinence) or dry. The 40-week extension enrolled w500 EMPOWUR completers. Those receiving VIB or TOL in EMPOWUR continued; placebo patients (pts) received VIB or TOL (1:1). The primary endpoint was VIB safety and tolerability. Key efficacy endpoints were changes from EMPOWUR baseline at week 52 in average daily micturitions, UUI, urgency, and total urinary incontinence (TUI). RESULTS: Among 505 randomized, treated extension pts (n [273, VIB; n[232, TOL), mean age was 61.1 years; 46.5% were aged 65 years; 78.2% were women; and 78.2% had OAB wet. Baseline characteristics and extension completion rates (VIB, 85.8%; TOL, 84.1%) were similar. AEs occurred in 62.6% of VIB and 54.3% of TOL pts; 4 (1.5%) VIB and 8 (3.4%) TOL pts discontinued study medication due to an AE. Key AEs (>5% for VIB) for VIB and TOL, respectively, were hypertension (8.8% and 8.6%), urinary tract infection (6.6% and 7.3%), and headache (5.5% and 3.9%). One death (due to arteriosclerotic disease, judged not related to study drug by investigators or sponsor) occurred in the VIB group. Among pts receiving 52 weeks of active treatment, there was further improvement from week 12 to 52 in all key OAB endpoints: micturitions and UUI episodes (Figure), urgency (-3.4, VIB [n[176]; -3.2, TOL [n[136]), and TUI (-2.5, VIB [n[143]; -1.9, TOL [n[106]); 61% of VIB-treated pts had a 75% reduction in UUI, and 41% had a 100% reduction (ie, were dry) at week 52. CONCLUSIONS: Consistent with the placebo-controlled EMPOWUR phase 3 study, vibegron demonstrated a favorable longterm safety profile in pts with OAB. Vibegron-treated pts had further improvement in micturitions, UUI, urgency, TUI; 41% with no UUI episodes at week 52. Source of Funding: Urovant Sciences
{"title":"Urodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine","authors":"Connelly Miller, Thomas Monaghan, Elaine Redmond, Chris Doiron, Keith Rourke, Elizabeth I. Roger, K. McCammon","doi":"10.1097/ju.0000000000000931","DOIUrl":"https://doi.org/10.1097/ju.0000000000000931","url":null,"abstract":"INTRODUCTION AND OBJECTIVE: Vibegron (VIB) is a novel, oral, once-daily b3-adrenergic receptor agonist being investigated for OAB treatment. In the phase 3 randomized, double-blind, 12-week EMPOWUR trial (N[1518), VIB 75 mg statistically significantly improved primary OAB endpoints of daily micturitions and urge urinary incontinence (UUI) (P<0.001 each) and key secondary endpoints vs placebo; tolterodine (TOL) extended-release 4 mg was active control. VIB tolerability was favorable. Results from the 40week EMPOWUR extension are reported. METHODS: EMPOWUR enrolled adults aged 18 years with OAB wet (incontinence) or dry. The 40-week extension enrolled w500 EMPOWUR completers. Those receiving VIB or TOL in EMPOWUR continued; placebo patients (pts) received VIB or TOL (1:1). The primary endpoint was VIB safety and tolerability. Key efficacy endpoints were changes from EMPOWUR baseline at week 52 in average daily micturitions, UUI, urgency, and total urinary incontinence (TUI). RESULTS: Among 505 randomized, treated extension pts (n [273, VIB; n[232, TOL), mean age was 61.1 years; 46.5% were aged 65 years; 78.2% were women; and 78.2% had OAB wet. Baseline characteristics and extension completion rates (VIB, 85.8%; TOL, 84.1%) were similar. AEs occurred in 62.6% of VIB and 54.3% of TOL pts; 4 (1.5%) VIB and 8 (3.4%) TOL pts discontinued study medication due to an AE. Key AEs (>5% for VIB) for VIB and TOL, respectively, were hypertension (8.8% and 8.6%), urinary tract infection (6.6% and 7.3%), and headache (5.5% and 3.9%). One death (due to arteriosclerotic disease, judged not related to study drug by investigators or sponsor) occurred in the VIB group. Among pts receiving 52 weeks of active treatment, there was further improvement from week 12 to 52 in all key OAB endpoints: micturitions and UUI episodes (Figure), urgency (-3.4, VIB [n[176]; -3.2, TOL [n[136]), and TUI (-2.5, VIB [n[143]; -1.9, TOL [n[106]); 61% of VIB-treated pts had a 75% reduction in UUI, and 41% had a 100% reduction (ie, were dry) at week 52. CONCLUSIONS: Consistent with the placebo-controlled EMPOWUR phase 3 study, vibegron demonstrated a favorable longterm safety profile in pts with OAB. Vibegron-treated pts had further improvement in micturitions, UUI, urgency, TUI; 41% with no UUI episodes at week 52. Source of Funding: Urovant Sciences","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":" December","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141219142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-04-01DOI: 10.1097/ju.0000000000000938
Arun Chawla
INTRODUCTION AND OBJECTIVE: RIRS is useful in the management of small renal calculi (<2cm), however in developing countries PCNL provides alternative which is economical and provides stone clearance in single stage. Miniaturized PCNL are associated with lesser complications compared to standard PCNL. But concerns in the miniaturized PCNL remains about stone clearance. To address this concern, the current miniPCNL that is Super-mini PCNL (SMP) was designed for effective stone clearance with fragments removal by irrigation/suction and fragment extraction by smaller stone removal forceps and with added advantage to prevent excessive intrarenal pressure and improved visualization. There is lacunae of data comparing the results of this Super mini PCNL procedure with standard PCNL. In the present study, the primary objective is to compare the efficacy (stone-free rate) between SMP and standard PCNL. The secondary objectives are to compare the safety (blood loss, complications), operative time, length of hospital stay and post-operative pain score and analgesic requirement. METHODS: 150 patients presenting with renal calculi < 2 cm were randomized to a standard or a Super-mini PCNL group between September 2018 and April 2019. Randomization was based on centralized computer-generated numbers. In SMP, sheath is of 14-Fr size with internal working channel of 12.5 Fr and an oblique channel to which suction was attached. This oblique part consists of a pressure vent through which pressure can be adjusted by either partially or completely occluding the pressure vent with the surgeon's thumb. Irrigation into pelvi-calyceal system is through a 6 Fr ureteric catheter (with multiple holes at the proximal 5 cm) placed in the ureter. With active suction, the dust and tiny stone fragments would pass through the oblique channel into the collecting bottle of suction. The larger fragments were extracted using a 3Fr grasper. In standard PCNL, 24-28 Fr amplatz sheath and 20.8 / 26 Fr nephroscope were used to manage the calculus. Variables studied were stone free rates, operating time, intraoperative and postoperative complications (according to the ClavieneDindo classification system), postoperative pain score, analgesic requirement and hospital stay. Statistical analysis was performed using a t-test for continuous variables with normal distribution and a ManneWhitney U-test for variables without normal distribution. For categorical variables, the chi-squared test or Fisher's exact test was applied. A P value <0.05 was considered to indicate statistical significance. RESULTS: Comparison of intra-operative and postoperative variables in the two study groups. CONCLUSIONS: Super-mini PCNL offers equal stone clearance rate compared to standard PCNL, however it is more safe when compared to standard PCNL in-terms of complications. Even though SMP has more operative time compared to standard PCNL, it has significantly less intra-operative and post-operative bleeding with less
{"title":"Stone Disease","authors":"Arun Chawla","doi":"10.1097/ju.0000000000000938","DOIUrl":"https://doi.org/10.1097/ju.0000000000000938","url":null,"abstract":"INTRODUCTION AND OBJECTIVE: RIRS is useful in the management of small renal calculi (<2cm), however in developing countries PCNL provides alternative which is economical and provides stone clearance in single stage. Miniaturized PCNL are associated with lesser complications compared to standard PCNL. But concerns in the miniaturized PCNL remains about stone clearance. To address this concern, the current miniPCNL that is Super-mini PCNL (SMP) was designed for effective stone clearance with fragments removal by irrigation/suction and fragment extraction by smaller stone removal forceps and with added advantage to prevent excessive intrarenal pressure and improved visualization. There is lacunae of data comparing the results of this Super mini PCNL procedure with standard PCNL. In the present study, the primary objective is to compare the efficacy (stone-free rate) between SMP and standard PCNL. The secondary objectives are to compare the safety (blood loss, complications), operative time, length of hospital stay and post-operative pain score and analgesic requirement. METHODS: 150 patients presenting with renal calculi < 2 cm were randomized to a standard or a Super-mini PCNL group between September 2018 and April 2019. Randomization was based on centralized computer-generated numbers. In SMP, sheath is of 14-Fr size with internal working channel of 12.5 Fr and an oblique channel to which suction was attached. This oblique part consists of a pressure vent through which pressure can be adjusted by either partially or completely occluding the pressure vent with the surgeon's thumb. Irrigation into pelvi-calyceal system is through a 6 Fr ureteric catheter (with multiple holes at the proximal 5 cm) placed in the ureter. With active suction, the dust and tiny stone fragments would pass through the oblique channel into the collecting bottle of suction. The larger fragments were extracted using a 3Fr grasper. In standard PCNL, 24-28 Fr amplatz sheath and 20.8 / 26 Fr nephroscope were used to manage the calculus. Variables studied were stone free rates, operating time, intraoperative and postoperative complications (according to the ClavieneDindo classification system), postoperative pain score, analgesic requirement and hospital stay. Statistical analysis was performed using a t-test for continuous variables with normal distribution and a ManneWhitney U-test for variables without normal distribution. For categorical variables, the chi-squared test or Fisher's exact test was applied. A P value <0.05 was considered to indicate statistical significance. RESULTS: Comparison of intra-operative and postoperative variables in the two study groups. CONCLUSIONS: Super-mini PCNL offers equal stone clearance rate compared to standard PCNL, however it is more safe when compared to standard PCNL in-terms of complications. Even though SMP has more operative time compared to standard PCNL, it has significantly less intra-operative and post-operative bleeding with less ","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"121 17","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141217491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-04-01DOI: 10.1097/ju.0000000000000927
Jae Duck Choi, Kyong Tae Moon
INTRODUCTION AND OBJECTIVE: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was known to be closely related with erectile dysfunction (ED). However, studies were insufficient and the results are inconsistent. We assessed the relationship between chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and erectile dysfunction (ED) using propensity score matching. METHODS: From 2011 to 2013, data from 8727 male in their 40s and 50s who had participated in a health checkup were analyzed. The National Institutes of Health-Chronic Prostatitis Symptoms Index (NIH-CPSI), International Index of Erectile Function-5 (IIEF), Premature Ejaculation Diagnostic Tool (PEDT), testosterone, basic blood chemistry, and metabolic syndrome (MetS) assessment were used for this study. Symptoms were classified as a ‘no' if respondents reported no perineal or ejaculatory pain or had a NIH-CPSI pain score of <4; the symptoms were classified as ‘moderate to severe' if the pain score was >7 according to a previous study. Of these, 7181 formed the cohort for propensity score matching, including 597 men with moderate to severe prostatitis-like symptom (case) and 6584 men with no prostatitis-like symptom (control), however, ultimately, propensity scores were matched at 1:1 ratio of controls to case group (597 men in control group and 597 men in case group). RESULTS: After propensity score matching, age and PEDT variables which was found to be significantly different before propensity score matching were evenly dispersed and did not differ significantly between the groups (Table 1). After matching, the mean IIEF score of case group was significantly lower than control group (IIEF: 17.2 5.5 vs. 14.7 5.3; P<0.001). Additionally, ED severity was significantly greater in case group (no, mild, mild to moderate, moderate, and severe ED: 27.5%, 30.2%, 24.6%, 13.1%, and 4.7% in control group, 10.7%, 27.0%, 33.0%, 18.9%, and 10.4% in case group; P<0.001). Finally, the rate of moderate to severe ED was significantly higher in case group (17.8% vs. 29.3%; P<0.001). CONCLUSIONS: Presence of moderate to severe prostatitislike symptom was significantly and independently correlated with ED.
{"title":"Infections/Inflammation/Cystic Disease of the Genitourinary Tract","authors":"Jae Duck Choi, Kyong Tae Moon","doi":"10.1097/ju.0000000000000927","DOIUrl":"https://doi.org/10.1097/ju.0000000000000927","url":null,"abstract":"INTRODUCTION AND OBJECTIVE: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was known to be closely related with erectile dysfunction (ED). However, studies were insufficient and the results are inconsistent. We assessed the relationship between chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and erectile dysfunction (ED) using propensity score matching. METHODS: From 2011 to 2013, data from 8727 male in their 40s and 50s who had participated in a health checkup were analyzed. The National Institutes of Health-Chronic Prostatitis Symptoms Index (NIH-CPSI), International Index of Erectile Function-5 (IIEF), Premature Ejaculation Diagnostic Tool (PEDT), testosterone, basic blood chemistry, and metabolic syndrome (MetS) assessment were used for this study. Symptoms were classified as a ‘no' if respondents reported no perineal or ejaculatory pain or had a NIH-CPSI pain score of <4; the symptoms were classified as ‘moderate to severe' if the pain score was >7 according to a previous study. Of these, 7181 formed the cohort for propensity score matching, including 597 men with moderate to severe prostatitis-like symptom (case) and 6584 men with no prostatitis-like symptom (control), however, ultimately, propensity scores were matched at 1:1 ratio of controls to case group (597 men in control group and 597 men in case group). RESULTS: After propensity score matching, age and PEDT variables which was found to be significantly different before propensity score matching were evenly dispersed and did not differ significantly between the groups (Table 1). After matching, the mean IIEF score of case group was significantly lower than control group (IIEF: 17.2 5.5 vs. 14.7 5.3; P<0.001). Additionally, ED severity was significantly greater in case group (no, mild, mild to moderate, moderate, and severe ED: 27.5%, 30.2%, 24.6%, 13.1%, and 4.7% in control group, 10.7%, 27.0%, 33.0%, 18.9%, and 10.4% in case group; P<0.001). Finally, the rate of moderate to severe ED was significantly higher in case group (17.8% vs. 29.3%; P<0.001). CONCLUSIONS: Presence of moderate to severe prostatitislike symptom was significantly and independently correlated with ED.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":" 938","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141218183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-01DOI: 10.1097/JU.0000000000000631
F. Montorsi, M. Moschini, A. Gallina, A. Briganti, A. Necchi
{"title":"Re: Ten-Year Oncologic Outcomes Following Robot-Assisted Radical Cystectomy: Results from the International Robotic Cystectomy Consortium.","authors":"F. Montorsi, M. Moschini, A. Gallina, A. Briganti, A. Necchi","doi":"10.1097/JU.0000000000000631","DOIUrl":"https://doi.org/10.1097/JU.0000000000000631","url":null,"abstract":"","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"23 12","pages":"101097JU0000000000000631"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141227254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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