Pub Date : 2024-10-24DOI: 10.1097/ju.0000000000004296
Sandip M Prasad,Dimitar Shishkov,Nikola Vladimirov Mihaylov,Alexandre Khuskivadze,Pencho Genov,Vasyl Terzi,Max Kates,William C Huang,Michael J Louie,Sunil Raju,Brent Burger,Andrew Meads,Mark Schoenberg
PURPOSETo evaluate the efficacy and safety of UGN-102 chemoablation for the primary treatment of patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer.MATERIALS AND METHODSENVISION is an ongoing, multinational, single-arm, Phase 3 study in patients with a biopsy-proven recurrence of untreated low-grade intermediate-risk nonmuscle-invasive bladder cancer. Patients received 6 weekly intravesical instillations of UGN-102 (mitomycin; outpatient setting) and were evaluated at 3 months. Patients achieving complete response (CR) (negative cystoscopic examination, cytology, and for-cause biopsy) were surveilled regularly until recurrence, progression, or death. Patients who remain disease-free will be followed up to 5 years, and further results will be reported in the future.RESULTSOf 240 patients enrolled, 228 (95%) received all 6 planned doses; 191 (79.6%; 95% CI: 73.9, 84.5) achieved CR at 3 months, with an 82.3% (95% CI: 75.9, 87.1) probability of response 12 months later. Median duration of response was not estimable over a median 13.9-month follow-up period. The most common adverse events (≥5.0% of patients) were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention; generally mild/moderate and resolved/resolving. Serious adverse events were observed in 29/240 (12.1%), 2 were treatment-related (urinary retention/urethral stenosis), both resolved.CONCLUSIONSPrimary chemoablation with UGN-102 in patients with recurrent low-grade-intermediate-risk-nonmuscle-invasive bladder cancer resulted in a 79.6% CR rate. Patients achieving a CR had an 82.3% likelihood of remaining disease-free 1 year later. The benefit-risk profile was favorable, supporting UGN-102 as a non-surgical alternative for transurethral resection of bladder tumors in this patient population. Limitations of this study included lack of tumor sizing after the diagnostic biopsy.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT05243550.
{"title":"Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION).","authors":"Sandip M Prasad,Dimitar Shishkov,Nikola Vladimirov Mihaylov,Alexandre Khuskivadze,Pencho Genov,Vasyl Terzi,Max Kates,William C Huang,Michael J Louie,Sunil Raju,Brent Burger,Andrew Meads,Mark Schoenberg","doi":"10.1097/ju.0000000000004296","DOIUrl":"https://doi.org/10.1097/ju.0000000000004296","url":null,"abstract":"PURPOSETo evaluate the efficacy and safety of UGN-102 chemoablation for the primary treatment of patients with recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer.MATERIALS AND METHODSENVISION is an ongoing, multinational, single-arm, Phase 3 study in patients with a biopsy-proven recurrence of untreated low-grade intermediate-risk nonmuscle-invasive bladder cancer. Patients received 6 weekly intravesical instillations of UGN-102 (mitomycin; outpatient setting) and were evaluated at 3 months. Patients achieving complete response (CR) (negative cystoscopic examination, cytology, and for-cause biopsy) were surveilled regularly until recurrence, progression, or death. Patients who remain disease-free will be followed up to 5 years, and further results will be reported in the future.RESULTSOf 240 patients enrolled, 228 (95%) received all 6 planned doses; 191 (79.6%; 95% CI: 73.9, 84.5) achieved CR at 3 months, with an 82.3% (95% CI: 75.9, 87.1) probability of response 12 months later. Median duration of response was not estimable over a median 13.9-month follow-up period. The most common adverse events (≥5.0% of patients) were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention; generally mild/moderate and resolved/resolving. Serious adverse events were observed in 29/240 (12.1%), 2 were treatment-related (urinary retention/urethral stenosis), both resolved.CONCLUSIONSPrimary chemoablation with UGN-102 in patients with recurrent low-grade-intermediate-risk-nonmuscle-invasive bladder cancer resulted in a 79.6% CR rate. Patients achieving a CR had an 82.3% likelihood of remaining disease-free 1 year later. The benefit-risk profile was favorable, supporting UGN-102 as a non-surgical alternative for transurethral resection of bladder tumors in this patient population. Limitations of this study included lack of tumor sizing after the diagnostic biopsy.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT05243550.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"5 1","pages":"101097JU0000000000004296"},"PeriodicalIF":0.0,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142489343","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 : 2024-10-23DOI: 10.1097/ju.0000000000004291
David Staskin,Janet Owens-Grillo,Elizabeth Thomas,Eric Rovner
{"title":"Reply: Letter: Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 COURAGE Trial.","authors":"David Staskin,Janet Owens-Grillo,Elizabeth Thomas,Eric Rovner","doi":"10.1097/ju.0000000000004291","DOIUrl":"https://doi.org/10.1097/ju.0000000000004291","url":null,"abstract":"","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"1 1","pages":"101097JU0000000000004291"},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142488294","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 : 2024-10-18DOI: 10.1097/ju.0000000000004297
Tarek Benzouak,Abdulmalik Addar,Michael A Prudencio-Brunello,Ammar Saed Aldien,Steve E Amougou,Ahmad AlShammari,Mohammed Ramadhan,Serge Carrier,Mélanie Aubé-Peterkin,Fadl Hamouche
PURPOSEAs the prevalence of Benign Prostatic Hyperplasia (BPH) increases, the demand for surgical interventions that optimize patient outcomes while minimizing complications grows. This systematic review compares the efficacy, efficiency, and safety of Holmium Laser Enucleation of the Prostate (HoLEP) with Robotic-Assisted Simple Prostatectomy (RASP), providing insights for evidence-based surgical decision-making in BPH treatment.MATERIALS AND METHODSAdhering to PRISMA guidelines, the study protocol was registered with Prospero [CRD42024509627]. Searches were conducted in Medline, Embase, Web of Science, Scopus, and CINAHL up to February 1, 2024, to include studies that compare HoLEP and RASP in BPH patients. Risk of Bias was evaluated using the Newcastle Ottawa Scale.RESULTSHoLEP and RASP demonstrated equivalent effectiveness in treating BPH, as shown by similar functional outcomes like maximum urinary flow rate and post-void residual volume. However, HoLEP outperformed RASP in several operational efficiency metrics, reducing operative time by 49.48 minutes, hospitalization duration by 1.5 days, and catheterization period by 3.8 days. HoLEP also significantly reduced the risk of blood transfusions by 75%. Patients undergoing RASP were 1.87 times more at risk for grade 2 complications and 3.41 times more at risk for developing grade 3 or above complications.CONCLUSIONSHoLEP and RASP are effective for managing BPH. HoLEP shows advantages in recovery metrics and lower blood transfusion rates, while RASP benefits from ease of implementation in robotic-equipped facilities. Optimizing surgical outcomes will depend on reducing disparities in technique adoption, improving surgical training, and aligning with evidence-based guidelines.
{"title":"Comparative Analysis of Holmium Laser Enucleation of the Prostate (HoLEP) and Robotic Assisted Simple Prostatectomy (RASP) in BPH Management: A Systematic Review and Meta-Analysis.","authors":"Tarek Benzouak,Abdulmalik Addar,Michael A Prudencio-Brunello,Ammar Saed Aldien,Steve E Amougou,Ahmad AlShammari,Mohammed Ramadhan,Serge Carrier,Mélanie Aubé-Peterkin,Fadl Hamouche","doi":"10.1097/ju.0000000000004297","DOIUrl":"https://doi.org/10.1097/ju.0000000000004297","url":null,"abstract":"PURPOSEAs the prevalence of Benign Prostatic Hyperplasia (BPH) increases, the demand for surgical interventions that optimize patient outcomes while minimizing complications grows. This systematic review compares the efficacy, efficiency, and safety of Holmium Laser Enucleation of the Prostate (HoLEP) with Robotic-Assisted Simple Prostatectomy (RASP), providing insights for evidence-based surgical decision-making in BPH treatment.MATERIALS AND METHODSAdhering to PRISMA guidelines, the study protocol was registered with Prospero [CRD42024509627]. Searches were conducted in Medline, Embase, Web of Science, Scopus, and CINAHL up to February 1, 2024, to include studies that compare HoLEP and RASP in BPH patients. Risk of Bias was evaluated using the Newcastle Ottawa Scale.RESULTSHoLEP and RASP demonstrated equivalent effectiveness in treating BPH, as shown by similar functional outcomes like maximum urinary flow rate and post-void residual volume. However, HoLEP outperformed RASP in several operational efficiency metrics, reducing operative time by 49.48 minutes, hospitalization duration by 1.5 days, and catheterization period by 3.8 days. HoLEP also significantly reduced the risk of blood transfusions by 75%. Patients undergoing RASP were 1.87 times more at risk for grade 2 complications and 3.41 times more at risk for developing grade 3 or above complications.CONCLUSIONSHoLEP and RASP are effective for managing BPH. HoLEP shows advantages in recovery metrics and lower blood transfusion rates, while RASP benefits from ease of implementation in robotic-equipped facilities. Optimizing surgical outcomes will depend on reducing disparities in technique adoption, improving surgical training, and aligning with evidence-based guidelines.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"103 1","pages":"101097JU0000000000004297"},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451450","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 : 2024-10-18DOI: 10.1097/ju.0000000000004298
Eric V Li,Richard Bennett,Austin Ho,Clarissa Wong,Ashorne K Mahenthiran,Sai Kaushik Shankar Ramesh Kumar,Zequn Sun,Hatice Savas,Steven P Rowe,Edward M Schaeffer,Hiten D Patel,Ashley Ross
PURPOSEThere is limited data on PSMA PET/CT for work-up of recurrence after radical prostatectomy (RP) at low PSA values. We evaluated a PSMA PET/CT cohort of post-RP patients, focusing on patients with PSA <0.5 ng/mL.MATERIALS AND METHODSWe identified a retrospective cohort who underwent piflufolastat F-18 PSMA PET/CT across an eleven-hospital system from 7/2021-2/2023. PSMA positivity was determined by radiology reports. Univariable and multivariable logistic regression identified factors associated with suspicious PSMA activity.RESULTSMedian PSA was 0.37 ng/mL (IQR 0.15, 1.29 ng/mL), with 49% of patients overall having at least one suspicious PSMA-avid lesion. Rates of scan positivity among patients with PSA <0.2 and 0.2-0.5 ng/mL were 34% and 38%, respectively. Among all patients, 25% (104/415) had pelvic disease (prostate bed or N1), and 24% (100/415) had M1 disease. Among patients with PSA <0.5 ng/mL, prior post-operative radiation was associated with suspicious PSMA activity. In the overall cohort, age, PSA at PSMA PET/CT, and RP Gleason Grade (GG) were associated with PSMA positivity. PSADT, EAU risk, and CAPRA-S were all associated with suspicious PSMA activity.CONCLUSIONSOver one-third of patients with PSAs <0.2 ng/mL had imaging findings concerning for recurrence. Prior post-operative radiation was associated with higher rates of PSMA positivity among patients with PSA <0.5 ng/mL, and half of patients with evidence of PSMA avid distant metastatic disease underwent metastasis directed therapy. PET-PSMA imaging at low PSAs can be considered to inform salvage therapies.
{"title":"Clinical Factors Associated with Suspicious 18F-DCFPyL PSMA PET Activity in Patients Initially Managed with Radical Prostatectomy including PSA <0.5 ng/mL.","authors":"Eric V Li,Richard Bennett,Austin Ho,Clarissa Wong,Ashorne K Mahenthiran,Sai Kaushik Shankar Ramesh Kumar,Zequn Sun,Hatice Savas,Steven P Rowe,Edward M Schaeffer,Hiten D Patel,Ashley Ross","doi":"10.1097/ju.0000000000004298","DOIUrl":"https://doi.org/10.1097/ju.0000000000004298","url":null,"abstract":"PURPOSEThere is limited data on PSMA PET/CT for work-up of recurrence after radical prostatectomy (RP) at low PSA values. We evaluated a PSMA PET/CT cohort of post-RP patients, focusing on patients with PSA <0.5 ng/mL.MATERIALS AND METHODSWe identified a retrospective cohort who underwent piflufolastat F-18 PSMA PET/CT across an eleven-hospital system from 7/2021-2/2023. PSMA positivity was determined by radiology reports. Univariable and multivariable logistic regression identified factors associated with suspicious PSMA activity.RESULTSMedian PSA was 0.37 ng/mL (IQR 0.15, 1.29 ng/mL), with 49% of patients overall having at least one suspicious PSMA-avid lesion. Rates of scan positivity among patients with PSA <0.2 and 0.2-0.5 ng/mL were 34% and 38%, respectively. Among all patients, 25% (104/415) had pelvic disease (prostate bed or N1), and 24% (100/415) had M1 disease. Among patients with PSA <0.5 ng/mL, prior post-operative radiation was associated with suspicious PSMA activity. In the overall cohort, age, PSA at PSMA PET/CT, and RP Gleason Grade (GG) were associated with PSMA positivity. PSADT, EAU risk, and CAPRA-S were all associated with suspicious PSMA activity.CONCLUSIONSOver one-third of patients with PSAs <0.2 ng/mL had imaging findings concerning for recurrence. Prior post-operative radiation was associated with higher rates of PSMA positivity among patients with PSA <0.5 ng/mL, and half of patients with evidence of PSMA avid distant metastatic disease underwent metastasis directed therapy. PET-PSMA imaging at low PSAs can be considered to inform salvage therapies.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"20 1","pages":"101097JU0000000000004298"},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451451","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 : 2024-10-18DOI: 10.1097/ju.0000000000004299
Geoffrey Sonn
{"title":"Reviewer of the Month: Geoffrey Sonn.","authors":"Geoffrey Sonn","doi":"10.1097/ju.0000000000004299","DOIUrl":"https://doi.org/10.1097/ju.0000000000004299","url":null,"abstract":"","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"33 1","pages":"101097JU0000000000004299"},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142451449","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 : 2024-10-16DOI: 10.1097/ju.0000000000004279
Christian Daniel Fankhauser,Silvan Sigg,Nirmish Singla
{"title":"Letter: The Extraperitoneal Midline Approach: A Game Changer to Access the Retroperitoneum?","authors":"Christian Daniel Fankhauser,Silvan Sigg,Nirmish Singla","doi":"10.1097/ju.0000000000004279","DOIUrl":"https://doi.org/10.1097/ju.0000000000004279","url":null,"abstract":"","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"18 1","pages":"101097JU0000000000004279"},"PeriodicalIF":0.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142443764","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 : 2024-10-16DOI: 10.1097/ju.0000000000004270
Jonathan Alcantar,Brandon Piyevsky,Mohammed Shahait,Ryan W Dobbs
{"title":"Letter: Enhancing Patient-Centered Communication in Endourologic Research: A Call for Adoption of ASCO's Language of Respect Guidelines.","authors":"Jonathan Alcantar,Brandon Piyevsky,Mohammed Shahait,Ryan W Dobbs","doi":"10.1097/ju.0000000000004270","DOIUrl":"https://doi.org/10.1097/ju.0000000000004270","url":null,"abstract":"","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"68 1","pages":"101097JU0000000000004270"},"PeriodicalIF":0.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142443765","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 : 2024-10-16DOI: 10.1097/ju.0000000000004281
Karen E Johnson,David F Friedlander,Matthew E Nielsen
{"title":"From Error to Excellence: An Evolving Paradigm for Improving the Diagnostic Process.","authors":"Karen E Johnson,David F Friedlander,Matthew E Nielsen","doi":"10.1097/ju.0000000000004281","DOIUrl":"https://doi.org/10.1097/ju.0000000000004281","url":null,"abstract":"","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"99 1","pages":"101097JU0000000000004281"},"PeriodicalIF":0.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142448026","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 : 2024-10-16DOI: 10.1097/ju.0000000000004277
Miko Filon,Brock O'Neil
{"title":"Can We Be Less Active in Prostate Cancer Surveillance?","authors":"Miko Filon,Brock O'Neil","doi":"10.1097/ju.0000000000004277","DOIUrl":"https://doi.org/10.1097/ju.0000000000004277","url":null,"abstract":"","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"89 1","pages":"101097JU0000000000004277"},"PeriodicalIF":0.0,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142443763","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 : 2024-10-14DOI: 10.1097/ju.0000000000004285
Louis Lenfant,Yoann Taillé,Emmanuel Chartier-Kastler,Bertrand Lukacs,Thomas Seisen,Morgan Roupret,Aurélien Beaugerie,Eric Vicaut,Pierre C Mozer
PURPOSESignificant concerns remain regarding the long-term outcomes of AMS 800™ artificial urinary sphincter (AUS) implants in men. The objective was to assess the long-term AUS reintervention (replacement or removal) rates after a first-ever AUS implantation.MATERIALS AND METHODSThis population-based retrospective cohort study included all men aged ≥18 years in France who underwent a first-ever AUS implantation (identified using a unique device identifier) for male stress urinary incontinence (SUI) following prostate cancer (PCa) or benign prostatic hyperplasia (BPH) treatment, between January 1, 2006, and December 31, 2018. The primary outcome was reintervention-free survival rates (replacements and removals), estimated using the Kaplan-Meier method. Secondary outcomes were replacement and removal. A multivariable Cox proportional-hazards model was used to assess associations between patient and hospital factors and the hazard of reintervention.RESULTSThe study included 8,475 men with a median age of 69 years (IQR 65-74) and a median follow-up time of 6 years (IQR 3-9). Reintervention-free survival was 71% (95%CI, 70-72) at 2 years, 57% (95%CI, 55-58) at 5 years, and 40% (95%CI, 38-41) at 10 years. Reintervention-free survival was lower after BPH surgery, after radiotherapy combined with RP, and in centers performing fewer implantations. Removal-free survival was 83% (95% CI, 83%-84%) at 2 years, 75% (95% CI, 74%-76%) at 5 years, and 66% (95% CI, 65%-68%) at 10 years.CONCLUSIONSAmong men undergoing AUS implantation for SUI due to PCa or BPH treatment, the probability of reintervention was 29% within two years after implantation. The median time to reintervention was 6.6 years (IQR: 6.4-7.1), and the reintervention-free survival rate at 10 years was 40%. These insights can inform therapeutic decision-making for patients and surgeons during the management of male SUI.
{"title":"Artificial Urinary Sphincter Implants in Men: a National Healthcare Data System-based Study to Assess Reinterventions in France.","authors":"Louis Lenfant,Yoann Taillé,Emmanuel Chartier-Kastler,Bertrand Lukacs,Thomas Seisen,Morgan Roupret,Aurélien Beaugerie,Eric Vicaut,Pierre C Mozer","doi":"10.1097/ju.0000000000004285","DOIUrl":"https://doi.org/10.1097/ju.0000000000004285","url":null,"abstract":"PURPOSESignificant concerns remain regarding the long-term outcomes of AMS 800™ artificial urinary sphincter (AUS) implants in men. The objective was to assess the long-term AUS reintervention (replacement or removal) rates after a first-ever AUS implantation.MATERIALS AND METHODSThis population-based retrospective cohort study included all men aged ≥18 years in France who underwent a first-ever AUS implantation (identified using a unique device identifier) for male stress urinary incontinence (SUI) following prostate cancer (PCa) or benign prostatic hyperplasia (BPH) treatment, between January 1, 2006, and December 31, 2018. The primary outcome was reintervention-free survival rates (replacements and removals), estimated using the Kaplan-Meier method. Secondary outcomes were replacement and removal. A multivariable Cox proportional-hazards model was used to assess associations between patient and hospital factors and the hazard of reintervention.RESULTSThe study included 8,475 men with a median age of 69 years (IQR 65-74) and a median follow-up time of 6 years (IQR 3-9). Reintervention-free survival was 71% (95%CI, 70-72) at 2 years, 57% (95%CI, 55-58) at 5 years, and 40% (95%CI, 38-41) at 10 years. Reintervention-free survival was lower after BPH surgery, after radiotherapy combined with RP, and in centers performing fewer implantations. Removal-free survival was 83% (95% CI, 83%-84%) at 2 years, 75% (95% CI, 74%-76%) at 5 years, and 66% (95% CI, 65%-68%) at 10 years.CONCLUSIONSAmong men undergoing AUS implantation for SUI due to PCa or BPH treatment, the probability of reintervention was 29% within two years after implantation. The median time to reintervention was 6.6 years (IQR: 6.4-7.1), and the reintervention-free survival rate at 10 years was 40%. These insights can inform therapeutic decision-making for patients and surgeons during the management of male SUI.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"10 1","pages":"101097JU0000000000004285"},"PeriodicalIF":0.0,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142439367","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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