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1. Aquablation therapy in large prostates (80-150 cc) for lower urinary tract symptoms due to benign prostatic hyperplasia: WATER II 3-year trial results.

Author

Zorn, Kevin, Bidair, Mohamed, Trainer, Andrew, Arther, Andrew, Kramolowsky, Eugene, Desai, Mihir, Doumanian, Leo, Elterman, Dean, Kaufman, Ronald, Lingeman, James, Krambeck, Amy, Eure, Gregg, Badlani, Gopal, Plante, Mark, Gin, Greg, Goldenberg, S, Paterson, Ryan, So, Alan, Humphreys, Mitchell, Roehrborn, Claus, Kaplan, Steven, Motola, Jay, Bhojani, Naeem, and Uchio, Edward

Subjects
Aquablation, BPH, LUTS, prostate surgery, robotics, urology
Abstract

OBJECTIVE: The objective of this study is to determine if Aquablation therapy can maintain its effectiveness in treating men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with large-volume (80-150 cc) prostates at 3 years. SUBJECTS AND METHODS: One hundred one men with moderate-to-severe BPH symptoms and prostate volumes between 80 and 150 cc were enrolled in a prospective, nonrandomized, multicenter, international clinical trial in late 2017. Baseline, procedural, and follow-up parameters were recorded at baseline and scheduled postoperative visits. IPSS, Qmax, and treatment failure are reported at 3 years. RESULTS: The mean prostate volume was 107 cc (range 80-150). Mean IPSS improved from 23.2 at baseline to 6.5 at 3 years (16.3-point improvement, p

Published
2022

2. MP41-02 COMBINING SERUM PROSTATE HEALTH INDEX WITH URINARY PCA3 AND TMPRSS2:ERG RNA TESTING IMPROVES DETECTION OF CLINICALLY-SIGNIFICANT PROSTATE CANCER

Author

Narayan, Vikram M., primary, Eyrich, Nicholas, additional, Huang, Eugene, additional, Zheng, Yingye, additional, Wei, John, additional, Sokoll, Lori, additional, Chan, Daniel, additional, Patil, Dattatraya, additional, Chinnaiyan, Arul, additional, Tomlins, Scott A., additional, Lotan, Yair, additional, Lin, Daniel, additional, Scherr, Douglas, additional, Kibel, Adam, additional, Taneja, Samir S., additional, Bidair, Mohamed, additional, Thompson, Ian M., additional, and Sanda, Martin G., additional

Published
2024
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5. The Safety and Antiviral Activity of BZF961 with or without Ritonavir in Patients Infected with Hepatitis C Virus: A Randomized, Multicenter Trial

Author

Lawitz, Eric, Bidair, Mohamed, Marbury, Thomas, Jones, Christopher T., Barve, Avantika, Magnusson, Baldur, Barkan, David T., Bodendorf, Ursula, Bracken, Kathryn, Canino, Erica, Chen, Darlene, Dabovic, Kristina, Heimbach, Tycho, Ison, Marjorie, Jones, Catherine L., Kovacs, Steven J., Lakshman, Jay P., Li, Bin, Raman, Prakash, Steiner-Swiat, Rachael, Thohan, Sanjeev, Wong, Kelly A., Zhong, Weidong, and Colvin, Richard A.

Published
2018
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6. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia

Author

Gilling, Peter, Barber, Neil, Bidair, Mohamed, Anderson, Paul, Sutton, Mark, Aho, Tev, Kramolowsky, Eugene, Thomas, Andrew, Cowan, Barrett, Kaufman, Ronald P., Jr., Trainer, Andrew, Arther, Andrew, Badlani, Gopal, Plante, Mark, Desai, Mihir, Doumanian, Leo, Te, Alexis E., DeGuenther, Mark, and Roehrborn, Claus

Published
2018
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10. Effect of Meropenem-Vaborbactam vs Piperacillin-Tazobactam on Clinical Cure or Improvement and Microbial Eradication in Complicated Urinary Tract Infection: The TANGO I Randomized Clinical Trial

Author

Kaye, Keith S., Bhowmick, Tanaya, Metallidis, Symeon, Bleasdale, Susan C., Sagan, Olexiy S., Stus, Viktor, Vazquez, Jose, Zaitsev, Valerii, Bidair, Mohamed, Chorvat, Erik, Dragoescu, Petru Octavian, Fedosiuk, Elena, Horcajada, Juan P., Murta, Claudia, Sarychev, Yaroslav, Stoev, Ventsislav, Morgan, Elizabeth, Fusaro, Karen, Griffith, David, Lomovskaya, Olga, Alexander, Elizabeth L., Loutit, Jeffery, Dudley, Michael N., and Giamarellos-Bourboulis, Evangelos J.

Published
2018
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11. Aquablation therapy in large prostates (80–150 cc) for lower urinary tract symptoms due to benign prostatic hyperplasia: WATER II 3‐year trial results

Author

Zorn, Kevin C., primary, Bidair, Mohamed, additional, Trainer, Andrew, additional, Arther, Andrew, additional, Kramolowsky, Eugene, additional, Desai, Mihir, additional, Doumanian, Leo, additional, Elterman, Dean, additional, Kaufman, Ronald P., additional, Lingeman, James, additional, Krambeck, Amy, additional, Eure, Gregg, additional, Badlani, Gopal, additional, Plante, Mark, additional, Uchio, Edward, additional, Gin, Greg, additional, Goldenberg, S. Larry, additional, Paterson, Ryan, additional, So, Alan, additional, Humphreys, Mitchell, additional, Roehrborn, Claus, additional, Kaplan, Steven, additional, Motola, Jay, additional, and Bhojani, Naeem, additional

Published
2021
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12. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial

Author

Lopes, Renato D., primary, Higano, Celestia S., additional, Slovin, Susan F., additional, Nelson, Adam J., additional, Bigelow, Robert, additional, Sørensen, Per S., additional, Melloni, Chiara, additional, Goodman, Shaun G., additional, Evans, Christopher P., additional, Nilsson, Jan, additional, Bhatt, Deepak L., additional, Clarke, Noel W., additional, Olesen, Tine K., additional, Doyle-Olsen, Belinda T., additional, Kristensen, Henriette, additional, Arney, Lauren, additional, Roe, Matthew T., additional, Alexander, John H., additional, Mol-Arts, Mirjam, additional, Mansor-Lefebvre, Samreen, additional, Zubovskiy, Konstantin, additional, Blemings, Allan, additional, Dugi, Klaus, additional, Bloomfield, Gerald, additional, Kontos, Chris, additional, DeVore, Adam, additional, Jordan, Dedrick, additional, Kolls, Bradley, additional, Matthews, Robin, additional, Mehta, Rajendra, additional, Povsic, Thomas J., additional, Morse, Michael, additional, Mahaffey, Kenneth W., additional, Halabi, Susan, additional, Leong, Darryl, additional, Klotz, Laurence, additional, Fleshner, Neil, additional, Jansz, Godfrey, additional, Giddens, Jonathan, additional, Egerdie, Russell, additional, Chin, Joseph, additional, Zadra, Joseph, additional, Casey, Richard, additional, Simard, Jean, additional, Niazi, Tamim, additional, Martin, André-Guy, additional, Babjuk, Marek, additional, Hajek, Jaroslav, additional, Klecka, Jiri, additional, Kubes, Jiri, additional, Schraml, Jan, additional, Jakesova, Jitka, additional, Vanasek, Jaroslav, additional, Melichar, Bohuslav, additional, Seikkula, Heikki, additional, Abdiche, Manouar Samir, additional, Colombel, Marc, additional, Debourdeau, Philippe, additional, Robert, Gregoire, additional, Villers, Arnauld, additional, Ploussard, Guillaume, additional, Pradere, Benjamin, additional, Bruyere, Franck, additional, Descotes, Jean-Luc, additional, Ouzaid, Idir, additional, Winter, Alexander, additional, Hanitzsch, Herbert, additional, Sperling, Herbert, additional, Eckert, Ralf, additional, Hammerer, Peter, additional, Stagge, Elke, additional, Seseke, Florian, additional, Szymula, Silvio, additional, Bamias, Aristotelis, additional, Thanos, Anastasios, additional, Hatzimouratidis, Konstantinos, additional, Mamoulakis, Charalambos, additional, Kalofonos, Haralabos, additional, Oszukowska, Elzbieta, additional, Madziarska, Katarzyna, additional, Fijuth, Jacek, additional, Obarzanowski, Mateusz, additional, Alekseev, Boris, additional, Atduev, Vagif, additional, Pushkar, Dmitri, additional, Veliev, Evgeniy, additional, Zyryanov, Alexander, additional, Petrov, Sergey, additional, Kopyltsov, Evgeny, additional, Kozlov, Vadim, additional, Macko, Ladislav, additional, Dubravicky, Jozef, additional, Polak, Richard, additional, Mir, Obaidullah, additional, Vargovcak, Marek, additional, Mincik, Ivan, additional, Kliment, Jan, additional, Goncalves, Frederico, additional, Mikulas, Juraj, additional, Sokol, Roman, additional, Korcek, Michal, additional, Marko, Jozef, additional, Kovacik, Viktor, additional, Milichovsky, Igor, additional, Dubinsky, Pavol, additional, Lazarus, John, additional, Dixit, Sanjay, additional, Green, Euan, additional, Srinivasan, Rajaguru, additional, Mazhar, Danish, additional, Ng, Yeung, additional, Sarwar, Naveed, additional, Herman, Craig, additional, Snoy, Frederick, additional, Given, Robert, additional, Suh, Ronald, additional, Lipsitz, David, additional, Bailen, James, additional, Gervasi, Lawrence, additional, Acosta, Idalia, additional, Belkoff, Laurence, additional, Wu, Ning, additional, Frankel, Jeffrey, additional, Karsh, Lawrence, additional, Poole, Bryant, additional, Lieber, David, additional, Engel, Jason, additional, Bidair, Mohamed, additional, Rosenberg, Steven, additional, Sieber, Paul, additional, Perzin, Adam, additional, Kalota, Susan, additional, Singh, Amar, additional, Henderson, Ralph, additional, Wayne, Jeffrey, additional, Mirza, Moben, additional, D’Anna, Richard, additional, Wolk, Fredrick, additional, Padron, Osvaldo, additional, Bylow, Kathryn, additional, Rubenstein, Jonathan, additional, Gartrell, Benjamin, additional, Schwartz, Michael, additional, Patel, Kalpesh, additional, Maniam, Ajit, additional, Keane, Thomas, additional, Goodman, Michael, additional, Bane, Charles, additional, Chung, Michael, additional, Savage, Stephen, additional, Uchio, Edward, additional, Nguyen, Son, additional, Aronson, William, additional, Khanna, Rakesh, additional, and Barnswell, Carlton, additional

Published
2021
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14. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results

Author

Bhojani, Naeem, Bidair, Mohamed, Zorn, Kevin C., Trainer, Andrew, Arther, Andrew, Kramolowsky, Eugene, Doumanian, Leo, Elterman, Dean, Kaufman, Ronald P., Lingeman, James, Krambeck, Amy, Eure, Gregg, Badlani, Gopal, Plante, Mark, Uchio, Edward, Gin, Greg, Goldenberg, Larry, Paterson, Ryan, So, Alan, Humphreys, Mitch, Kaplan, Steven, Motola, Jay, Desai, Mihir, and Roehrborn, Claus

Published
2019
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16. Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial

Author

Plante, Mark, primary, Gilling, Peter, additional, Barber, Neil, additional, Bidair, Mohamed, additional, Anderson, Paul, additional, Sutton, Mark, additional, Aho, Tev, additional, Kramolowsky, Eugene, additional, Thomas, Andrew, additional, Cowan, Barrett, additional, Kaufman, Ronald P., additional, Trainer, Andrew, additional, Arther, Andrew, additional, Badlani, Gopal, additional, Desai, Mihir, additional, Doumanian, Leo, additional, Te, Alexis E., additional, DeGuenther, Mark, additional, and Roehrborn, Claus, additional

Published
2018
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17. WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation ® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia

Author

Gilling, Peter, primary, Barber, Neil, additional, Bidair, Mohamed, additional, Anderson, Paul, additional, Sutton, Mark, additional, Aho, Tev, additional, Kramolowsky, Eugene, additional, Thomas, Andrew, additional, Cowan, Barrett, additional, Kaufman, Ronald P., additional, Trainer, Andrew, additional, Arther, Andrew, additional, Badlani, Gopal, additional, Plante, Mark, additional, Desai, Mihir, additional, Doumanian, Leo, additional, Te, Alexis E., additional, DeGuenther, Mark, additional, and Roehrborn, Claus, additional

Published
2018
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18. Re: Association Between Combined TMPRSS2:ERG and PCA3 RNA Urinary Testing and Detection of Aggressive Prostate Cancer

Author

Sanda, Martin G, Feng, Ziding, Howard, David H, Tomlins, Scott A, Sokoll, Lori J, Chan, Daniel W, Regan, Meredith M, Groskopf, Jack, Chipman, Jonathan, Patil, Dattatraya H, Salami, Simpa S, Scherr, Douglas S, Kagan, Jacob, Srivastava, Sudhir, Thompson, Ian M, Siddiqui, Javed, Fan, Jing, Joon, Aron Y, Bantis, Leonidas E, Rubin, Mark Andrew, Chinnayian, Arul M, Wei, John T, Bidair, Mohamed, Kibel, Adam, Lin, Daniel W, Lotan, Yair, Partin, Alan, and Taneja, Samir

Subjects
Adult, Male, PCA3, Oncology, Cancer Research, medicine.medical_specialty, Prostate biopsy, genetic structures, Oncogene Proteins, Fusion, Urology, Urinary system, 030232 urology & nephrology, Urinalysis, urologic and male genital diseases, TMPRSS2, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, Transcriptional Regulator ERG, Prostate, Antigens, Neoplasm, Internal medicine, Biomarkers, Tumor, medicine, Humans, Neoplasm, Overdiagnosis, Prospective cohort study, Original Investigation, Aged, Aged, 80 and over, medicine.diagnostic_test, business.industry, Prostatic Neoplasms, RNA, Middle Aged, 500 Science, medicine.disease, Prostate-specific antigen, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Costs and Cost Analysis, 570 Life sciences, biology, Neoplasm Grading, business, Erg
Abstract

Importance Potential survival benefits from treating aggressive (Gleason score, ≥7) early-stage prostate cancer are undermined by harms from unnecessary prostate biopsy and overdiagnosis of indolent disease. Objective To evaluate the a priori primary hypothesis that combined measurement of PCA3 and TMPRSS2:ERG ( T2:ERG ) RNA in the urine after digital rectal examination would improve specificity over measurement of prostate-specific antigen alone for detecting cancer with Gleason score of 7 or higher. As a secondary objective, to evaluate the potential effect of such urine RNA testing on health care costs. Design, Setting, and Participants Prospective, multicenter diagnostic evaluation and validation in academic and community-based ambulatory urology clinics. Participants were a referred sample of men presenting for first-time prostate biopsy without preexisting prostate cancer: 516 eligible participants from among 748 prospective cohort participants in the developmental cohort and 561 eligible participants from 928 in the validation cohort. Interventions/Exposures Urinary PCA3 and T2:ERG RNA measurement before prostate biopsy. Main Outcomes and Measures Presence of prostate cancer having Gleason score of 7 or higher on prostate biopsy. Pathology testing was blinded to urine assay results. In the developmental cohort, a multiplex decision algorithm was constructed using urine RNA assays to optimize specificity while maintaining 95% sensitivity for predicting aggressive prostate cancer at initial biopsy. Findings were validated in a separate multicenter cohort via prespecified analysis, blinded per prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) criteria. Cost effects of the urinary testing strategy were evaluated by modeling observed biopsy results and previously reported treatment outcomes. Results Among the 516 men in the developmental cohort (mean age, 62 years; range, 33-85 years) combining testing of urinary T2:ERG and PCA3 at thresholds that preserved 95% sensitivity for detecting aggressive prostate cancer improved specificity from 18% to 39%. Among the 561 men in the validation cohort (mean age, 62 years; range, 27-86 years), analysis confirmed improvement in specificity (from 17% to 33%; lower bound of 1-sided 95% CI, 0.73%; prespecified 1-sided P = .04), while high sensitivity (93%) was preserved for aggressive prostate cancer detection. Forty-two percent of unnecessary prostate biopsies would have been averted by using the urine assay results to select men for biopsy. Cost analysis suggested that this urinary testing algorithm to restrict prostate biopsy has greater potential cost-benefit in younger men. Conclusions and Relevance Combined urinary testing for T2:ERG and PCA3 can avert unnecessary biopsy while retaining robust sensitivity for detecting aggressive prostate cancer with consequent potential health care cost savings.

Published
2018
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19. Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial.

Author

Plante, Mark, Cowan, Barrett, Kaufman, Ronald P., Trainer, Andrew, Arther, Andrew, Badlani, Gopal, Desai, Mihir, Doumanian, Leo, Te, Alexis E., DeGuenther, Mark, Roehrborn, Claus, Gilling, Peter, Barber, Neil, Bidair, Mohamed, Anderson, Paul, Sutton, Mark, Aho, Tev, Kramolowsky, Eugene, and Thomas, Andrew

Subjects
TRANSURETHRAL prostatectomy, PROSTATE
Abstract

Objective: To test the hypothesis that benign prostatic hyperplasia (BPH) robotic surgery with aquablation would have a more pronounced benefit in certain patient subgroups, such as men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH. Methods: We conducted prespecified and post hoc exploratory subgroup analyses from a double‐blind, multicentre prospective randomized controlled trial that compared transurethral resection of the prostate (TURP) using either standard electrocautery vs surgery using robotic waterjet (aquablation) to determine whether certain baseline factors predicted more marked responses after aquablation as compared with TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien–Dindo persistent grade 1 or grade ≥2 surgical complications. Results: For men with larger prostates (50–80 g), the mean IPSS reduction was four points greater after aquablation than after TURP (P = 0.001), a larger difference than the overall result (1.8 points; P = 0.135). Similarly, the primary safety endpoint difference (20% vs 46% [26% difference]; P = 0.008) was greater for men with large prostate compared with the overall result (26% vs 42% [16% difference]; P = 0.015). Postoperative anejaculation was also less common after aquablation compared with TURP in sexually active men with large prostates (2% vs 41%; P < 0.001) vs the overall results (10% vs 36%; P < 0.001). Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post‐void residual urine volume. Conclusions: In men with moderate‐to‐severe lower urinary tract symptoms attributable to BPH and larger, more complex prostates, aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation. The standardized, robotically executed, surgical approach with aquablation may overcome the increased outcome variability in more complex anatomy, resulting in superior symptom score reduction. [ABSTRACT FROM AUTHOR]

Published
2019
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20. Can Urinary PCA3 Supplement PSA in the Early Detection of Prostate Cancer?

Author

Wei, John T., primary, Feng, Ziding, additional, Partin, Alan W., additional, Brown, Elissa, additional, Thompson, Ian, additional, Sokoll, Lori, additional, Chan, Daniel W., additional, Lotan, Yair, additional, Kibel, Adam S., additional, Busby, J. Erik, additional, Bidair, Mohamed, additional, Lin, Daniel W., additional, Taneja, Samir S., additional, Viterbo, Rosalia, additional, Joon, Aron Y., additional, Dahlgren, Jackie, additional, Kagan, Jacob, additional, Srivastava, Sudhir, additional, and Sanda, Martin G., additional

Published
2014
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22. 2206 THE NCI EARLY DETECTION RESEARCH NETWORK (EDRN) URINARY PCA3 VALIDATION TRIAL

Author

Wei, John, primary, Sanda, Martin, additional, Thompson, Ian, additional, Partin, Alan, additional, Feng, Zideng, additional, Sokoll, Lori, additional, Groskopf, Jack, additional, Brown, Elissa, additional, Lotan, Yair, additional, Kibel, Adam, additional, Busby, Erik, additional, Bidair, Mohamed, additional, Lin, Dan, additional, Taneja, Samir, additional, and Viterbo, Rosalia, additional

Published
2012
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23. Abstract 4451: The NCI Early Detection Research Network (EDRN) urinary PCA3 validation trial

Author

Wei, John Thomas, primary, Sanda, Martin G., additional, Thompson, Ian M., additional, Partin, Alan, additional, Feng, Ziding, additional, Sokoll, Lori, additional, Groskopf, Jack, additional, Brown, Elissa, additional, Lotan, Yair, additional, Kibel, Adam, additional, Lin, Daniel, additional, Taneja, Samir, additional, Viterbo, Rosalia, additional, Busby, Erik, additional, Bidair, Mohamed, additional, Kagan, Jacob, additional, and Srivastava, Sudhir, additional

Published
2012
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24. Association Between Combined TMPRSS2:ERG and PCA3 RNA Urinary Testing and Detection of Aggressive Prostate Cancer

Author

Sanda, Martin G., Feng, Ziding, Howard, David H., Tomlins, Scott A., Sokoll, Lori J., Chan, Daniel W., Regan, Meredith M., Groskopf, Jack, Chipman, Jonathan, Patil, Dattatraya H., Salami, Simpa S., Scherr, Douglas S., Kagan, Jacob, Srivastava, Sudhir, Thompson, Ian M., Siddiqui, Javed, Fan, Jing, Joon, Aron Y., Bantis, Leonidas E., Rubin, Mark A., Chinnayian, Arul M., Wei, John T., Bidair, Mohamed, Kibel, Adam, Lin, Daniel W., Lotan, Yair, Partin, Alan, and Taneja, Samir

Abstract

IMPORTANCE: Potential survival benefits from treating aggressive (Gleason score, ≥7) early-stage prostate cancer are undermined by harms from unnecessary prostate biopsy and overdiagnosis of indolent disease. OBJECTIVE: To evaluate the a priori primary hypothesis that combined measurement of PCA3 and TMPRSS2:ERG (T2:ERG) RNA in the urine after digital rectal examination would improve specificity over measurement of prostate-specific antigen alone for detecting cancer with Gleason score of 7 or higher. As a secondary objective, to evaluate the potential effect of such urine RNA testing on health care costs. DESIGN, SETTING, AND PARTICIPANTS: Prospective, multicenter diagnostic evaluation and validation in academic and community-based ambulatory urology clinics. Participants were a referred sample of men presenting for first-time prostate biopsy without preexisting prostate cancer: 516 eligible participants from among 748 prospective cohort participants in the developmental cohort and 561 eligible participants from 928 in the validation cohort. INTERVENTIONS/EXPOSURES: Urinary PCA3 and T2:ERG RNA measurement before prostate biopsy. MAIN OUTCOMES AND MEASURES: Presence of prostate cancer having Gleason score of 7 or higher on prostate biopsy. Pathology testing was blinded to urine assay results. In the developmental cohort, a multiplex decision algorithm was constructed using urine RNA assays to optimize specificity while maintaining 95% sensitivity for predicting aggressive prostate cancer at initial biopsy. Findings were validated in a separate multicenter cohort via prespecified analysis, blinded per prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) criteria. Cost effects of the urinary testing strategy were evaluated by modeling observed biopsy results and previously reported treatment outcomes. RESULTS: Among the 516 men in the developmental cohort (mean age, 62 years; range, 33-85 years) combining testing of urinary T2:ERG and PCA3 at thresholds that preserved 95% sensitivity for detecting aggressive prostate cancer improved specificity from 18% to 39%. Among the 561 men in the validation cohort (mean age, 62 years; range, 27-86 years), analysis confirmed improvement in specificity (from 17% to 33%; lower bound of 1-sided 95% CI, 0.73%; prespecified 1-sided P = .04), while high sensitivity (93%) was preserved for aggressive prostate cancer detection. Forty-two percent of unnecessary prostate biopsies would have been averted by using the urine assay results to select men for biopsy. Cost analysis suggested that this urinary testing algorithm to restrict prostate biopsy has greater potential cost-benefit in younger men. CONCLUSIONS AND RELEVANCE: Combined urinary testing for T2:ERG and PCA3 can avert unnecessary biopsy while retaining robust sensitivity for detecting aggressive prostate cancer with consequent potential health care cost savings.

Published
2017
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29. Case Reports

Author

Tay, Howard P., primary, Bidair, Mohamed, additional, Shabaik, Ahmed, additional, Gilbaugh, James H., additional, and Schmidt, Joseph D., additional

Published
1995
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35. Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH.

Author

Gilling PJ, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Kaufman RP Jr, Badlani G, Plante M, Desai M, Doumanian L, Te AE, and Roehrborn CG

Subjects
Humans, Male, Prospective Studies, Treatment Outcome, Ablation Techniques adverse effects, Ablation Techniques methods, Lower Urinary Tract Symptoms etiology, Lower Urinary Tract Symptoms surgery, Prostatic Hyperplasia complications, Prostatic Hyperplasia surgery, Transurethral Resection of Prostate adverse effects, Transurethral Resection of Prostate methods
Abstract

Introduction: To determine if Aquablation therapy can maintain long term effectiveness in treating men with moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with a baseline prostate volume between 30 and 80 mL at 5 years compared to TURP., Materials and Methods: In a double-blinded, multicenter prospective randomized controlled trial, 181 patients with moderate to severe LUTS secondary to BPH underwent TURP or Aquablation. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent Grade 1 or Grade 2 or higher operative complications at 3 months. The assessments included IPSS, Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and uroflow (Qmax). The patients were followed for 5 years., Results: The primary safety endpoint was successfully achieved at 3 months where the Aquablation group had a lower event rate than TURP (26% vs. 42%, p = .0149 for superiority). Procedure-related ejaculatory dysfunction was lower for Aquablation (7% vs. 25%, p = .0004). The primary efficacy endpoint was successfully achieved at 6 months, where the mean IPSS decreased from baseline by 16.9 points for Aquablation and 15.1 points for TURP; the mean difference in change score at 6 months was 1.8 points larger for Aquablation (p < .0001 for non-inferiority, p = .1346 for superiority). At 5 years, IPSS scores improved by 15.1 points in the Aquablation group and 13.2 points in TURP (p = .2764). However, for men with larger prostates (≥ 50 mL), IPSS reduction was 3.5 points greater across all follow up visits in the Aquablation group compared to the TURP group (p = .0123). Improvement in peak urinary flow rate was 125% and 89% compared to baseline for Aquablation and TURP, respectively. The risk of patients needing a secondary BPH therapy, defined as needing BPH medication or surgical intervention, up to 5 years due to recurrent LUTS was 51% less in the Aquablation arm compared to the TURP arm., Conclusions: The improvement in net health outcomes from Aquablation therapy outweigh those offered by a TURP when considering the efficacy benefit along with the lower risk of needing a secondary BPH therapy and avoiding retrograde ejaculation. Following Aquablation therapy, symptom reduction and uroflow improvement at 5 years have shown to be durable and consistent across all years of follow up compared to TURP. Larger prostates (≥ 50 mL) demonstrated a larger safety and efficacy benefit for Aquablation over TURP.

Published
2022

36. Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial.

Author

Gilling P, Barber N, Bidair M, Anderson P, Sutton M, Aho T, Kramolowsky E, Thomas A, Cowan B, Kaufman RP Jr, Trainer A, Arther A, Badlani G, Plante M, Desai M, Doumanian L, Te AE, DeGuenther M, and Roehrborn C

Subjects
Aged, Double-Blind Method, Humans, Lower Urinary Tract Symptoms etiology, Male, Middle Aged, Prostatic Hyperplasia complications, Time Factors, Transurethral Resection of Prostate, Treatment Outcome, Water, Ablation Techniques methods, Lower Urinary Tract Symptoms surgery, Prostatectomy methods, Prostatic Hyperplasia surgery
Abstract

Introduction: To compare 3-year efficacy and safety after prostate resection with Aquablation therapy or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostate hyperplasia (BPH)., Materials and Methods: One hundred and eighty-one patients assigned to either Aquablation therapy or TURP were followed for 3 years postoperatively. Patients and follow up assessors were blinded to treatment. Assessments included International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire (MSHQ-EjD), International Index of Erectile Function (IIEF) and uroflow., Results: Over 3 years of treatment, improvements in IPSS scores were statistically similar across groups. Mean 3-year improvements were 14.4 and 13.9 points in the Aquablation and TURP groups, respectively (difference of 0.6 points, 95% CI -3.3-2.2, p = .6848). Similarly, 3-year improvements in Qmax were 11.6 and 8.2 cc/sec (difference of 3.3 [95% CI -0.5-7.1] cc/sec, p = .0848). At 3 years, PSA was reduced significantly in both groups by 0.9 and 1.1 ng/mL, respectively; the reduction was similar across groups (p = .5983). There were no surgical retreatments for BPH beyond 20 months for either Aquablation or TURP., Conclusions: Three-year BPH symptom reduction and urinary flow rate improvement were similar after TURP and Aquablation therapy. No subjects required surgical retreatment beyond 20 months postoperatively. (ClinicalTrials.gov number, NCT02505919).

Published
2020

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