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The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial

Chughtai, Bilal; Elterman, Dean; Shore, Neal; Gittleman, Marc; Motola, Jay; Pike, Sheldon; Hermann, Craig; Terrens, William; Kohan, Alfred; Gonzalez, Ricardo R; Katz, Aaron; Schiff, Jeffery; Goldfischer, Evan; Grunberger, Ivan; Tu, Le Mai; Alshak, Mark N; Kaminetzky, Jed
OBJECTIVE:To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS/METHODS:Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months. RESULTS:A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred. CONCLUSION/CONCLUSIONS:Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.
PMID: 33373708
ISSN: 1527-9995
CID: 4770992

Pathologic measures of quality compare favorably in patients undergoing robot-assisted radical cystectomy to open cystectomy cohorts: a National Cancer Database analysis

Miguel, Carla M; Kosinski, Kaitlin E; Fazzari, Melissa J; Kongnyuy, Michael; Smaldone, Marc C; Schiff, Jeffrey T; Katz, Aaron E; Corcoran, Anthony T
This study aims to assess the impact of facility characteristics on measures of surgical quality (positive surgical margin rates and lymph-node yield) in patients undergoing robot-assisted (RARC) versus open (ORC) radical cystectomy using the National Cancer Database. Patients who received RC between the years of 2010-2013 were stratified according to surgery type (ORC vs. RARC), and corresponding patient and facility-level variables (facility type and volume) were assessed. Logistic regression models for procedure type, positive surgical margins (PSMs), and LN dissection (LND) rates were estimated. Radical cystectomies (ORC = 13,236, RARC = 3687) were performed more often in academic centers (58.3%) compared to community centers (31.6%). As facility volume increased, centers performed more LNDs during ORCs (p = 0.03) and the number of nodes retrieved increased in both ORC and RARC (ORC p < 0.001; RARC p < 0.0001). Increased facility volume also resulted in significantly fewer PSMs within the RARC cohort (p = 0.01). Comparison of ORC and RARC within each facility type cohort identified improved pathological metrics for RARC with fewer PSMs (p = 0.001) as well as increased LNDs (p < 0.0001) and median number of LNs retrieved (p < 0.0001), which suggests that RARC may facilitate comparative outcomes in community centers and academic centers. Overall, higher facility volume and robot-assisted surgery resulted in more favorable pathologic metrics compared to lower facility volume and ORC.
PMID: 31583520
ISSN: 1863-2491
CID: 4116922

A Case of a Primary Intratesticular Leiomyosarcoma with Metastatic Disease

Berg, Courtney; Vedula, Jogarao; Sueur, Amanda Le; Drexler, Steven; Schiff, Jeffrey
PMID: 31470025
ISSN: 1527-9995
CID: 4054042

Patient-reported quality of life progression in men with prostate cancer following primary cryotherapy, cyberknife, or active holistic surveillance

Werneburg, Glenn T; Kongnyuy, Michael; Halpern, Daniel M; Salcedo, Jose M; Kosinski, Kaitlin E; Haas, Jonathan A; Schiff, Jeffrey T; Corcoran, Anthony T; Katz, Aaron E
BACKGROUND:Technological advancements have led to the success of minimally invasive treatment modalities for prostate cancer such as CyberKnife and Cryotherapy. Here, we investigate patient-reported urinary function, bowel habits, and sexual function in patients following CyberKnife (CK) or Cryotherapy treatment, and compare them with active holistic surveillance (AHS) patients. METHODS:An IRB-approved institutional database was retrospectively reviewed for patients who underwent CK, Cryotherapy, or AHS. Quality of life (QoL) survey responses were collected every three months and the mean function scores were analyzed in yearly intervals over the 4 years post-treatment. RESULTS:279 patients (767 survey sets) were included in the study. There was no difference among groups in urinary function scores. The CyberKnife group had significantly lower bowel habit scores in the early years following treatment (year 2 mean difference: -5.4, P < 0.01) but returned to AHS level scores by year 4. Cryotherapy patients exhibited initially lower, but not statistically significant, bowel function scores, which then improved and approached those of AHS. Both CyberKnife (year 1 mean difference: -26.7, P < 0.001) and Cryotherapy groups (-35.4, P < 0.001) had early lower sexual function scores relative to AHS, but then gradually improved and were not significantly different from AHS by the third year post-treatment. A history of hormonal therapy was associated with a lower sexual function scores relative to those patients who did not receive hormones in both CyberKnife (-18.45, P < 0.01) and Cryotherapy patients (-14.6, P < 0.05). CONCLUSIONS:After initial lower bowel habits and sexual function scores, CyberKnife or Cryotherapy-treated patients had no significant difference in QoL relative to AHS patients. These results highlight the benefit of CyberKnife and Cryotherapy in the management of organ-confined prostate cancer.
PMID: 29217830
ISSN: 1476-5608
CID: 3499132

MODERATE MINIMUM TUMOR TEMPERATURE IN CRYOTHERAPY IS ASSOCIATED WITH SUPERIOR QUALITY OF LIFE AND NO DIFFERENCE IN DISEASE CONTROL IN PROSTATE CANCER PATIENTS [Meeting Abstract]

Werneburg, Glenn T.; Kongnyuy, Michael; Halpern, Daniel M.; Salcedo, Jose M.; Chen, Connie; LeSueur, Amanda L.; Kosinski, Kaitlin E.; Schiff, Jeffrey T.; Corcoran, Anthony T.; Katz, Aaron E.
ISI:000429166601100
ISSN: 0022-5347
CID: 3494312

PRIMARY TREATMENT MODALITY FOR PROSTATE CANCER IS ASSOCIATED WITH RISK OF BIOCHEMICAL RECURRENCE FOLLOWING SALVAGE CRYOTHERAPY [Meeting Abstract]

Werneburg, Glenn T.; Salcedo, Jose M.; LeSueur, Amanda L.; Haas, Jonathan A.; Schiff, Jeffrey T.; Corcoran, Anthony T.; Katz, Aaron E.
ISI:000429166601705
ISSN: 0022-5347
CID: 3494352

COMBINATION OF PSA DENSITY, PROSTATE CANCER ANTIGEN 3 AND PI-RADS IN THE PREDICTION OF PROSTATE CANCER IN INITIAL BIOPSY [Meeting Abstract]

Fazzari, Melissa J.; Salcedo, Jose M.; Gildersleeve, Roy T.; Werneburg, Glenn T.; Le Sueur, Amanda L.; Schiff, Jeffrey T.; Corcoran, Anthony T.; Katz, Aaron E.
ISI:000429166601611
ISSN: 0022-5347
CID: 3494342

INITIAL SCREENING USING PCA3 WITH PSAD IMPROVED PROSTATE CANCER DETECTION [Meeting Abstract]

Fazzari, Melissa J.; Salcedo, Jose M.; Gildersleeve, Roy T.; Werneburg, Glenn T.; Le Sueur, Amanda L.; Schiff, Jeffrey T.; Corcoran, Anthony T.; Katz, Aaron E.
ISI:000429166601605
ISSN: 0022-5347
CID: 3494332

FOCAL CRYOABLATION IS ASSOCIATED WITH SUPERIOR QUALITY OF LIFE AND NO DIFFERENCE IN DISEASE CONTROL RELATIVE TO TOTAL CRYOABLATION IN PROSTATE CANCER PATIENTS [Meeting Abstract]

Werneburg, Glenn T.; Kongnyuy, Michael; Halpern, Daniel M.; Salcedo, Jose M.; Chen, Connie; LeSueur, Amanda L.; Kosinski, Kaitlin E.; Schiff, Jeffrey T.; Corcoran, Anthony T.; Katz, Aaron E.
ISI:000429166601103
ISSN: 0022-5347
CID: 3494322

Effects of Focal vs Total Cryotherapy and Minimum Tumor Temperature on Patient-reported Quality of Life Compared With Active Surveillance in Patients With Prostate Cancer

Werneburg, Glenn T; Kongnyuy, Michael; Halpern, Daniel M; Salcedo, Jose M; Chen, Connie; LeSueur, Amanda; Kosinski, Kaitlin E; Schiff, Jeffrey T; Corcoran, Anthony T; Katz, Aaron E
OBJECTIVE:To investigate the effects of focal (hemiablation) or total cryotherapy and minimum tumor temperature on patient-reported quality of life (QoL) in patients with prostate cancer. METHODS:An Institutional Review Board-approved database was reviewed for patients who underwent cryotherapy or active surveillance (AS). QoL questionnaire responses were collected and scores were analyzed for differences between focal and total cryotherapy and between very cold (<-76°C) and moderate-cold (≥-76°C) minimum tumor temperatures. RESULTS:A total of 197 patients responded to a total of 547 questionnaires. Focal and total cryotherapy patients had initially lower sexual function scores relative to AS (year 1 mean difference focal: -31.7, P <.001; total: -48.1, P <.001). Focal cryotherapy was associated with a more rapid improvement in sexual function. Both focal and total cryotherapy sexual function scores were not statistically significantly different from the AS cohort by postprocedural year 4. Very cold and moderate-cold temperatures led to initially lower sexual function scores relative to AS (year 1 very cold: -38.1, P <.001; moderate-cold: -30.7, P <.001). Moderate-cold temperature scores improved more rapidly than those of very cold temperature. Neither very cold nor moderate-cold temperatures had a statistically significant difference in sexual function scores relative to AS by postprocedural year 4. Urinary function and bowel habits were not significantly different between focal and total cryotherapy and between very cold and moderate-cold temperature groups. CONCLUSION:Focal cryotherapy and moderate-cold (≥-76°C) temperature were associated with favorable sexual function relative to total cryotherapy and very cold temperature, respectively. No significant differences in urinary function or bowel habits were observed between groups.
PMID: 29277657
ISSN: 1527-9995
CID: 3499142