BACKGROUND:Although germline genetic testing can inform medical management for patients with prostate cancer (PCa), data are limited regarding patient-reported outcomes (PROs) after germline genetic testing for PCa. Recall and comprehension of germline genetic testing results, uptake of post-test clinical recommendations, and psychological impact of germline genetic testing among patients with PCa were evaluated. METHODS:This is a secondary analysis of data from the PROCLAIM trial. PROs were analyzed overall and by germline genetic testing results. Differences between groups were determined by two-tailed Fisher's exact test with significance set at p < 0.05. RESULTS:Among 494 patients with informative survey responses, 60% and 71% accurately recalled and interpreted their germline genetic testing results, respectively, with the highest rates among patients with negative results and the lowest among those with variant of uncertain significance-only (VUS) results. Among 42/55 (76%) patients with positive results for whom clinicians made germline genetic testing-informed recommendations, 39 (93%) completed or planned to complete >1 clinical recommendation. Conversely, no further recommendations were made for 160/221 (72%) and 211/218 (97%) patients with VUS and negative results, respectively. However, 57% (213/371) of these patients indicated that they or their family members intended to pursue clinical management strategies that were not recommended by their clinicians. Of the patients who responded to the survey, >90% of patients reported no post-germline genetic testing increase in their level of concern for themselves or their family members. CONCLUSION:germline genetic testing for patients with PCa did not cause appreciable psychological harm to the tested patients. Furthermore, patients with positive results had a high uptake of clinician-recommended management strategies. Of note, there were inconsistencies in the understanding of VUS results, with some clinicians making recommendations not warranted by personal/family history; conversely, some patients pursued management strategies not recommended by their clinicians. This suggests that educational efforts are needed in the communication of germline genetic testing results and clinical recommendations to patients.

You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-13 PRELIMINARY RCT ANALYSIS OF MINIMALLY INVASIVE SURGERY VS. MEDICATION IN THE INITIAL TREATMENT OF BPH-ASSOCIATED LUTS Philip Brodak, Shadi Tarazi, Prithipal Sethi, Michael Trotter, Dean Elterman, Sheldon Freedman, Sean Heron, Nilay Gandhi, Todd Bertoch, Gregg Eure, Wiliam Brad Roth, Thomas Mueller, Brian Mazzarella, and Claus Roehrborn Philip BrodakPhilip Brodak , Shadi TaraziShadi Tarazi , Prithipal SethiPrithipal Sethi , Michael TrotterMichael Trotter , Dean EltermanDean Elterman , Sheldon FreedmanSheldon Freedman , Sean HeronSean Heron , Nilay GandhiNilay Gandhi , Todd BertochTodd Bertoch , Gregg EureGregg Eure , Wiliam Brad RothWiliam Brad Roth , Thomas MuellerThomas Mueller , Brian MazzarellaBrian Mazzarella , and Claus RoehrbornClaus Roehrborn View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS) are initially treated with medical therapy or watchful waiting; medical therapy non-adherence is high due to low efficacy, sexual dysfunction, and undesirable adverse events. The Prostatic Urethral Lift (PUL) and other minimal invasive surgical therapies (MISTs) offer durable relief from symptoms, superior early patient experience and a favorable safety profile compared to TURP while preserved bladder health compared to alpha therapy alone or watchful waiting. The IMPACT RCT compares PUL using the UroLift System to medical therapy, with a focus on patient experience and efficacy through 3 months. METHODS: IMPACT is a prospective, multi-center, two-arm, 1:1 non-blinded RCT in BPH patients treated with PUL or medication (tamsulosin 0.4 mg daily) comparing safety, efficacy, and post-procedural patient experience. BPH symptom change at 3 months served as the primary endpoint, with quality-of-life, treatment goal achievement, satisfaction, sexual function, adverse events, and medication adherence as additional endpoints. This preliminary analysis reports key data gathered to date. RESULTS: 88 PUL and 112 medication subjects were available for preliminary analysis. Baseline demographics were similar between treatment groups. PUL subjects demonstrated more IPSS improvements of 39.1% and 46.8% at 1 and 3 months, respectively, compared to 16.9% and 14.2% for medication. QoL at 1 and 3 months for PUL patients improved 39.3% and 47.9%, compared to 10.2% and 7.8% for medication subjects (Table 1). Sexual function improvements (ejaculatory/erectile function, bother) were greater for PUL compared to medication subjects. PUL patients reported a more positive treatment perception at 1 and 3 months compared to medication. Baseline treatment goals were similar for PUL and medication subjects; overall goal achievement and highly rated goals (Table 1) were higher for PUL than medication at 1 and 3 months. CONCLUSIONS: IMPACT is the first head-to-head RCT comparing any MIST to medication in the treatment of LUTS secondary to BPH. Preliminary data suggests PUL offers greater improvements in quality-of-life, symptoms and patient satisfaction. Source of Funding: Teleflex, Inc © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5S2May 2024Page: e9 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Philip Brodak More articles by this author Shadi Tarazi More articles by this author Prithipal Sethi More articles by this author Michael Trotter More articles by this author Dean Elterman More articles by this author Sheldon Freedman More articles by this author Sean Heron More articles by this author Nilay Gandhi More articles by this author Todd Bertoch More articles by this author Gregg Eure More articles by this author Wiliam Brad Roth More articles by this author Thomas Mueller More articles by this author Brian Mazzarella More articles by this author Claus Roehrborn More articles by this author Expand All Advertisement PDF downloadLoading ...

You have accessJournal of UrologyProstate Cancer: Markers I (MP41)1 May 2024MP41-08 UTILIZING PATIENT-REPORTED OUTCOMES TO ASSESS THE IMPACT OF UNIVERSAL GERMLINE GENETIC TESTING FOR PROSTATE CANCER Neal Shore, Christopher M. Pieczonka, Sean Heron, Mukaram Gazi, David J. Cahn, Laurence Belkoff, Aaron D. Berger, Brian Mazzarella, David Morris, Joseph Veys, Richard Bevan-Thomas, Alexander Engelman, Paul Dato, Robert Cornell, David R. Wise, Mary Kay Hardwick, Kathryn E. Hatchell, Brandie Heald, Robert L. Nussbaum, Sarah M. Nielsen, and Edward D. Esplin Neal ShoreNeal Shore , Christopher M. PieczonkaChristopher M. Pieczonka , Sean HeronSean Heron , Mukaram GaziMukaram Gazi , David J. CahnDavid J. Cahn , Laurence BelkoffLaurence Belkoff , Aaron D. BergerAaron D. Berger , Brian MazzarellaBrian Mazzarella , David MorrisDavid Morris , Joseph VeysJoseph Veys , Richard Bevan-ThomasRichard Bevan-Thomas , Alexander EngelmanAlexander Engelman , Paul DatoPaul Dato , Robert CornellRobert Cornell , David R. WiseDavid R. Wise , Mary Kay HardwickMary Kay Hardwick , Kathryn E. HatchellKathryn E. Hatchell , Brandie HealdBrandie Heald , Robert L. NussbaumRobert L. Nussbaum , Sarah M. NielsenSarah M. Nielsen , and Edward D. EsplinEdward D. Esplin View All Author Informationhttps://doi.org/10.1097/01.JU.0001008896.93851.5b.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Germline genetic testing (GGT) affords prostate cancer (PCa) patients (pts) opportunities for targeted therapies, personalized management, and cascade family testing. Patient-reported outcomes (PRO) evaluate physician effectiveness in promoting pt test comprehension and clinical decision making, which are essential components of GGT. PROs from a large prospective PCa study were analyzed. METHODS: The PROCLAIM trial (NCT05447637) enrolled unselected PCa pts from 15 US urology practices. Pts underwent 84-gene GGT at Invitae® with PROs collected >1-month post-GGT. PROs were analyzed overall and by GGT result: positive (≥1 pathogenic germline variant), negative, and variant(s) of uncertain significance (VUS). Differences in proportions were determined using two-tailed Fisher's exact test and significance was set at <0.05. RESULTS: Half (494/982) of study pts had informative PRO responses, and were: 86% White, 84% non-metastatic, median age 70 years. 11% of pts had positive results, 44% negative and 45% VUS. Negative pts were significantly more likely than those with positive or VUS results to accurately recall their result (80% vs. 64% and 40%, respectively; p<0.0192) and to correctly understand if their result was associated with cancer risk or not (86% vs. 67% and 60%; p<0.0034). Compared to pts with positive or negative results, pts with VUS were significantly less likely to have both accurate recall and understanding of their result (22% vs. 63% and 86%, p<0.0001). Among 170 pts who reported receiving >1 clinical recommendation from their physician, most (76%) had completed or planned to complete >1 of them (Table 1). Positive pts who complied with recommendations were more likely to have demonstrated comprehension of their GGT result compared to pts who were non-compliant (p=0.006). Most pts reported that their GGT result either reduced (42%) or did not impact (51%) their concern regarding their PCa diagnosis, treatment or followup. 7% of all patients, and 18% of positive patients, reported increased concern. CONCLUSIONS: Implementation of universal GGT for PCa did not appear to cause undue harm to pts and resulted in adherence to clinical recommendations. There still remains educational opportunities to improve how test results and recommendations are communicated to pts. Source of Funding: Invitae Corp © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e675 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Neal Shore More articles by this author Christopher M. Pieczonka More articles by this author Sean Heron More articles by this author Mukaram Gazi More articles by this author David J. Cahn More articles by this author Laurence Belkoff More articles by this author Aaron D. Berger More articles by this author Brian Mazzarella More articles by this author David Morris More articles by this author Joseph Veys More articles by this author Richard Bevan-Thomas More articles by this author Alexander Engelman More articles by this author Paul Dato More articles by this author Robert Cornell More articles by this author David R. Wise More articles by this author Mary Kay Hardwick More articles by this author Kathryn E. Hatchell More articles by this author Brandie Heald More articles by this author Robert L. Nussbaum More articles by this author Sarah M. Nielsen More articles by this author Edward D. Esplin More articles by this author Expand All Advertisement PDF downloadLoading ...

PURPOSE:Identification of pathogenic germline variants in patients with prostate cancer can help inform treatment selection, screening for secondary malignancies, and cascade testing. Limited real-world data are available on clinician recommendations following germline genetic testing in patients with prostate cancer. MATERIALS AND METHODS:Patient data and clinician recommendations were collected from unselected patients with prostate cancer who underwent germline testing through the PROCLAIM trial. Differences among groups of patients were determined by 2-tailed Fisher's exact test with significance set at P < .05. Logistic regression was performed to assess the influence of test results in clinical decision-making while controlling for time of diagnosis (newly vs previously diagnosed). RESULTS:Among 982 patients, 100 (10%) were positive (≥1 pathogenic germline variant), 482 (49%) had uncertain results (≥1 variant of uncertain significance), and 400 (41%) were negative. Patients with positive results were significantly more likely than those with negative or uncertain results to receive recommendations for treatment changes (18% vs 1.4%, P < .001), follow-up changes (64% vs 11%, P < .001), and cascade testing (71% vs 5.4%, P < .001). Logistic regression demonstrated that positive and uncertain results were significantly associated with both changes to treatment and follow-up (P < .001) when controlling for new or previous diagnosis. CONCLUSIONS:Germline genetic testing results informed clinical recommendations for patients with prostate cancer, especially in patients with positive results. Higher than anticipated rates of clinical management changes in patients with uncertain results highlight the need for increased genetic education of clinicians treating patients with prostate cancer.

10607 Background: Germline genetic testing (GGT) affords prostate cancer (PCa) patients (pts) opportunities for targeted therapies, prevention and cascade testing. Patient-reported outcomes (PRO) can evaluate physician effectiveness in promoting patient test comprehension and clinical decision making, which are critical to realize the benefits of GGT. PROs from a large PCa GGT study among urologists were analyzed. Methods: A prospective study enrolled unselected PCa pts from 15 primarily community urology practices. Pts underwent 84-gene GGT, with PROs collected via electronic or paper surveys >1-month post GGT. Differences in proportions were determined using two-tailed Fisher’s exact test and significance was set at <0.05. Results: PROs were completed by 561/982 (57%) pts (85% white, 82% non-metastatic, median age at testing 70 years). 59 (11%) pts had positive results, 247 (44%) negative and 255 (46%) variants of uncertain significance (VUS). 72% accurately recalled their result (range, 50% [VUS]-93% [negative]). 66% of positive pts, 80% negative and 54% VUS correctly understood if their result was associated with cancer risk or not. 72% of positive pts had or planned to complete ≥1 physician recommendations, significantly more than negative or VUS pts (Table). Most pts reported that their test result reduced their concerns (40%) or did not impact their level of concern (52%) regarding their PCa diagnosis, treatment or followup. 19% of positive pts reported increased concern. Conclusions: GGT for PCa was deployed without causing undue concern and resulted in adherence to physician recommendations. Still, there is room for improvement in how test results (especially VUS) and recommendations are communicated to pts. [Table: see text]

Background: Prostate cancer (PCa) patients with pathogenic/likely pathogenic germline variants (PGVs) in cancer predisposition genes may be eligible for U.S. Food and Drug Administration-approved targeted therapies, clinical trials, or enhanced screening. Studies suggest that eligible patients are missing genetics-informed care due to restrictive testing criteria. Objective: To establish the prevalence of actionable PGVs among prospectively accrued, unselected PCa patients, stratified by their guideline eligibility. Design, setting, and participants: Consecutive, unselected PCa patients were enrolled at 15 sites in the USA from October 2019 to August 2021, and had multigene cancer panel testing. Outcome measurements and statistical analysis: Correlates between the prevalence of PGVs and clinician-reported demographic and clinical characteristics were examined. Results and limitations: Among 958 patients (median [quartiles] age at diagnosis 65 [60, 71] yr), 627 (65%) had low-or intermediate-risk disease (grade group 1, 2, or 3). A total of 77 PGVs in 17 genes were identified in 74 patients (7.7%, 95% confidence interval [CI] 6.2-9.6%). No significant difference was found in the prevalence of PGVs among patients who met the 2019 National Comprehensive Cancer Network Prostate criteria (8.8%, 43/486, 95% CI 6.6-12%) versus those who did not (6.6%, 31/472, 95% CI 4.6-9.2%; odds ratio 1.38, 95% CI 0.85-2.23), indicating that these criteria would miss 42% of patients (31/74, 95% CI 31-53%) with PGVs. The criteria were less effective at predicting PGVs in patients from under-represented populations. Most PGVs (81%, 60/74) were potentially clinically actionable. Limitations include the inability to stratify analyses based on individual ethnicity due to low numbers of non-White patients with PGVs. Conclusions: Our results indicate that almost half of PCa patients with PGVs are missed by current testing guidelines. Comprehensive germline genetic testing should be offered to all patients with PCa. Patient summary: One in 13 patients with prostate cancer carries an inherited variant that may be actionable for the patient's current care or prevention of future cancer, and could benefit from expanded testing criteria. (c) 2023 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).

10500 Background: Approximately 10-15% of prostate cancer (PCa) patients (pts) have a pathogenic germline variant (PGV). Identification of a PGV has important implications affecting decisions regarding cancer screening, treatment selection, and family cascade testing. There exists limited data documenting real world recommendations post germline genetic testing (GGT). This study was designed to collect clinician reported outcomes from PCa pts who underwent GGT. Methods: An IRB-approved, nationwide, prospective registry recruited unselected PCa pts from 15 community and academic urology practices. Pts underwent an 84-gene panel test, with clinical outcomes collected via clinician-completed case report forms > 1-month post GGT. Statistical significance was determined by two-tailed Fisher’s exact test. Results: 982 predominantly white (75.9%), non-metastatic (80.7%) males with PCa were recruited; 56.9% met National Comprehensive Cancer Network (NCCN) GGT criteria. Average age was 65.3 years at PCa diagnosis. PGVs, most commonly CHEK2 (17) and BRCA2 (10), were identified in 100 (10.2%) pts; 34 (34%) of these did not meet NCCN GGT criteria. Among PGV positive pts, 241 recommendations were made (Table). They were more likely to have changes to treatment (p < 0.0001), follow up (p < 0.0001) and cascade testing recommendations (p < 0.0001) than those with negative/variant of uncertain significance (VUS) results. There were no significant differences in changes to treatment (p = 0.4471) or follow up (p = 0.861) for pts who met NCCN criteria versus those who did not. 7 pts with PGVs received targeted therapy or were referred to a clinical trial. 5 pts with VUS results were also referred to a clinical trial. Among these 12 pts, 6 (50%, 2 CHEK2 PGV, 1 ATM PGV, 1 VUS each ATM, BLM, CHEK2) did not meet NCCN GGT criteria. Referral to a genetic counselor was the most common follow up recommendation for those with PGV (38 patients, 38%) and VUS results (66, 13.7%). The most commonly reported impact to health outcomes for those with negative results was knowledge/reassurance (38, 7.88%). Conclusions: This study showed that GGT did influence PCa pts care. Appropriately, pts with PGVs received a greater number of recommendations for relatives, changes to follow up and treatment. [Table: see text]

10504 Background: Pathogenic/likely pathogenic (P/LP) germline genetic variants are estimated to occur in 10-15% of all prostate cancer (PCa) patients. However, genetic testing for PCa patients is underutilized, partially due to complicated and restrictive testing guidelines developed at a time when the cost of testing was high. We conducted a study based in community urology clinics to determine the incidence of P/LP variants in PCa patients who met and did not meet the NCCN 2019 PCa germline genetic testing criteria. Methods: An IRB-approved, multicenter, prospective registry was initiated with 15 community and academic urologists nationwide. Eligibility criteria included patients with a PCa diagnosis unselected for personal or family history, stage or histology who had not been previously tested. Consecutive patients ages 18-90 were consented and underwent an 84-gene germline panel test. HIPAA-compliant electronic case report forms distributed to clinician collected information on patient diagnoses, NCCN testing criteria, and results-based recommendations. Results: To date, 640 enrolled patients have genetic testing results available. Overall, 69 (10.8%) patients had 72 P/LP variants detected, 15% of which were in BRCA1/2. Of the 532 patients for whom we have clinician-reported data, 293 (55%) met NCCN criteria and 239 (45%) did not. Median age was 70 (range 44-90). Overall, 11.1% (59/532) of patients with clinician-reported data had a P/LP variant. 36 (12.3%) of patients who met NCCN criteria and 23 (9.6%) of patients who did not meet criteria had a P/LP variant. The difference in P/LP rate between the two groups was not statistically significant (p=0.33). If only a conservative 12-gene PCa panel was considered, P/LP yield was 5.5% (29/532), with 8 (28%) of these patients missed by guidelines. Stratification by self-reported ethnicity was: 76% White/Caucasian (52 patients w/ P/LP), 18% Black/African American (2 patients w/ P/LP), and <5% each of Hispanic or Asian. Conclusions: There was no statistically significant difference in the yield of P/LP variants between patients who met and those who did not meet NCCN PCa guidelines, reinforcing that a significant number of P/LP variants are missed if NCCN guidelines are required for genetic testing. Expanded panel testing yields more medically actionable P/LP variants than testing BRCA1/2 alone or PCa panels with 12 genes. While 18% of the cohort was Black/African American, there was a lower P/LP rate (2%) relative to other groups, indicating that more research is needed to understand genetic variation in underrepresented populations with PCa.

Pathogenic/Likely pathogenic (P/LP) germline variants occur in 10-15% of all prostate cancer (PCa) patients. However, complex and restrictive testing criteria lead to underutilization of genetic testing. A multi center prospective observational study was conducted to determine the incidence of P/LP variants in PCa patients who met criteria (IC) and did not meet (out of criteria-OOC) personal/family history based genetic testing criteria (e.g. ESMO Clinical Practice Guidelines).

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II1 Apr 2017MP27-17 3 YEAR RESULTS OF A PROSPECTIVE MULTI-CENTER STUDY ON LOCAL ANESTHESIA FOR THE PROSTATIC URETHRAL LIFT (PUL) Steven Gange, Neal Shore, Sheldon Freedman, William Moseley, Sean Heron, Ronald Tutrone, Thomas Brown, and Jack Barkin Steven GangeSteven Gange More articles by this author , Neal ShoreNeal Shore More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , William MoseleyWilliam Moseley More articles by this author , Sean HeronSean Heron More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Thomas BrownThomas Brown More articles by this author , and Jack BarkinJack Barkin More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.809AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostatic Urethral Lift (PUL) is a minimally invasive procedure for lower urinary tract symptoms (LUTS) that may be conducted in the office setting. In order to characterize procedure tolerance under local anesthesia, peri-operative recovery, and long-term outcomes, PUL was studied in a multi-center, prospective, non-randomized trial. METHODS At 7 US centers, 51 men with International Prostate Symptom Score (IPSS)>12, peak flow rate = 12mL/s, and prostate volume < 80cc were treated with PUL wherein UroLift' implants were transurethrally placed into the lateral lobes to enlarge the urethral lumen. Patient experience was measured via validated instruments including pelvic pain visual analog scale (VAS), Quality of Recovery VAS (QoR), Patient General Impression Index (PGI-I), Work Productivity and Activity Impairment Questionnaire (WPAI). RESULTS All procedures were well tolerated under local anesthesia. Symptom relief was significant by 1 month (IPSS 48%, QoL 44%) and sustained through 3 years (IPSS 42%, QoL 50%). 80% of patients were catheter free after PUL and the average for all patients was less than one day. There was no de novo, sustained occurrence of ejaculatory or erectile dysfunction. By one month, 86% of subjects achieved high quality recovery per QoR, 90% reported improvement through PGI-I, 96% had returned to pre-operative activity, 100% of employed subjects had returned to work. Average erectile function scores did not change, and both ejaculatory function and bother were improved (p<0.001). CONCLUSIONS The PUL procedure is well tolerated under local anesthesia, rarely requires postoperative catheterization, and is associated with high quality recovery experiences. In addition, the results of this study indicate that PUL provides durable symptom relief to patients, as IPSS and quality of life scores remain significantly improved at 3 years. PUL offers patients a minimally invasive option for rapid, sustained LUTS relief and preserved sexual function. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e335-e336 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Steven Gange More articles by this author Neal Shore More articles by this author Sheldon Freedman More articles by this author William Moseley More articles by this author Sean Heron More articles by this author Ronald Tutrone More articles by this author Thomas Brown More articles by this author Jack Barkin More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The prostatic urethral Lift (PUL) procedure offers a novel treatment for men with lower urinary tract obstructive symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Most patients who seek LUTS/BPH treatment choose the intervention that offers the expectations of a significant improvement in quality of life and the least chance of short or long term morbidity. We report the results of a prospective, non-randomized study designed to further characterize the perioperative subject experience with the PUL procedure.The PUL procedure employs permanent implants to mechanically pull the prostatic lateral lobes apart. Subjects were ≥ 50 years old with International Prostate Symptom Score (IPSS) ≥ 12, peak flow rate ≤ 12 mL, and prostate volume between 30 cc and 80 cc. Subject experience through 1 month was characterized by validated instruments designed to assess quality of recovery, work productivity, activity impairment, symptom response, quality of life, flow rate and sexual function.Fifty-one subjects were treated without any serious adverse events. No case was abandoned or postponed due to subject discomfort. By 1 month, 86% of subjects achieved high quality recovery as measured by a score of ≥ 80 on the Quality of Recovery Visual Analog Scale. Ninety percent of subjects reported improvement in their condition and 75% of subjects would recommend the procedure to a friend. Symptom response, flow rate improvement, and sexual function preservation were comparable to published studies.The PUL procedure was tolerated under local anesthesia, rarely required postoperative catheterization, and offered rapid LUTS relief with minimal associated morbidity. The study further allows urologists to advise patients regarding post-procedural expectations and side effects, inclusive of symptomatic benefit.

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II1 Apr 2014MP71-07 PROSPECTIVE SINGLE ARM STUDY TO CHARACTERIZE PROSTATIC URETHRAL LIFT PATIENT EXPERIENCE Neal Shore, Sheldon Freedman, Steven Gange, William Moseley, Sean Heron, B. Thomas Brown, and Ronald Tutrone Neal ShoreNeal Shore More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Steven GangeSteven Gange More articles by this author , William MoseleyWilliam Moseley More articles by this author , Sean HeronSean Heron More articles by this author , B. Thomas BrownB. Thomas Brown More articles by this author , and Ronald TutroneRonald Tutrone More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2166AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To characterize the subject experience and evaluate early response to the Prostatic Urethral Lift (PUL) through a multi-center, prospective, non-randomized study. METHODS 51 men with AUASI > 12, Qmax ≤ 12mL/s, and prostate volume < 80 cc were treated with PUL at 7 US centers. PUL involves placing permanent transprostatic UroLift® implants into the lateral lobes of the prostate to enlarge the urethral lumen. Patient experience during the procedure was captured at specific points through a pelvic pain visual analog scale. Post operative experience was measured via validated instruments Quality of Recovery VAS (QOR), Patient General Impression Index (PGI-I), Work Productivity and Activity Impairment Questionnaire (WPAI), AUA Symptom Index (AUASI), AUASI Quality of Life (QoL), Benign Prostatic Hyperplasia Impact Index (BPH II), as well as urinary flow rate, sexual function, and adverse events. RESULTS All procedures were completed with local anesthesia. Adverse events related to PUL were typically mild to moderate and resolved by 2 weeks. There were no reported occurrences of ejaculatory or erectile dysfunction. By one month, 86% of subjects were recovered (>80 QOR), 90% reported improvement through PGI-I, 96% had returned to pre-operative activity, 100% of employed subjects had returned to work, and 75% of subjects would recommend the procedure to a friend. Subjects experienced improvement in AUASI (10.5), QoL (2.1), and BPH II (3.4) at one month assessment (p-Values < 0.001, Table 1). Peak urinary flow rate (Qmax) improved 3.1 ml/s (Table 1). Average erectile function scores did not change significantly, and both ejaculatory function and bother were improved (Table 1). CONCLUSIONS PUL is tolerated under local anesthesia and can allow patients to quickly return to pre-operative activity. The procedure may provide rapid symptom relief and objective flow improvements while preserving sexual function. Table 1: Procedure details and patient experience assessments. Mean(SD)[range] Implants per Patient 3.7 (1.1) [2 to 6] Prostate Volume (cc) 41.3 (11.6) [30.0 to 77.3] VAS: Flexible Cystoscopy 3.0 (2.2) [0 to 9] VAS: Rigid Cystoscopy 4.8 (2.9) [0 to 10] VAS: UroLift Implantation 5.0 (3.0) [0 to 10] Return to Preoperative Activity* (days) 5.1 (5.8) [0 to 30] Return to Work (days) 2.8 (3.7) [0 to 17] At 1 Month: WPAI: % Work Missed 0% (0%) [0%] WPAI: % Overall Work Impairment 3% (9%) [0 to 40%] WPAI: % Activity Impairment 8% (19%) [0 to 100%] AUASI Change -10.5 (7.4) [-27 to 8] , p<0.001 QOL Change -2.1 (1.9) [-6 to 2] , p<0.001 BPH Impact Index Change -3.4 (3.6) [-11 to 7] , p<0.001 Qmax Change 3.1 (4.6) [-4.8 to 19], p<0.001 Erectile Function Change (IIEF-5) -0.5 (6.4) [-21 to 18], p 0.6 Ejaculatory Function Change (MSHQ-EjD function) 1.6 (2.8) [-1 to 4], p 0.002 Ejaculatory Bother Change (MSHQ-EjD bother) -0.8 (1.4) [-5 to 2], p 0.003 *2 subjects (4%) had not reported return to preoperative activity by the 1 month visit © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e792 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Neal Shore More articles by this author Sheldon Freedman More articles by this author Steven Gange More articles by this author William Moseley More articles by this author Sean Heron More articles by this author B. Thomas Brown More articles by this author Ronald Tutrone More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

You have accessJournal of UrologyModerated Poster, Wednesday, May 25, 2005, 10:00 am - 12:00 pm1 Apr 20051565: Initial Results of a Randomized Multi-Center Trial Comparing the Efficacy and Safety of Indigo Optima Laser Treatment with Tamsulosin in Men with LUTS and BPH Claus G. Roehrborn, Eugene Y. Rhee, Scott D. Miller, Michael K. Brawer, Sean P. Heron, Herbert C. Ruckle, Peter Loisides, and Sheldon J. Freedman Claus G. RoehrbornClaus G. Roehrborn More articles by this author , Eugene Y. RheeEugene Y. Rhee More articles by this author , Scott D. MillerScott D. Miller More articles by this author , Michael K. BrawerMichael K. Brawer More articles by this author , Sean P. HeronSean P. Heron More articles by this author , Herbert C. RuckleHerbert C. Ruckle More articles by this author , Peter LoisidesPeter Loisides More articles by this author , and Sheldon J. FreedmanSheldon J. Freedman More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(18)35699-4AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "1565: Initial Results of a Randomized Multi-Center Trial Comparing the Efficacy and Safety of Indigo Optima Laser Treatment with Tamsulosin in Men with LUTS and BPH." The Journal of Urology, 173(4S), p. 424 © 2016 by American Urological AssociationFiguresReferencesRelatedDetails Volume 173Issue 4SApril 2005Page: 424 Advertisement Copyright & Permissions© 2016 by American Urological AssociationMetricsAuthor Information Claus G. Roehrborn More articles by this author Eugene Y. Rhee More articles by this author Scott D. Miller More articles by this author Michael K. Brawer More articles by this author Sean P. Heron More articles by this author Herbert C. Ruckle More articles by this author Peter Loisides More articles by this author Sheldon J. Freedman More articles by this author Expand All Advertisement Loading ...