This research study is studying MenHealth Mobile Uroflowmetry as a diagnostic tool for LUTS (lower urinary tract symptoms), a group of conditions involving the bladder, urinary sphincter, urethra and the prostate.

开始日期2020-08-18

申办/合作机构

MenHealth

[+1]

NCT03720223

/ Completed临床3期

Liposomal Bupivacaine To Control Post-Operative Pain Following Buccal Mucosal Graft Harvesting

This is a single blinded-randomized controlled trial that recruit male patients for substitution urethroplasty using buccal mucosal graft. The study investigators aim to assess the efficacy and safety of liposomal bupivacaine injection to the buccal graft harvest site on post-operative main score, morphine equivalence requirement and oral morbidities.

开始日期2015-01-20

申办/合作机构

Urology of Virginia PLLC

NCT02122341

/ TerminatedN/AIIT

Post FDA-Approval Clinical Evaluation of BackStopTM in Patients Undergoing Ureteroscopic Lithotripsy: A Prospective, Randomized Clinical Trial

The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration.

开始日期2014-04-01

申办/合作机构

University of Southern California

[+1]

100 项与 Urology of Virginia PLLC 相关的临床结果

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0 项与 Urology of Virginia PLLC 相关的专利（医药）

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项与 Urology of Virginia PLLC 相关的文献（医药）

2024-08-12·The Journal of Sexual Medicine

(215) THE OPTILUME® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: ROBUST III STUDY 4-YEAR INTERIM RESULTS

作者: Hagedorn, J ; Coutinho, K ; Te, A ; Carrier, S ; Demarco, D ; Aube-Peterkin, M ; Dunn, J ; Erickson, B ; Elliott, S ; Brandes, S ; Schlaifer, A ; Morey, A ; Robertson, K ; Virasoro, R ; Delong, J ; D'anna, R ; Levin, R ; Ehlert, M ; Chevli, K ; Cantrill, C

AbstractIntroductionThe ROBUST III study is a randomized controlled trial comparing the Optilume® Drug Coated Balloon (DCB) against direct visual internal urethrotomy (DVIU) or dilation. The Optilume® Drug Coated Balloon (DCB) is a dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. Outcomes after 4-year follow-up are presented here.ObjectiveTo determine long-term endpoints after Optilume® DCB including freedom from repeat treatment, International Prostate Symptom Score (IPSS), and peak urinary flow rate (Qmax).Methods127 subjects were randomized in a 2:1 fashion at 23 sites. Seventy-nine were treated with the DCB and 48 were treated with DVIU or dilation. Follow-up past 1 year was limited to those treated with the DCB. Eligibility criteria included adult males with anterior strictures with ≥2 prior treatments and stricture length ≤ 3 cm.ResultsSubjects randomized to receive the DCB had an average of 3.2 prior treatments and average stricture length of 1.6 cm (46% ≥ 2 cm), with 8/79 (10.1%) having penile strictures and 9/79 (11.4%) having prior pelvic radiation. IPSS significantly improved from 21.9 at baseline to 12.6 at 4 years. Qmax significantly improved from a baseline of 7.7 mL/sec to 13.2 mL/sec at 4 years. Freedom from repeat intervention for DCB subjects was estimated to be 71%. No late-onset treatment related adverse events were observed.ConclusionsThe Optilume® DCB continues to achieve significant improvements in symptoms, flow, and reintervention rates through 4 years post treatment.DisclosureYes, this is sponsored by industry/sponsor: Laborie.Clarification: Industry funding only - investigator initiated and executed study.

2024-08-01·Urology

The Role of Remote Diagnostics to Better Assess Uroflow Variability: Insights From Combining at Home Uroflows and Frequency Volume Charts From 19,868 Voids Using a Novel, Hand Held, Cellular Embedded Device

Article

作者: Shen, Jianzhao ; Kaplan, Steven A ; Molnar, Gabriela C ; Eure, Gregg R

OBJECTIVETo examine how representative 24-hour data collection is of the overall patient experience utilizing a home uroflow device in men with benign prostatic hyperplasia (BPH).MATERIALS AND METHODSHome uroflow data were collected with the iO Urology CarePath device from men at a single urology clinic and retrospectively analyzed. Void characteristics were summarized for data collected over 24 hours compared to data collected over several days or weeks with the device (overall study excludes the 24-hour data). A linear mixed-effects model was used to evaluate differences in average Qmax from voids collected during a single 24-hour period compared to the overall study.RESULTSA total of 486 men (mean age 67.4) used the device resulting in 465 included in the analysis with a total of 15,521 voids in the overall study and 4347 voids in the single-day analysis. Average Qmax from the model was 11.2 mL/s (95% CI: 10.80, 11.65) and 11.2 mL/s (95% CI: 10.81, 11.64) in the 24-hour and overall study groups, respectively. Both groups had similar between (20.3% vs 20.4%) and within-subject (12.0% vs 11.9%) variance. The difference in Qmax was not significantly different (P = .970). A subgroup analysis including voids >150 mL yielded similar results.CONCLUSIONData show variability in voiding parameters, but similar average Qmax collected in 24 hours as compared to several days/weeks. The combination of home uroflowmetry with frequency-volume chart information can provide objective data and a unique perspective on uroflow variability (UFV) for clinician review to support the development of individualized patient treatment plans.

2024-02-05·The Journal of Sexual Medicine

(064) The Optilume® Drug Coated Balloon for Recurrent Anterior Urethral Strictures: Robust III Study 3-year Interim Results

作者: Schlaifer, A ; Morey, A ; Robertson, K ; Delong, JM ; Coutinho, K ; Levin, R ; D'anna, R ; Desouza, E ; Dimarco, D ; Erickson, B ; Ehlert, MJ ; Dann, J ; Chevli, K ; Carrier, SC ; Cantrill, C ; Hagedorn, J ; Brandes, SB ; Krug, A ; Te, AE ; Elliott, S

AbstractIntroductionThe Optilume® Drug Coated Balloon (DCB) is a dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. Outcomes after 3-year follow-up are presented here.ObjectiveThe ROBUST III study is a randomized controlled trial comparing the Optilume® Drug Coated Balloon (DCB) against direct visual internal urethrotomy (DVIU) or dilation.Methods127 subjects were randomized in a 2:1 fashion at 23 sites. Seventy-nine were treated with the DCB and 48 were treated with DVIU or dilation. Follow-up past 1 year was limited to those treated with the DCB. Eligibility criteria included adult males with anterior strictures with ≥2 prior treatments and stricture length ≤3cm. Long-term endpoints included freedom from repeat treatment, International Prostate Symptom Score (IPSS), and peak urinary flow rate (Qmax).ResultsSubjects randomized to receive the DCB had an average of 3.2 prior treatments and average stricture length of 1.6cm (46% ≥2cm), with 8/79 (10.1%) having penile strictures and 9/79 (11.4%) having prior pelvic radiation. IPSS significantly improved from 22.0 at baseline to 11.3 at 3 years. Qmax significantly improved from a baseline of 7.7 mL/sec to 12.2 mL/sec at 3 years. Freedom from repeat intervention for DCB subjects was estimated to be 74%. No late-onset treatment related adverse events were observed.ConclusionsThe Optilume® DCB continues to achieve significant improvements in symptoms, flow, and reintervention rates through 3 years post treatment.DisclosureNo.

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100 项与 Urology of Virginia PLLC 相关的转化医学

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