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.

OBJECTIVE: To 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 METHODS: Home 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. RESULTS: A 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. CONCLUSION: Data 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.

Complications of GreenLight Laser vs Transurethral Resection of the Prostate for Treatment of Lower Urinary Tract Symptoms: Meta-analysis of Randomized Trials.

OBJECTIVE: To compare perioperative outcomes and complications between GreenLight and transurethral resection of the prostate (TURP) for benign prostatic hyperplasia. METHODS: A systematic review and random effects meta-analysis of randomized trials comparing GreenLight with TURP was completed. Primary outcomes included periprocedural milestones, 12 predefined complications, Clavien-Dindo class III-V complications, reoperations (all-cause), and a composite of reoperations and readmissions. Metaregression assessed the relationship between patient- and study-level factors with periprocedural outcomes and reoperation rates. RESULTS: The review included 13 randomized trials with 1757 patients (839 GreenLight; 918 TURP). Procedure time was 10 minutes (95% CI: 5 to 15; P < .001) longer with GreenLight, while catheterization time (mean difference=-1.3days; 95% CI: -1.7 to -0.9; P<.001) and hospital stay (mean difference=-2.1days; 95% CI: -2.5 to -1.7; P<.001) were shorter. Bleeding-related complications, including clot retention (risk ratio [RR]=0.12; 95% CI: 0.05 to 0.32; P<.001) and transfusion (RR=0.26; 95% CI: 0.12 to 0.58; P = .001), as well as sexual dysfunction (RR=0.66; 95% CI: 0.45 to 0.98; P = .04), were less frequent with GreenLight. All other complications occurred at similar frequencies between groups. The risks of reoperation (RR: 1.17; 95% CI: 0.82 to 1.66; P = .38) and reoperation or readmission (RR: 1.05; 95% CI: 0.76 to 1.44; P = .79) did not differ. CONCLUSION: GreenLight achieved shorter catheterization times and hospital stays with lower rates of sexual dysfunction and bleeding-related complications compared to TURP.

Safety, Perioperative, and Early Functional Outcomes of Vapor Incision Technique Using the GreenLight XPS 180 W System: Direct Comparison with Photoselective Vaporization of the Prostate.

OBJECTIVES: To compare perioperative parameters, safety, and short-term functional outcomes between GreenLight 180 W-XPS photoselective vaporization of the prostate (PVP) and vapor incision technique (VIT). MATERIALS AND METHODS: A total of 956 men were treated at five high-volume centers in Canada and the United States between 2000 and 2014 for benign prostatic hyperplasia. Perioperative parameters, complications, and early functional outcomes were retrospectively compared. One-to-one propensity score matching was performed to adjust for baseline differences between treatment groups. Subgroup stratified comparative analysis was performed according to preoperative prostate volume 80 cc or less vs greater than 80 cc on transrectal ultrasound (259 and 185 patients, respectively). RESULTS: VIT allowed greater energy delivery and energy density, but operative time and laser time were longer with greater use of MoXy fibers when compared with PVP (all p < 0.05). Improvements in outcomes at 6 months, including International Prostate Symptom Score, quality of life score, and uroflowmetry parameters, were significantly greater after VIT when compared with baseline. VIT was associated with significantly greater 6-month prostate-specific antigen (PSA) reduction (63% vs 50%, p = 0.01). No differences in intraoperative complications were observed between treatment groups. CONCLUSION: VIT is safe and efficacious, providing greater improvements in functional outcomes and PSA reduction at 6 months in comparison with PVP. These results reflect the larger amount of adenoma removed. Yet, it is associated with longer operative time and greater use of MoXy fibers. Long-term follow-up is needed to accurately assess functional outcomes and retreatment rates.

Office-based transurethral microwave thermotherapy using the TherMatrx TMx-2000.

BACKGROUND AND PURPOSE: Transurethral microwave thermotherapy (TUMT) is an effective therapy for symptomatic benign prostatic hyperplasia (BPH), but the trade-off between the magnitude of clinical improvement and side effects and patient tolerance has limited its appeal to patients and urologists. This study, using the TherMatrx TMx-2000, a TUMT device that directly heats the transition zone to greater than 50 degrees C, has been focused on resolving these issues and developing a truly office-based therapy that is well tolerated with a benign post-treatment course. PATIENTS AND METHODS: This study was multi-institutional and designed as a blinded, randomized, and sham-controlled trial. A series of 200 patients with an AUA Symptom Index (AUASI) of >12, a peak flow rate of <12 mL/sec, and cystoscopic evidence of BPH were randomized 2:1 (active to sham) and treated in seven physician offices under a Food and Drug Administration-supervised and audited premarket approval protocol. No intravenous sedation was used in any patient. Follow-up for the sham-treatment group was 3 months, at which time, patients could cross over to an active treatment. A total of 119 patients have completed 1-year follow-up. RESULTS: The active and sham groups were statistically identical at baseline. The 1-hour total treatment was extremely well tolerated using urethral lidocaine and oral medications; not a single prostate block or parental dose of medication was required. The active-treatment group demonstrated a statistically significant reduction (p < 0.05) in AUASI at 3 months compared with sham treatment, with an AUASI decrease from 22.4 to 12.4 (n = 124) for active v 22.9 to 17 for sham (n = 62). For the 119 patients in the active arm who have reached 12 months, the AUASI has fallen to 10.6 points (47.1% decrease), and the peak flow rate has increased 5.0 mL/sec (58.1%). Postprocedure catheterization was typically 2 or 3 days, and the 16.8% of patients who failed their first voiding trial all voided within 1 week. No major adverse events such as stricture, rectal findings, or ejaculatory changes have been reported. CONCLUSIONS: This study demonstrates that the TherMatrx TMx-2000 TUMT effectively treats symptomatic BPH in the physician office with minimal morbidity.