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.

Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results.

PURPOSE: We report 5-year safety and efficacy outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia and large-volume prostate glands. MATERIALS AND METHODS: A total of 101 men with moderate to severe benign prostatic hyperplasia symptoms and prostate volumes between 80 and 150 mL underwent a robotic-assisted Aquablation procedure in a prospective multicenter international trial (NCT03123250). Herein we report the final 5-year results. RESULTS: The study successfully met its safety and efficacy performance goal, which was based upon transurethral resection of the prostate outcomes typically done in smaller prostates, at 3 months. Mean prostate volume was 107 mL (range 80-150) at baseline. Patient symptoms showed a significant improvement where the mean (SD) International Prostate Symptom Score of 22.6 (6.4) at baseline to 6.8 (4.6) at 5 years, resulting in a change score of 15.9 (7.7, P < .001). Uroflowmetry measurements also demonstrated improvement where the mean maximum urinary flow rate increased from 8.6 (SD 3.4) to 17.1 (9.8) mL/s at 5 years, resulting in a change score of 9.2 (11.1) mL/s at 5 years (P < .001). A regression analysis evaluating change in PSA as a function of baseline PSA across all time points out to 5 years resulted in a 50% reduction. A prespecified subgroup analysis using a baseline prostate volume cutoff of 100 mL showed no difference in efficacy outcomes through 5 years. Freedom from a secondary benign prostatic hyperplasia procedure at 5 years was 96.3% based on Kaplan-Meier. CONCLUSIONS: At 5-years of prospective follow-up, the Aquablation procedure was shown to be safe with durable efficacy and low rates of retreatment in men with large prostates (80-150 mL).

Prostatic Urethral Lift for Obstructive Median Lobes: Consistent Results Across Controlled Trial and Real-World Settings.

Introduction: The evidence for prostatic urethral lift (PUL), in treating lower urinary tract symptoms/benign prostatic hyperplasia (BPH) in men with obstructive median lobes (OMLs), has grown. In this study, we present the first detailed comparison of outcomes between OML patients treated with PUL in controlled and real-world settings to relevant comparators (subjects treated with transurethral resection of the prostate [TURP] and sham in randomized controlled trials [RCTs]) to demonstrate similar symptom, safety, and patient experience outcomes. Materials and Methods: Symptom and safety outcomes and patient satisfaction were compared through 12 months among controlled PUL studies: BPH6 RCT (35 men randomized to TURP); L.I.F.T. pivotal RCT in subjects with lateral lobe obstruction (66 subjects randomized to sham) and MedLift, an U.S. Food and Drug Administration-approved Investigational Device Exemption (IDE) extension of the L.I.F.T. trial (45 men with OML). Symptom improvement, catheterization, and adverse event rates were compared between MedLift subjects and OML patients (n = 187) from the large real-world retrospective (RWR) study of PUL filtered on baseline characteristics to approximate the MedLift population. Results: Posttreatment, International Prostate Symptoms Score (IPSS) improvement for MedLift subjects was 170% greater compared with sham at 3 months with significantly better quality of life (QoL), Qmax, and benign prostatic hyperplasia impact index (BPHII). Compared with TURP, MedLift IPSS and QoL improved significantly better at 1 and 3 months and with superior ejaculatory function scores at all time points after PUL. IPSS, QoL, postvoid residual (PVR), and Qmax outcomes were equivalent between MedLift and RWR OML groups at 3, 6, and 12 months. RWR OML patients did not experience higher rates of overall adverse events compared with MedLift. Conclusion: Controlled and real-world outcomes confirm PUL is a safe and effective treatment for BPH patients with and without OML.

Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial.

OBJECTIVE: To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. METHODS: Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. RESULTS: The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien-Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien-Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction. CONCLUSIONS: Aquablation is safe and effective in treating men with larger prostates (80-150 mL), without significant increase in procedure or resection time.

Evaluation of Surgical Outcomes with Photoselective GreenLight XPS Laser Vaporization of the Prostate in High Medical Risk Men with Benign Prostatic Enlargement: A Multicenter Study.

OBJECTIVE: To evaluate the safety and short-term outcomes of photoselective vaporization of the prostate (PVP) using GreenLight XPS™ in treatment of high medical risk (HMR) men. METHODS: A multicenter retrospective analysis of 941 men who underwent PVP between August 2010 and August 2014 was performed. Patients were considered HMR if they had an American Society of Anesthesiologists physical status score ≥3. Postoperative adverse events, unexpected postoperative medical provider visits after intervention, and functional urinary outcomes were examined. RESULTS: HMR men (n = 273) were older (mean age 72.3 ± 8.1 years vs 67.1 ± 9 years, p ≤ 0.01), had larger prostate volumes (82.8 ± 48.2 g vs 73.7 ± 49.4 g, p < 0.01), and were more likely to be on anticoagulant and antiplatelet medications (all p ≤ 0.01). Moreover, overall operative time (65 ± 35.1 minutes vs 53.9 ± 24.9 minutes), energy delivered (313.4 ± 207 kJ vs 258 ± 164 kJ), and energy density used (4.2 ± 3.8 kJ/g vs 3.8 ± 3 kJ/g) were greater in the HMR group (all p ≤ 0.05). Although HMR men were more often treated in a hospital setting (p ≤ 0.01), there were no differences in intraoperative adverse events. At 6 months, both groups had notable improvements from baseline for International Prostate Symptom Score, quality of life due to urinary symptoms, maximum urinary flow rate, postvoid residual urine volume, and prostate-specific antigen. Regarding safety, the two groups had comparable 90-day Clavien-Dindo complication rates, numbers of urgent care visits, and numbers of outpatient consultations. HMR men, however, had more hospital readmissions within 90 days postsurgery (3.7% vs 1.3%; p = 0.04). CONCLUSIONS: Despite older age, greater comorbidity, and significant use of anticoagulants, HMR men who undergo photoselective vaporization benefit from symptom improvement and show no clinical difference in adverse event profiles. GreenLight-XPS produces similar short-term outcomes in patients with significant comorbidities when compared with healthy patients.

Comparison of GreenLight laser and transurethral resection of the prostate baseline characteristics and outcomes: lessons learned from the Clinical Research Office of the Endourological Society GreenLight Laser Study.

BACKGROUND: To compare baseline characteristics and outcomes of patients undergoing GreenLight laser vaporization (GL) or transurethral resection of the prostate (TURP) in a real life setting. METHODS: In this prospective observational cohort, the Clinical Research Office of the Endourological Society (CROES) collected data of consecutive GL or TURP treated patients. Treatment involved one of three GL laser powers (80 W, 120 W or 180 W) based on availability in each participating centre, or TURP. Data on baseline characteristics as well as functional measures were collected at three time points: 6-12 weeks, 6, and 12months after surgery. Functional measures included urinary flow parameters, perceived prostate function (IPSS), perceived erectile function (IIEF-5) and complications. RESULTS: Seven hundred thirteen patients underwent GL, and 234 patients underwent TURP. Overall, patients treated with GL show higher BMI, IIEF and medication use, together with lower urinary function (voided volume, incontinence, urinary retention) at baseline. After the procedure, despite higher antibiotic and antimuscarinic use and shorter hospital stay, readmission rates, PVR, PSA were higher, but Qmax, and IIEF were lower in the GL group. The rate of post-operative complications was 10.3% and 5.2% for the TURP and GL group, respectively (P=0.006). CONCLUSIONS: We were unable to categorically state which procedure is superior. This observational study confirms that treatment decision for either TURP or GL is not based on patient characteristics.

The effect of dutasteride on the efficacy of photoselective vaporization of the prostate: results of a randomized, placebo-controlled, double-blind study (DOP trial).

OBJECTIVES: To study the effect of Dutasteride on the efficacy of GreenLight photoselective vaporization of the prostate (PV). Some investigators have suggested that 5 alpha-reductase inhibitors may interfere with PV by reducing intraprostatic blood flow. Dutasteride offers the most complete blockade of the 5 alpha-reductase inhibitors, with minimal increase in side effects. METHODS: This is a prospective, placebo-controlled, randomized, double-blind study. A total of 59 patients were randomized to either dutasteride 0.5 mg or placebo for 3 months before and 12 months after PV. Surgical time, joules used, estimated blood loss, and ease of the procedure were compared. Other clinical end points investigated include postsurgical catheter time, hematuria, dysuria, urinary flow parameters, American Urological Association symptom score, benign prostatic hyperplasia quality of life score, prostate volume, and prostate-specific antigen level. RESULTS: Average surgical time and joules used were 12% (P = .24) and 16% (P = .15) less, respectively, for dutasteride patients compared with placebo. Estimated blood loss was also lower in the treatment group (P = .14). However, these results were not statistically significant. Surgeon-rated ease of the procedure was comparable between the 2 groups. There were no significant differences in catheter time, dysuria, quality of life scores, or urinary flow parameters. Quality of life and urinary parameters markedly improved after PV. CONCLUSIONS: Compared with patients randomized to placebo, patients randomized to dutasteride experienced a trend toward decreased time, joules used, and blood loss during surgery. Although we could not convincingly prove an operative benefit of treatment with dutasteride before surgery, we have demonstrated the efficacy of PV in men receiving dutasteride.

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.