Citations

AbstractObjectiveThis study aims to compare the long‐term outcomes of Aquablation for small‐to‐moderate (30–80 cm3) prostates with the outcomes for large (80–150 cm3) prostates at 5‐year follow up.MethodsThe Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER; NCT02505919) is a prospective, double‐blind, international clinical trial encompassing 116 patients, examining Aquablation versus transurethral resection of the prostate (TURP) for LUTS/BPH in prostates sized between 30 and 80 cm3. In parallel, WATER II (W‐II; NCT03123250), a prospective, multicentre, single‐arm international clinical trial, explores Aquablation outcomes in prostates ranging from 80 to 150 cm3. Baseline parameters and 60‐month outcomes were scrutinized using statistical analyses, including Students' t test, Wilcoxon tests for continuous variables, and Fisher's test for binary variables.ResultsThere is a significant improvement in International Prostate Symptom Score (IPSS) from baseline to 60 months in both WATER (22.9 to 7.0) and WATER II (23.2 to 6.8) (P = 0.852). Urinary flow rate (Qmax) increased in both groups from baseline to 60 months (WATER: 9.4 to 17.3 cc/s; WATER II: 8.7 to 17.1 cc/s) (P = 0.933). Immediate and sustained enhancements were observed in IPSS and Qmax. At 5 years, a notable percentage of patients in both groups were BPH medication‐free (WATER: 99%; WATER II: 94%) (P = 0.0517) and free from surgical retreatment (WATER: 95%; WATER II: 97%) (P = 0.508).ConclusionsThe 5‐year follow‐up affirms that Aquablation therapy exhibits sustained outcomes, minimal irreversible complications, and low retreatment rates for treating LUTS/BPH, irrespective of prostate volume ranging from 30 to 150 cm3.

AbstractObjectiveThe objective of this study is to determine if Aquablation therapy can maintain its effectiveness in treating men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with large‐volume (80–150 cc) prostates at 3 years.Subjects and MethodsOne hundred one men with moderate‐to‐severe BPH symptoms and prostate volumes between 80 and 150 cc were enrolled in a prospective, nonrandomized, multicenter, international clinical trial in late 2017. Baseline, procedural, and follow‐up parameters were recorded at baseline and scheduled postoperative visits. IPSS, Qmax, and treatment failure are reported at 3 years.ResultsThe mean prostate volume was 107 cc (range 80–150). Mean IPSS improved from 23.2 at baseline to 6.5 at 3 years (16.3‐point improvement, p < 0.0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 3 years (improvement of 3.4 points, p < 0.0001). Maximum urinary flow increased from 8.7 to 18.5 cc/s. At 3 year follow‐up, 6% of treated patients needed BPH medication and an additional 3% required surgical retreatment for LUTS.ConclusionsThree‐year follow‐up demonstrates a sustained symptom reduction response along with low irreversible complications to Aquablation in men with LUTS due to BPH and prostates of 80–150 cc. Current treatment options available for men with prostates of this size have similar efficacy outcomes but are burdened with high rates of irreversible complications. There are now numerous clinical studies with Aquablation used in various prostates sizes, and it should be offered as an option to men with LUTS due to BPH.

AbstractBackgroundPeripheral nerve damage resulting in pain, loss of sensation, or motor function may necessitate a reconstruction with a bridging material. The RANGER® Registry was designed to evaluate outcomes following nerve repair with processed nerve allograft (Avance® Nerve Graft; Axogen; Alachua, FL). Here we report on the results from the largest peripheral nerve registry to‐date.MethodsThis multicenter IRB‐approved registry study collected data from patients repaired with processed nerve allograft (PNA). Sites followed their own standard of care for patient treatment and follow‐up. Data were assessed for meaningful recovery, defined as ≥S3/M3 to remain consistent with previously published results, and comparisons were made to reference literature.ResultsThe study included 385 subjects and 624 nerve repairs. Overall, 82% meaningful recovery (MR) was achieved across sensory, mixed, and motor nerve repairs up to gaps of 70 mm. No related adverse events were reported. There were no significant differences in MR across the nerve type, age, time‐to‐repair, and smoking status subgroups in the upper extremity (p > .05). Significant differences were noted by the mechanism of injury subgroups between complex injures (74%) as compared to lacerations (85%) or neuroma resections (94%) (p = .03) and by gap length between the <15 mm and 50–70 mm gap subgroups, 91 and 69% MR, respectively (p = .01). Results were comparable to historical literature for nerve autograft and exceed that of conduit.ConclusionsThese findings provide clinical evidence to support the continued use of PNA up to 70 mm in sensory, mixed and motor nerve repair throughout the body and across a broad patient population.

Objective To compare the outcomes of Aquablation in 30–80 mL prostates with those in 80–150 mL prostates. Surgical options, especially with short learning curves, are limited when treating large prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) could solve this issue with global reproducibility, independent of prostate volume. Patients and Methods Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue (WATER [W‐I]; NCT02505919) is a prospective, double‐blind, multicentre, international clinical trial comparing Aquablation and transurethral resection of the prostate (TURP) for the treatment of LUTS/BPH in prostates between 30 and 80 mL. WATER II (W‐II; NCT03123250) is a prospective, multicentre, single‐arm international clinical trial of Aquablation in prostates between 80 and 150 mL. We compare baseline parameters and 12‐month outcomes in 116 W‐I and 101 W‐II study patients. Students’ t ‐test or Wilcoxon tests were used for continuous variables and Fisher’s test for binary variables. Results The mean (SD) operative time was 33 (17) and 37 (13) min in W‐I and W‐II, respectively. Actual treatment time was 4 and 8 min in W‐I and W‐II, respectively. The mean change in the International Prostate Symptom Score was substantial averaging (at 12 months) 15.1 in W‐I and 17.1 in W‐II ( P = 0.605). By 3 months, Clavien–Dindo grade ≥II events occurred in 19.8% of W‐I patients and 34.7% of W‐II patients ( P = 0.468). Conclusion Aquablation clinically normalises outcomes between patients with 30–80 mL prostates and patients with 80–150 mL prostates treated for LUTS/BPH, with an expected increase in the risk of complications in larger prostates. Long‐term outcomes of procedure durability are needed.

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 LUTS attributable to BPH were 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.

Objectives To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large‐volume benign prostatic hyperplasia ( BPH ). Methods Between September and December 2017, 101 men with moderate‐to‐severe BPH symptoms and prostate volume of 80–150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra‐operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee. Results The mean (range) prostate volume was 107 (80–150) mL. The mean (range) operating time was 37 (15–97) min and aquablation resection time was 8 (3–15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction ( n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa ( n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien–Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri‐operative transfusions. Conclusions Aquablation is feasible and safe in treating men with men with large prostates (80–150 mL). The 6‐month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT 03123250).