4th Annual Jefferson Urology Symposium: Focus on Urinary Incontinence

© The Canadian Journal of Urology TM : International Supplement, August 2021 with regards to safety with 26% of the cohort meeting the safety endpoint, while 42% of patients undergoing TURP met these criteria. Importantly, all of the persistent Clavien-Dindo grade one events were due to retrograde ejaculation which was seen in 6.9% of Aquablation patients and 24.6% of TURP patients. To further assess ejaculatory function, MSHQ-EjD self- reported data was collected, showing that 90 days after the procedure, the Aquablation patients had a slight improvement overall in ejaculatory scores while the TURP group had a significant decrease in scores. A similar analysis was done to assess incontinence using the incontinence severity index, which is also self-reported. Results of this analysis showed significant improvement in the Aquablation group. The change in IPSS scores overtime was used to determine the efficacy endpoint. The Aquablation cohort had an average IPSS score of 6.0 at 6 months, compared to an average of 6.7 for the TURP group, demonstrating non-inferiority. Lastly, Qmax and PVR volumes were assessed at 30-day postoperative intervals up to 180 days. This analysis showed similar results for PVR in both groups with slightly improved Qmax at 180 days for the Aquablation group relative to those patients who had undergone TURP. After the WATER trial, the WATER II trial was conducted to assess the safety and feasibility of Aquablation in larger prostates, those measuring between 80-150 mL. 12 This was also a prospective multicenter study. In total 101 men were included in the final cohort. Despite larger prostate sizes, average operating time was 37 minutes with an average resection time of 8 minutes. Atotal of 66.3% of patients included required additional passes with the machine to complete the resection, but all were completed in a single setting. Again, composite endpoints were used for both safety and efficacy. At 3 months, safety was assessed using the same safety endpoints as described in the original WATER trial. For efficacy, the change in IPSS scores at 3 months from baseline was used. Both the safety and efficacy endpoints were then compared to an objective performance criterion (OPC) which allowed for assessment of non- inferiority. Operative reports showed that 82%of these procedures were done under spinal anesthesia. Safety endpoints at 3 months were met in 44.5% of patients well below the OPC of 65%. These results reached statistical significance, and the procedure was non- inferior when compared to the OPC. When assessing efficacy, Aquablation greatly exceeded the OPC set for the change in IPSS score, demonstrating non- inferiority. Additionally, prostate volume reduction was measured, showing a 44% reduction in size at 3 months post procedure. Hemostasis was achieved for the majority of patients using a Foley catheter placed in the bladder under traction overnight using a device from PROCEPT BioRobotics. Three patients did require a catheter balloon being inflated in the prostatic fossa. The average length of catheter duration was 94 hours with an average of 18 hours under tractionwhen this method of achieving hemostasis was used. There was an average hemoglobin drop of 2.9 g/dL when comparing baseline values to discharge lab values. Of the 101 patients, there are a total of 10 transfusions required between the completion of the operation and 1 month, with one patient requiring a return to the operating room. While there is no trial that directly compares newer minimally invasive surgical techniques for the management of BPH (Rezum, Urolift, and Aquablation), Tanneru et al performed a meta- analysis of the available data to compare the three techniques. 13 This study included outcome reports among patients with prostates up to 80 mL. Follow up data was available up to 24 months across all three interventions. At 1month,Aquablation showed higher improvement in IPSS scores compared to Rezum and Urolift. Aquablation and Rezum continued to showed improvement up to 6 months, whereas Urolift showed improvement up to 3 months with a steady decline thereafter. In terms of quality of life (QoL) scores, Aquablation and Urolift showed a greater improvement than Rezum. Aquablation continues to be superior to both at 6 months, a trend which persisted up to 24 months. Aquablation showed further improvement in Qmax at time intervals assessed, with an average improvement of 6.3 mL/s higher improvement compared to Rezum and Urolift. Improvement in PVR favored Aquablation out to 24 months. In terms of sexual function, Male Sexual Health Questionnaire – Ejaculatory Domain (MSHQ- EjD) scores showed a greater improvement in Urolift compared to Aquablation and Rezum at 6 and 12 months, though patients who underwentAquablation, showed continued improvement beyond this point, which was not seen after the other two interventions. Aquablation patients were more likely to experience postoperative urinary retention. At 2 years follow up, the retreatment rates for Aquablation, Rezum, and Urolift were 4.3%, 4%, and 7.5% respectfully. One concern overAquablationwould be the relative lack of control of postoperative bleeding, as the water jet does not have the same coagulative properties as monopolar and bipolar electrocautery and the various laser modalities used (holmium, thulium, and photovaporization) in the surgical treatment of 19 Aquablation of the prostate: a review and update

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