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    Other relevant studies

    Other potentially relevant studies to the IP overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5 below.

    Case reports have been excluded.

    Table 5 additional studies identified

    Article

    Number of patients and follow up

    Direction of conclusions

    Reason study was not included in main evidence summary

    Assad A, Nguyen DD, Barber N et al. (2022) WATER vs WATER II 3-year update: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 cc and 80-150 cc prostates. Urology 165: 268–74

    Pooled analysis of 2 trials (WATER and WATER II)

    n=282 (217 water-jet ablation)

    Follow up: 36 months

    Three-year follow up demonstrates that Aquablation therapy leads to sustained outcomes, few irreversible complications, and low retreatment rates for the treatment of LUTS/BPH independently of prostate volume.

    Data from the 2 trials is already included in the key evidence.

    Bach T, Barber N, Elterman D et al. (2022) Aquablation outcomes in men with LUTS due to BPH following single versus multi-pass treatments. Urology 169: 167−172

    Pooled analysis of 2 trials (WATER and WATER II)

    n=282 (217 water-jet ablation)

    Follow up: 36 months

    A second pass of the waterjet had benefits in functional outcomes, as measured by IPSS, IPSS QoL, and Qmax in short-and intermediate-term follow up over a period of 36 months, even though the prostate volume was larger in these groups of patients. A second pass was associated with lower 24- and 36-month IPSS and IPSS QoL and a higher Qmax.

    There was no increased risk of complications associated with a second pass.

    Study focuses on the effect of multiple passes of the waterjet. Data from the 2 trials is already included in the key evidence.

    Bach T, Gilling P, Hajj A et al. (2020) First multi-center all-comers study for the aquablation procedure. Journal of Clinical Medicine 9: 603

    Prospective single-arm trial (OPEN WATER)

    n=178

    Follow up: 1 year

    Real-world evidence shows that the Aquablation procedure is a safe and effective treatment for symptomatic benign prostatic hyperplasia.

    Study is included in meta-analysis by Elterman et al. (2021).

    Bach T, Giannakis I, Bachmann A et al. (2019) Aquablation of the prostate: single-center results of a non-selected, consecutive patient cohort. World Journal of Urology 37: 1369–75

    Prospective cohort study

    n=118

    Follow up: 3 months

    There was significant and immediate improvement of functional voiding parameters Qmax and PVR as well as symptomatic improvement of IPSS and QoL. Aquablation seems to be safe and effective with a low perioperative complication profile even in a non-selected group of patients.

    Studies with more patients or longer follow up are included.

    Bhat A, Blachman-Braun R, Shah HN et al. (2021) Are all procedures for benign prostatic hyperplasia created equal? A systematic review on post-procedural PSA dynamics and its correlation with relief of bladder outlet obstruction. World Journal of Urology; 2021

    Systematic review

    Various surgical procedures for BPH result in varying PSA nadirs level. Enucleation procedures and simple prostatectomy produce the most drastic and sustained decrease in PSA. There is possible indirect evidence suggesting that the level of PSA nadir corresponds closely with the degree of post-operative improvement and durability of the procedure.

    Review focuses on PSA levels.

    Bhojani N, Yafi FA, Misrai V et al. (2021) Review of sexual preservation after novel benign prostatic hyperplasia surgical treatment modalities from Food and Drug Administration clinical trials. Sexual Medicine Reviews 9: 169–73

    Review of randomised controlled trials

    n=457 (116 water-jet ablation)

    Follow up: 3 years

    For prostates less than 80 mm, Aquablation and prostatic urethral lift showed permanent sexual function preservation in both Male Sexual Health Questionnaire Ejaculatory Function domain short form (ejaculatory function) and IIEF-5 (erectile function) at 3 years after treatment.

    Water-jet ablation data was taken from the WATER trial, which is already included in the key evidence.

    Bhojani N, Nguyen DD, Kaufman RP Jr et al. (2019) Comparison of <100 cc prostates and >100 cc prostates undergoing aquablation for benign prostatic hyperplasia. World Journal of Urology 37: 1361–68

    Prospective single-arm trial (WATER II)

    n=101

    Follow up: 3 months

    Aquablation clinically normalised outcomes in both prostate cohorts. It is safe and effective in patients with large prostate glands (more than 100 ml) with a smoother learning curve.

    Subgroup analysis of WATER II trial, comparing outcomes by prostate size.

    Bhojani N, Bidair M, Zorn KC et al. (2019) Aquablation for benign prostatic hyperplasia in large prostates (80 to 150 ml): 1-Year Results. Urology 129: 1–7

    Prospective single-arm trial (WATER II)

    n=101

    Follow up: 12 months

    The Aquablation procedure is demonstrated to be safe and effective in treating men with large prostates (80 to 150 ml) after 1 year of follow up, with an acceptable complication rate and without a significant increase in procedure or resection time compared to smaller sized glands.

    A report with longer term outcomes from the same study is included.

    Cantiello F, Fimognari D, Damiano R et al. (2021) Mechanical and ablative minimally invasive techniques for male LUTS due to benign prostatic obstruction: a systematic review according to BPH-6 evaluation. Urologia Internationalis 105: 858–68

    Systematic review

    48 studies in total (18 on transurethral water-jet ablation)

    The procedure shows functional results comparable with the gold standard represented by TURP at follow up of 2 years, but with the main advantage of lower adverse events and anejaculation rates. Compared to TURP, it is characterised by a minimal learning curve related to its operator-free execution.

    No meta-analysis.

    The relevant studies cited in the review are included in the main evidence or in the additional studies table.

    Chughtai B, Thomas D (2018) Pooled Aquablation results for American men with lower urinary tract symptoms due to benign prostatic hyperplasia in large prostates (60-150 cc). Advances in Therapy 35: 832–38

    Pooled analysis of 2 trials (WATER and WATER II)

    n=107

    Follow up: 3 months

    Men with LUTS secondary to BPH (60 to 150 ml) in a pooled analysis were treated safely and effectively with Aquablation up to 3 months postoperatively.

    Reports of longer term outcomes from the same studies are included.

    Colicchia M, Corsi P, Romagnoli D et al. (2021) The combination of waterjet ablation (Aquabeam) and holmium laser power for treatment of symptomatic benign prostatic hyperplasia: Early functional results. Central European Journal of Urology 74: 222–28

    Retrospective cohort study

    n=53

    Follow up: 3 months

    The combination of Aquabeam and holmium laser energy for haemostasis is a safe, reproducible technique to treat moderate LUTS in men with BPH while preserving ejaculation in younger and sexually active individuals. The short-term results showed a lower rate of complications and the encouraging functional results attest that this can be a valid surgical approach for the treatment of BPH.

    Small study assessing the combination of water-jet ablation and holmium laser energy for haemostasis.

    Dahm P, MacDonald R, McKenzie L et al. (2021) Newer minimally invasive treatment modalities to treat lower urinary tract symptoms attributed to benign prostatic hyperplasia. European Urology Open Science 26: 72–82

    Review

    12 studies (7 trials)

    The current best evidence underlying these newer therapies is limited to few trials (PUL and PAE), short-term follow up of 12 months (Aquablation and

    Rezum), or sham comparison only (Rezum).

    Only 1 study on water-jet ablation was included (Gilling et al., 2019).

    Das AK, Han TM, Uhr A et al. (2020) Benign prostatic hyperplasia: an update on minimally invasive therapy including Aquablation. The Canadian Journal of Urology 27: 2–10

    Review

    Aquablation, Rezum and Urolift are minimally invasive surgical treatment options capable of providing rapid, significant, and durable relief of LUTS secondary to BPH. Each technique demonstrates comparable efficacy to TURP with the added advantages of preserving sexual function, decreasing patient morbidity, and limiting healthcare costs.

    No meta-analysis.

    Desai M, Bidair M, Bhojani N et al. (2020) Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results. The Canadian Journal of Urology 27: 10147-10153

    Prospective single-arm trial (WATER II)

    n=101

    Follow up: 2 years

    Two-year prospective multicentre follow up demonstrated that the Aquablation procedure is safe and effective in the treatment of men with LUTS caused by BPH and prostates 80 to 150 ml with durable treatment efficacy, acceptable safety profile and a low retreatment rate.

    A report with longer term outcomes from the same study is included.

    Desai M, Bidair M, Zorn KC et al. (2019) Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial. BJU international 124: 321–28

    Prospective single-arm trial (WATER II)

    n=101

    Follow up: 6 months

    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 needing intervention or transfusion were recorded in 8 patients before discharge and in 6 patients after discharge. The mean IPSS improved from 23.2 at baseline to 6.7 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/second (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, PSA reduced from 7.1 ng/ml at baseline to 4.0 ng/ml, a 44% reduction.

    A report with longer term outcomes from the same study is included.

    Desai M, Bidair M, Bhojani N et al. (2019) WATER II (80-150 mL) procedural outcomes. BJU International 123: 106–112

    Prospective single-arm trial (WATER II)

    n=101

    Follow up: 1 month

    No patient needed electrocautery for haemostasis at the time of the primary procedure. The Clavien-Dindo grade 2 or higher event rate at 1 month was 30%. Bleeding complications were recorded in 10 patients (10%) during the index procedure hospitalisation before discharge and included 6 (6%) perioperative transfusions.

    A report with longer term outcomes from the same study is included.

    Desai MM, Singh A, Abhishek S et al. (2018) Aquablation therapy for symptomatic benign prostatic hyperplasia: a single-centre experience in 47 patients. BJU International 121: 945–51

    Case series

    n=47

    Follow up: 3 months

    The mean IPSS decreased from 24.4 at baseline to 5 at 3 months; IPSS QoL score decreased from 4.5 to 0.3 points; peak urinary flow rate increased from 7.1 to 16.5 ml/second and post-void residual urine volume decreased from 119 to 43 ml (all p<0.01).

    Studies with more patients or longer follow up are included.

    Dhliwayo B, Mukhtar S (2019) Novel surgical treatments for benign prostatic enlargement. Journal of Endoluminal Endourology 2: e18-e23

    Review

    The studies reviewed have all confirmed proof of sustained and effective relief of male LUTS symptoms. Aquablation (AQUABEAM System) has good comparable results to TURP, and further evaluation and studies are awaited to evaluate its efficacy.

    No meta-analysis.

    El Hajj A, Misrai V, Nasrallah AA et al. (2022) Learning curve in aquablation: an international multicenter study. World Journal of Urology 40: 773–79

    Case series

    n=175

    Follow up: 3 months

    Aquablation is associated with a quick learning curve for the defined outcomes. It provided effective LUTS relief and low complication rates independent of surgeon experience. Haemoglobin drop and ejaculatory function preservation were the 2 factors influenced by the surgeons' learning curve.

    Studies with more patients or longer follow up are included.

    EUnetHTA OTCA27 Authoring Team. Comparative effectiveness of surgical techniques and devices

    for the treatment of benign prostatic hyperplasia. Collaborative Assessment. Diemen (The Netherlands): EUnetHTA; 2021. Report No.: OTCA27. Available from: https //www.eunethta.eu.

    Systematic review

    84 randomised controlled trials (1 on water-jet ablation)

    Minimally invasive technologies are expected to reduce the short- and long-term side effects of standard surgical treatments for BPH (in particular in comparison to TURP) while preserving the effectiveness for functional outcomes.

    The review only includes 1 randomised controlled trial on water-jet ablation, which is already described in the key evidence.

    Fiori C, Checcucci E, Gilling P et al. (2020) All you need to know about "Aquablation" procedure for treatment of benign prostatic obstruction. Minerva urologica e nefrologica = The Italian Journal of Urology and Nephrology 72: 152–61

    Systematic review

    1 randomised controlled trial (WATER)

    n=184 (117 water-jet ablation)

    The results of this systematic review, based on a single RCT that compared Aquablation with TURP in prostates 30-80 ml in size, confirmed that Aquablation has at least a similar efficacy as TURP, but has a better safety profile, allows shorter resection times, and has a lower risk of

    retrograde ejaculation.

    Moreover, in some subcategories of patients (for example, when prostate volume is more than 50 ml) functional outcomes of Aquablation are better than those of TURP.

    The review only includes 1 randomised controlled trial, which is already described in the key evidence.

    Ghiraldi E, Higgins AM, Sterious S (2022) Initial experience performing "Cautery-Free Waterjet Ablation of the Prostate". Journal of Endourology 36: 1237–42

    Case series

    n=32

    Follow up: 30 days

    Performing waterjet ablation of the prostate without the use of electrocautery after waterjet treatment to control bleeding resulted in significant bleeding complications (25% of our cohort) during our initial experience. A combination of traction and focal bladder neck electrocautery is the best strategy to minimise bleeding complications after Aquablation.

    Studies with more patients or longer follow up are included.

    Gilling P, Barber N, Bidair M et al. (2019) Two-year outcomes after Aquablation compared to TURP: efficacy and ejaculatory improvements sustained. Advances in Therapy 36: 1326–36

    Randomised controlled trial (WATER)

    n=181

    Follow up: 2 years

    Two-year efficacy outcomes after TURP and Aquablation were similar, and the rate of surgical retreatment was low and similar to TURP.

    A more recent report with longer term outcomes is included.

    Gilling PJ, Barber N, Bidair M et al. (2019) Randomized controlled trial of Aquablation versus transurethral resection of the prostate in benign prostatic hyperplasia: one-year outcomes. Urology 125: 169–73

    Randomised controlled trial (WATER)

    n=181

    Follow up: 1 year

    The 1-year outcomes after TURP and Aquablation were similar and the rate of late procedure-related complications was low.

    A more recent report with longer term outcomes is included.

    Gilling P, Barber N, Bidair M et al. (2018) WATER: A double-blind, randomized, controlled trial of Aquablation R vs transurethral resection of the prostate in benign prostatic hyperplasia.

    The Journal of Urology 199: 1252–61

    Randomised controlled trial (WATER)

    n=181

    Follow up: 6 months

    Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit.

    A more recent report with longer term outcomes is included.

    Gilling P, Anderson P, Tan A (2017) Aquablation of the prostate for symptomatic benign prostatic hyperplasia: 1-year results. The Journal of Urology 197: 1565–72

    Prospective single-arm trial

    n=21

    Follow up: 1 year

    Mean IPSS score improved from 23.0 at baseline to 6.8 at 12 months (p<0.0001) and Qmax increased from 8.7 to 18.3 ml per second (p<0.0001). There wereno importantperioperative adverse events. No urinary incontinence developed and sexual function was preserved postoperatively.

    Studies with more patients or longer follow up are included.

    Gilling P, Reuther R, Kahokehr A et al. (2016) Aquablation – image-guided robot-assisted waterjet ablation of the prostate: initial clinical experience. BJU International 117: 923–29

    Prospective single-arm trial

    n=15

    Follow up: 6 months

    These preliminary results from this initial study show aquablation of the prostate is technically feasible with a safety profile comparable to other BPH technologies.

    Studies with more patients or longer follow up are included.

    Gross AJ, Becker B, Vogt K et al. (2021) Rectal perforation after aquablation of the prostate: lessons learned the hard way. World Journal of Urology 39: 3441–46

    Case reports

    n=2

    Rectal perforation

    These 2 cases of a rectal perforation after aquablation of the prostate demonstrate an unusual complication and its complex management. Diagnostic delay complicates its treatment. Therefore, immediate rectoscopy should be done routinely after the procedure.

    Case reports of a safety outcome that is already described in the key evidence.

    Hwang EC, Jung JH, Borofsky M et al. (2019) Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. The Cochrane Database of Systematic Reviews 2: cd013143

    Systematic review

    n=184

    (1 study)

    Follow up: 12 months

    Based on short-term (up to 12 months) follow up, the effect of Aquablation on urological symptoms is probably similar to that of TURP (moderate-certainty evidence). The effect on quality of life may also be similar (low-certainty evidence). Longer-term data and comparisons with other modalities appear critical to a more thorough assessment of the role of Aquablation for the treatment of LUTS in men with BPH.

    Review only includes 1 study, which is already described in the key evidence.

    Kasivisvanathan V, Hussain M (2018) Aquablation versus transurethral resection of the prostate: 1 year United States - cohort outcomes. The Canadian Journal of Urology 25: 9317–22

    Randomised controlled trial (WATER)

    n=90

    Follow up: 1 year

    Surgical prostate resection using Aquablation showed improvement in lower urinary tract symptoms at 1 year comparable to TURP, but with a lower risk of adverse events and ejaculatory dysfunction.

    The study presents data from the US cohort of the WATER study. Data from the whole study population is already included.

    Kasraeian A, Alcantara M, Alcantara KM et al. (2020) Aquablation for BPH. The Canadian Journal of Urology 27: 10378–81

    Case series

    n=55

    In the setting of a community private urology practice, Aquablation therapy was safe and effective for the treatment of men with BPH regardless of prostate shape or prostate size.

    Studies with more patients or longer follow up are included.

    Kim J, Polchert M, Chacko B et al. (2021) Do Minimally invasive benign prostatic hyperplasia treatments preserve sexual function? A contemporary review of the literature. Current Urology Reports 22: 56

    Review

    Rezum and Aquablation demonstrated preservation of overall ejaculatory function and erectile function at 36-month follow up. Similar outcomes occurred with UroLift after a 60-month follow up. Erectile function was preserved following prostate artery embolization and iTIND up to 12 months.

    No meta-analysis.

    Labban M, Mansour M, Abdallah N et al. (2021) Aquablation for benign prostatic obstruction: Single center technique evolution and experience. Investigative and Clinical Urology 62: 210–16

    Case series

    n=59

    Follow up: 3 months

    At 3 months, the average drop in serum prostate-specific antigen was 37% (p<0.0001) and functional outcomes were considerably improved. There were 14 adverse events in 13 patients (overall rate of 22%), with grade 1 and grade 2 complications comprising 71% of all adverse events.

    Studies with more patients or longer follow up are included.

    Misrai V, Rijo E, Zorn KC et al. (2019) Waterjet ablation therapy for treating benign prostatic obstruction in patients with small- to medium-size glands: 12-month results of the first French Aquablation clinical registry. European Urology 76: 667–75

    Case series

    n=30

    Follow up: 1 year

    The IPSS score improved to 3 at 6 months, with a mean change of 15.6 points (95% CI 13 to 18.2). IPSS improvements persisted at month 12. Qmax improved to 20.4 ml/second at 12 months. The 6-month rates of Clavien-Dindo grade 2 and 3 events were 13%. There were no reports of incontinence or de novo erectile dysfunction. Postoperative de novo ejaculatory dysfunction was observed in 27% of patients.

    Studies with more patients or longer follow up are included.

    Nguyen DD, Barber N, Bidair M et al. (2021) WATER versus WATER II 2-year update: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80-cm3 and 80-150-cm3 prostates. European Urology Open Science 25: 21–8

    Comparison of results from a randomised controlled trial (WATER) and single-arm trial (WATER II)

    n=218

    Follow up: 2 years

    Aquablation therapy clinically normalises outcomes among patients regardless of prostate size or shape. The advantages, namely short operative times and smooth learning curves for clinical outcomes, are comparable for both small-to-moderately-sized and large prostates. These findings suggest that the effectiveness of Aquablation is independent of prostate size and that outcomes are durable for up to 2 years of follow up.

    Data from the 2 trials is already included in the key evidence.

    Nguyen DD, Mantri SS, Zorn KC et al. (2021) Which anatomic structures should be preserved during Aquablation contour planning to optimize ejaculatory function? A case-control study using ultrasound video recordings to identify surgical predictors of postoperative anejaculation. Urology 153: 250–55

    Case-control study

    n=51

    Violation of anatomic structures involved in ejaculation during the Aquablation procedure increases the risk of postoperative anejaculation. More careful attention to these structures during contour planning may further improve ejaculatory function after Aquablation.

    Small study, focusing on technique.

    Nguyen DD, Barber N, Bidair M et al. (2020) Waterjet ablation therapy for endoscopic resection of prostate tissue trial (WATER) vs WATER II: comparing Aquablation therapy for benign prostatic hyperplasia in 30-80 and 80-150 mL prostates. BJU International 125: 112–22

    Comparison of results from a randomised controlled trial (WATER) and single-arm trial (WATER II)

    n=217

    Follow up: 12 months

    Water-jet ablation clinically normalises outcomes between patients with 30 to 80 ml prostates and patients with 80 to 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.

    Data from the 2 trials is already included in the key evidence.

    Nguyen DD, Misrai V, Bach T et al. (2020) Operative time comparison of aquablation, greenlight PVP, ThuLEP, GreenLEP, and HoLEP. World Journal of Urology 38: 3227–33

    Analysis of pooled data

    In this analysis of pooled data of multi-surgical techniques and technologies, aquablation provided the lowest operative time across all prostate volumes. Greenlight photovaporisation of the prostate had the longest procedure time for prostates larger than 40 ml.

    Pooled analysis, focusing on operative time across different techniques.

    Pimentel MA, Yassaie O, Gilling P (2019) Urodynamic outcomes after Aquablation.

    Urology 126: 165–70

    Randomised controlled trial (WATER)

    n=66

    Follow up: 6 months

    Improvements after Aquablation in objective measures of bladder outlet obstruction were similar to those observed after TURP.

    Subgroup analysis of WATER trial, focusing on urodynamic outcomes.

    Plante M, Gilling P, Barber N et al. (2019) Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial. BJU International 123: 651–60

    Randomised controlled trial (WATER)

    n=181

    Follow up: 6 months

    In men with moderate-to-severe lower urinary tract symptoms attributable to BPH and larger, more complex prostates, aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation.

    Subgroup analysis of WATER trial.

    Probst P, Desai M (2022) Expectations facing reality: complication management after Aquablation treatment for lower urinary tract symptoms. European Urology Focus 8: 1733–35

    Review

    The technique for cautery haemostasis after Aquablation

    is critical. Haemostasis is best achieved using a resectoscope with a hot thin loop to first remove the remnant ''fluffy'' ablated prostate tissue, revealing deeper bleeding vessels at the level of the capsule that need coagulation. This technique, followed by catheter balloon tension applied to the bladder neck and irrigation, has been adopted by nearly all Aquablation surgeons since 2020.

    Review of the management of bleeding complications.

    Raizenne BL, Bouhadana D, Zorn KC et al. (2022) Functional and surgical outcomes of Aquablation in elderly men. World Journal of Urology 40: 2515–20

    Pooled analysis of 2 trials (WATER and WATER II)

    n=217

    Follow up: 3 years

    Elderly men (age 65 and over) showed similar reductions in total IPSS (7.68 points versus 7.12 points) and similar increases in Qmax (20.6 ml/second versus 19.3 ml/second) compared to younger men. The ejaculatory dysfunction rate was similar for both cohorts (12% versus 10%). Elderly men experienced similar annual retreatment rates compared to young men (2% versus 1%).

    Data from the 2 trials is already included in the key evidence.

    Reale G, Cimino S, Bruno G et al. (2019) "Aquabeam R System" for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique. International Journal of Impotence Research 31: 392–99

    Systematic review

    9 studies

    n=664

    The Aquabeam System for the treatment of LUTS/BPH has proven to be a safe technique that provides functional outcomes comparable to TURP. About sexual outcomes, the most important data is the low rate of retrograde ejaculation. However, other multicentre randomised trials with larger cohorts and longer follow up are still needed.

    No meta-analysis.

    The studies cited in the review are included in the main evidence or in the additional studies table.

    Roehrborn CG, Teplitsky S, Das AK (2019) Aquablation of the prostate: a review and update. The Canadian Journal of Urology 26: 20–24

    Review

    Aquablation is a safe and effective option for treating LUTS secondary to BPH. Aquablation is a new surgical option that shows very promising short term results, in particular, due to its short resection time regardless of gland size and low rate of sexual side effects. This technology still requires further investigation to confirm durability and efficacy over time.

    No meta-analysis.

    Sadri I, Arezki A, Couture F et al. (2021) Reasons to overthrow TURP: bring on Aquablation. World Journal of Urology 39: 2291–99

    Review

    For small-medium prostates (30 to 80 ml), Aquablation's main advantages include better ejaculatory function and similar functional outcomes compared to TURP. For large prostates (80 to 150 ml), Aquablation demonstrates shorter operative time and superior ejaculatory function when compared to simple prostatectomy, HoLEP, and Greenlight photovaporisation of the prostate.

    No meta-analysis.

    Sajan A, Mehta T, Desai P et al. (2021) Minimally invasive treatments for benign prostatic hyperplasia: systematic review and network meta-analysis. Journal of Vascular and Interventional Radiology 33: 359–367

    Systematic review

    9 studies

    n=1,032 (117 water-jet ablation)

    The functional outcomes for Rezum, Urolift, Aquablation, and PAE demonstrated similar outcomes in urinary function. Although significant differences in outcomes were limited, Aquablation and PAE were the most durable at 12 months. The benefits of Aquablation are overshadowed by bleeding complications and the relatively high transfusion rates.

    Only 1 RCT was included on transurethral water-jet ablation (Gilling et al., 2018)

    Suarez-Ibarrola R, Bach T, Hein S et al. (2020) Efficacy and safety of aquablation of the prostate for patients with symptomatic benign prostatic enlargement: a systematic review. World Journal of Urology 38: 1147–63

    Systematic review

    16 studies

    n=446

    Data from prospective studies demonstrate that aquablation significantly improves symptom scores and bladder outlet obstruction. Moreover, the WATER study reports comparable outcomes to TURP at 2-year follow up with fewer adverse events and significantly lower anejaculation rates favouring aquablation. A longer follow up of enrolled patients is needed to confirm safety and to assess the efficacy of this procedure compared with other well-established treatment options.

    No meta-analysis.

    The relevant studies cited in the review are included in the main evidence or in the additional studies table.

    Tanneru K, Jazayeri S, Behzad A, Muhammad U et al. (2021) An indirect comparison of newer minimally invasive treatments for benign prostatic hyperplasia: a network meta-analysis model. Journal of Endourology 35: 409–16

    Network meta-analysis

    4 studies

    Patients who had Aquablation had greater improvement in IPSS, QoL, Qmax, and PVR compared to patients who had Rezum and UroLift. Patients in the Aquablation group had similar outcomes to patients who had TURP in all domains.

    Patients in the UroLift group performed better in the sexual function domain compared to patients in the TURP group, but not to patients in the Aquablation group.

    Only 1 RCT was included on transurethral water-jet ablation (Gilling et al., 2018)

    Tokarski AT, Leong JY, Roehrborn CG et al. (2021) Aquablation of the prostate: a review and update. The Canadian Journal of Urology 28: 17–21

    Review

    At up to 3 years of follow up, Aquablation performs favourably when compared to TURP in terms of alleviation of LUTS and preservation of sexual function compared to TURP. Safety profile was similar between Aquablation and TURP.

    No meta-analysis.

    Whiting D, Ng KL, Barber N (2021) Initial single centre experience of Aquablation of the prostate using the AquaBeam system with athermal haemostasis for the treatment of benign prostatic hyperplasia: 1-year outcomes. World Journal of Urology 39: 3019–24

    Case series

    n=55

    Follow up: 1 year

    The results from a single centre suggest Aquablation using an entirely athermal approach is a safe cavitating procedure resulting in significant LUTS improvement comparable to standard cavitating procedures with greater preservation of sexual function.

    Data was collected as part of the OPEN WATER trial, which is included in the meta-analysis by Elterman et al. (2021).

    Yafi FA, Tallman CT, Seard ML et al. (2018) Aquablation outcomes for the U.S. cohort of men with LUTS due to BPH in large prostates (80-150 cc). International Journal of Impotence Research 30 209–14

    Prospective single-arm trial

    n=82

    Follow up: 3 months

    Aquablation is a safe and effective treatment option for men with large prostates (80 to 150 ml) who have LUTS associated with BPH.

    Studies with more patients or longer follow up are included.

    Yee CH, Tang SF, Yuen SKK et al. (2022) Technique, outcome and changes in prostate dimensions in patients with urinary retention managed by aquablation. International Urology and Nephrology 54: 1787–92

    Prospective cohort study

    n=20

    Follow up: 6 months

    Aquablation provided a consistent improvement in symptoms, uroflowmetry and urodynamic parameters in patients with a urethral catheter. The complication profile from the current series showed that while Aquablation is not necessarily a better procedure than TURP, it is a feasible alternative when the equipment is available.

    Studies with more patients or longer follow up are included.

    Zorn KC, Bhojani N, Goldenberg SL et al. (2019) Aquablation among novice users in Canada: A WATER II subpopulation analysis. Canadian Urological Association Journal 13: e113-e118

    Prospective single-arm trial (WATER II)

    n=19

    Follow up: 3 months

    In this short-term, 3‑month analysis of Canadian men, Aquablation appears to provide a strong surgical alternative in patients with LUTS/BPH due to larger prostate volumes, with impressive functional outcomes, relatively short operative time and length of hospital stay, and acceptable complication and low transfusion rates.

    The study presents data from the Canadian cohort of the WATER II study. Data from the whole study population is already included.