Aquablation for benign prostatic hyperplasia: real‐world prostate size relevance and bleeding events across 6 years

Abstract

Objective

To present large‐scale safety outcomes, with a particular focus on postoperative bleeding following Aquablation for benign prostatic hyperplasia.

Patients and Methods

Patients who underwent Aquablation between 2019 and 2024 across Asia, Europe, and North America were assessed to evaluate trends in treated prostate sizes, which were visualised using density plots. A corporate prospective database was maintained, incorporating case recordings and data collected by on‐site company representatives. In addition, the incidence of postoperative bleeding—defined as transfusion or surgical takeback for haemostatic fulguration—was analysed using data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database and procedure counts by the manufacturer.

Results

A total of 70 270 Aquablation procedures were evaluated over the period from 2019 to 2024. The mean (standard deviation) prostate volume was 87.3 (42.4) mL, with a maximum recorded size of 1189 mL. Density plot analysis of prostate volumes demonstrated consistent utilisation of Aquablation across the full range of prostate sizes throughout all years studied. The overall rate of blood transfusion or return to the operating room for haemostatic fulguration was 0.2%, indicating a favourable safety profile across a very wide range of prostate sizes.

Conclusions

Aquablation has been consistently utilised across a broad spectrum of prostate sizes, with a low overall rate of transfusion or return to the operating room for bleeding control. These findings highlight the procedure's broad applicability and favourable safety profile in real‐world practice from 2019 to 2024.

Abbreviations

FBNC

focal bladder neck cautery

FDA

United States Food and Drug Administration

MAUDE

Manufacturer and User Facility Device Experience (database)

Introduction

Benign prostatic hyperplasia (BPH) is a progressive condition affecting >50% of men over the age of 50 years [1]. Clinically, it can lead to BOO, resulting in a range of LUTS. These symptoms, which can significantly impact quality of life, include weak urinary stream, urinary frequency, nocturia, incomplete emptying, and hesitancy [2]. Approximately 30% of patients will ultimately require surgical intervention due to worsening LUTS, complications from BPH, or failure/non‐compliance with medical therapy [3].

One of the latest advancements in surgical therapy for BPH is Aquablation, an ultrasound‐guided, robotically executed waterjet tissue resection technique [4]. Initially recommended for prostate sizes ranging from 30 to 80 mL, Aquablation has demonstrated efficacy in treating larger prostates, with clinical trial cases now extending up to 150 mL. This expansion in use has led to the refinement of techniques to optimise haemostasis [5, 6].

The rapid adoption of Aquablation is largely due to its advantages over traditional treatments, particularly its lower morbidity. It offers superior preservation of erectile function and antegrade ejaculation when compared to TURP [7]. Another key benefit is its significantly shorter operative time, outperforming various laser enucleation techniques and photovaporisation of the prostate [8]. Additionally, recent studies have shown promising same‐day discharge rates following the procedure [9, 10].

The safety of Aquablation in the postoperative period has been well established, with low complication rates [11]. Also, prospective international studies have consistently shown that Aquablation provides significant symptom relief and improves functional urinary outcomes, while maintaining a low incidence of irreversible complications [12, 13].

Although advancements in haemostasis have led to a reduction in blood transfusion rates, further research is needed to optimise bleeding control and enhance patient safety [14]. In this study, we aimed to conduct an in‐depth analysis of post‐Aquablation bleeding and assess its real‐world utilisation using global data.

Patients and Methods

Population and Database

A prospective database was maintained, incorporating data collected by on‐site company representatives and recordings of each procedure, which were further analysed using information from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database and manufacturer‐reported procedure counts. This data feeds into the standard post‐market surveillance protocols followed by the manufacturer of the Aquablation device.

These protocols track various procedural data points, including the date of the procedure, surgeon's name, prostate size, and any reported adverse events or complications. This meticulous data collection adhered to medical device regulations in the following countries: Austria, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Republic of Korea, Lebanon, New Zealand, Poland, Portugal, Spain, Switzerland, Taiwan (Republic of China), the UK, the USA, and the United Arab Emirates. It is crucial for the manufacturer's ongoing assessment and reporting of post‐market complaints and adverse events.

Aquablation and Haemostasis Technique

The Aquablation procedure was performed following the standard technique [3]. It employed real‐time ultrasound imaging, beginning with the generation of a three‐dimensional anatomical map of the prostate, to delineate the resection area and avoid critical structures. Subsequently, the waterjet ablation process is initiated, systematically resecting the targeted tissue. Upon completion of the ablation process, the AquaBeam handpiece is withdrawn, allowing for the insertion of a standard resectoscope sheath and monopolar or bipolar loop.

Focal bladder neck cautery (FBNC) is then performed, targeting deeper bleeding vessels that become accessible after the removal of the ‘fluffy’ residual tissue remnants left behind by the Aquablation procedure [4]. This non‐resective cautery, performed with either a monopolar or bipolar loop, ensures effective haemostasis at the bladder neck, thus minimising the risk of postoperative bleeding complications. FBNC was introduced as the standard global protocol in early 2020.

Outcomes

In order to analyse trends and potential risks associated with the Aquablation procedure, patients from Asia, Europe, and North America were assessed between 2019 and 2024. Their prostate sizes were evaluated across different periods and plotted in a density plot. Furthermore, the risk of bleeding, specifically defined as transfusion or takeback for fulguration, was evaluated using data from the FDA MAUDE database [15].

Results

Between 2019 and 2024, a total of 70 270 Aquablation procedures were performed across Asia, Europe, and North America. The mean (sd) prostate volume was 87.3 (42.4) mL, with a maximum recorded volume of 1189 mL. As illustrated in Fig. 1, the prostate size density plot demonstrates consistent utilisation of Aquablation across all prostate sizes, with no significant variation in distribution by year (2019–2024). North America had the highest proportion of large prostates, with 46.1% measuring >80 mL, whereas Europe and the Middle East reported the highest proportion of small prostates, with 1.6% measuring <30 mL, as summarised in Table 1.

Fig. 1.

Prostate size treated density plot by year.

Table 1.

Procedure characteristics by region (2019–2024).

Region	Prostate volume >80 mL, %	Prostate volume <30 mL, %
Asia	33.7	0.3
Europe/Middle East	35.5	1.6
North America	46.1	0.6
Total	45.0	0.7

Values are presented as percentages of treated patients within each region.

The prospective case‐detail database was merged with the FDA MAUDE database. The rate of transfusion decreased from 2.3% in 2019 to 0.1% by 2023 and 2024, resulting in an overall pooled incidence of 0.2%. Similarly, takeback for cautery declined from 2.7% in 2019 to 0.1% between 2022 and 2024, also yielding an overall pooled rate of 0.2%, as shown in Table 2 [15].

Table 2.

Annual rates of transfusion and takeback for cautery following Aquablation (2019–2024).

Complication	2019	2020	2021	2022	2023	2024	Overall rate
Transfusion, %	2.3	1.1	0.3	0.2	0.1	0.1	0.2
Takeback (cautery), %	2.7	1.6	0.3	0.1	0.1	0.1	0.2
Procedures, n	964	1590	4312	9384	20 304	33 716	70 270

Annual complication rates and corresponding number of Aquablation procedures performed between 2019 and 2024, including transfusion and takeback (cautery). Values are expressed as percentages for complications and as absolute counts for procedure volumes, with the overall rate representing the pooled incidence across all years.

When stratified by region, transfusion and takeback rates remained consistently low across all global markets. The overall transfusion rates were 0.2% in North America, Europe, Middle East, and Africa, and 0.1% in Asia. Similarly, overall takeback rates for cautery were 0.1% in North America, 0.5% in Europe, the Middle East, and Africa, and 0.2% in Asia.

Discussion

A multicentre study of 801 patients treated with Aquablation between 2014 and 2019, with a mean (sd) prostate volume of 67 (33) mL, reported a transfusion rate of 3.9% [16]. Likewise, the OPEN WATER (ClinicalTrials.gov identifier: NCT02974751) study, which included 178 men across five sites with a mean (sd) prostate size of 59.3 (26.9) mL, reported that 2.7% underwent transfusion within the first postoperative week, and 7.9% required re‐operation for post‐procedure bleeding [17]. However, the WATER II (ClinicalTrials.gov identifier: NCT03123250) trial, which included patients with substantially larger prostates (mean [sd] volume 107 [20] mL), demonstrated higher rates of bleeding‐related complications, with 9.9% experiencing events during the index hospitalisation and 5.9% requiring perioperative transfusion [13].

More recent evidence has demonstrated a decline in transfusion requirements. For instance, an ambulatory surgery centre study of 60 patients reported no transfusion events and achieved a 98% same‐day discharge rate [9], underscoring the progressive improvement in Aquablation's safety profile. In alignment with these findings, our global dataset spanning the past 6 years shows a substantial enhancement in perioperative haemostatic control, with transfusion rates decreasing from 2.3% in 2019 to just 0.1% in 2024.

When comparing Aquablation to other surgical treatments for BPH, published data show a transfusion rate of ~2% for TURP even though typically performed on prostate sizes of ≤80 mL, 0.5% for tissue vaporisation, and 2.4% for enucleation, according to data from the American College of Surgeons National Surgical Quality Improvement Program (ACS‐NSQIP; 2006–2011) [18]. Furthermore, the German Nationwide Inpatient Data (GRAND) study, which analysed 1 355 845 surgical BPH procedures, reported significantly lower odds of transfusion with Aquablation compared to TURP (odds ratio 0.60; 95% CI 0.47–0.76; P < 0.001) [19].

Another notable outcome from our study is the substantial reduction in takeback rates for haemostatic cautery, which declined from 2.7% in 2019 to just 0.1% in 2024. This trend is further supported by a recent meta‐analysis that included 32 studies comprising 10 randomised controlled trials and 22 prospective observational cohorts, with a total of 2400 participants. The median patient age was 66 years and the median prostate volume was 51.9 mL. Among all evaluated interventions, Aquablation demonstrated the lowest reintervention rate at 12 months, reported at only 0.01% [20]. The contemporary haemostasis methodology was refined through late 2019 and subsequently implemented and standardised across all global sites during 2020, which likely explains the marked reduction observed in 2021.

Historically, only a limited number of surgical technologies have been studied and routinely offered for the management of very large prostates. Among these, simple enucleation and simple prostatectomy—whether performed via open, laparoscopic, or robotic approaches—are invasive procedures associated with increased surgical risk and prolonged recovery [21]. However, over time there has been growing evidence in the literature supporting the use of Aquablation in patients with larger prostate volumes.

A comparative analysis involving men with prostate volumes >150 mL treated with Aquablation demonstrated comparable outcomes in symptom relief and functional metrics when evaluated alongside two other cohorts: men with prostates ≤80 mL from the WATER (ClinicalTrials.gov identifier: NCT02505919) study and those with 80–150 mL prostates from the WATER II study. Across these groups, there were no significant differences in improvements in IPSS, quality of life, or uroflowmetry parameters [22]. Recently, the WATER III (ClinicalTrials.gov identifier: NCT04801381) study, randomised trial comparing Aquablation vs laser enucleation in prostate sizes 80–180 mL, reported primary endpoint results at European Association of Urology (EAU) congress 2025 showing no difference of IPSS scores at 3 months. The study reported 0% transfusion for Aquablation and 2.3% for laser enucleation [23].

Regardless of prostate size or anatomy, Aquablation remains an effective treatment for BOO due to BPH [24, 25], demonstrating low postoperative transfusion rates and minimal recurrence over 5 years, as shown in a double‐blinded, multicentre, prospective randomised controlled trial involving 181 patients [26]. Our findings further support these outcomes, reinforcing the long‐term safety and of the procedure.

The limitations of our study are inherent to the MAUDE database itself. Adverse events are often underreported, and submitted reports may be incomplete, inaccurate, or lack standardisation. Follow‐up information is not consistently available, and many reports are missing key clinical details, limiting the depth of analysis. Furthermore, because reporting is passive and subject to variability in documentation, the risk of reporting and selection bias cannot be controlled.

Conclusion

This large‐scale, real‐world analysis of >70 000 Aquablation procedures performed between 2019 and 2024 demonstrates the widespread adoption of the technique across all prostate sizes, including very large glands, with a consistently favourable safety profile. The marked reduction in transfusion and surgical takeback rates over time highlights significant advancements in the safety and perioperative management of Aquablation.

Disclosure of Interests

Mario Bitar, Omar Buksh, Roseanne Ferreira and Sagi Shprits report no relevant conflicts of interest to disclose for this work. Dean Elterman, Kevin C. Zorn, Bilal Chughtai, Naeem Bhojani are consultants/investigators for Procept Biorobotics, Boston Scientific.