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Article of the week: WATER II (80–150 mL) procedural outcomes

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial written by a prominent member of the urological community. These are intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this week, it should be this one.

WATER II (80–150 mL) procedural outcomes

Mihir Desai*, Mo Bidair, Naeem Bhojani, Andrew Trainer§, Andrew Arther§Eugene Kramolowsky, Leo Doumanian*, Dean Elterman**, Ronald P. Kaufman Jr.††James Lingeman‡‡, Amy Krambeck‡‡, Gregg Eure§§, Gopal Badlani¶¶, Mark Plante***Edward Uchio†††, Greg Gin†††, Larry Goldenberg‡‡‡, Ryan Paterson‡‡‡, Alan So‡‡‡Mitch Humphreys§§§, Claus Roehrborn¶¶¶, Steven Kaplan****, Jay Motola**** and Kevin C. Zorn

 

*Institute of Urology, University of Southern California, Los Angeles, San Diego Clinical Trials, San Diego, CA, USA, University of Montreal Hospital Centre, University of Montreal, Montreal, QC, Canada, §Adult Paediatric Urology and Urogynecology, P.C., Omaha, NE, Virginia Urology, Richmond, VA, USA, **University Health Network University of Toronto, Toronto, ON, Canada, ††Albany Medical College, Albany, NY, ‡‡Indiana University Health Physicians, Indianapolis, IN, §§Urology of Virginia, Virginia Beach, VA, ¶¶Wake Forest School of Medicine,Winston-Salem, NC, ***University of Vermont Medical Centre, Burlington, VT, †††VA Long Beach Healthcare System, Long Beach, CA, USA, ‡‡‡University of British Columbia, Vancouver, BC, Canada, §§§Mayo Clinic Arizona, Scottsdale, AZ, ¶¶¶Department of Urology, UT Southwestern Medical Centre, University of Texas Southwestern, Dallas, TX and ****Icahn School of Medicine at Mount Sinai, New York, NY, USA

 

Abstract

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 large prostates (80–150 mL). The 6‐month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).

 

Editorial: Aquablating urological skills

Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue (WATER) II (80–150 mL) procedural outcomes by Desai et al. [1] in this issue of the BJUI, reports the results of a robotically controlled cavitating procedure in a multicentre prospective trial that may have wider implications than relief of prostatic hyperplasia causing obstruction.

Management of the large prostate (>80 mL) is often a challenge for many practicing Urologists and requires practice, constant development, and improvement in endoscopic skills. As a result, many differing approaches have been developed and honed, modifying and improving varied skills in the urologist’s armamentarium to equip them to tackle the large prostate. The traditional TURP is recommended only for prostates of 35–80 mL (European Association of Urology [EAU] guidelines 2015). Whilst there are some Urologists who have developed their TURP skills to tackle larger prostates [2], for most other urologists, other procedures have had to be developed to address the very large prostate (>80 mL). As the authors of the paper report, holmium laser enucleation of the prostate (HoLEP) and photoselective vaporisation of the prostate (PVP) have evolved to enable treatment of the larger prostates endoscopically, but have limited penetrance due to the relatively significant learning curve and fellowship training requirements. Open simple prostatectomy (OSP) has good results but significant potential complications [3]. Robot‐assisted simple prostatectomy is being evaluated as another option [4], but requires an expensive robot and extensive training to develop the skill‐set required to perform the procedure. Laparoscopic simple prostatectomy (LSP) also requires extensive training and experience.

The authors [1] report impressive results of aquablation in these usually challenging large prostates. The mean operative time (OT) was 37 min, which is quick for a large prostate. The average length of stay was 1.6 days. The transfusion rate (TR) was 5.9%, which is higher than HoLEP (0–4%) [4], but is lower than OSP, PVP and LSP. It is important to note that the study involved 16 different sites (13 American and three Canadian) and showed that similar results were achieved across all sites irrespective of the experience of the operator, highlighting the very low learning curve for this procedure. Although this was only a single‐arm study with no control group, the authors have endeavoured to provide a comparison of OT, mean hospital stay and TR between aquablation and other procedures (OSP, PVP, HoLEP and LSP; table 5) based on published literature. Complication rates, operative and hospital metrics of aquablation appear to compare favourably with the current accepted means of managing the large prostate.

The use of balloon tamponade for haemostasis appears to hark back to the days of hanging a saline bag attached to an Indwelling Catheter (IDC) off the end of the bed after a monopolar TURP. Bladder traction was maintained for an average of 18 h. The authors report that fulguration was available to the surgeons in this trial, but none chose to use it as they felt that balloon tamponade was an effective haemostatic mechanism. Fulguration was preferentially avoided based on the WATER trial [5], where it was noted that anejaculation rates were twice as large in the aquablation with fulguration compared to the aquablation without fulguration group (16% vs 7%). The company (PROCEPT BioRobotics, Redwood City, CA, USA) even developed a novel catheter tensioning device (CTD) to assist with controlling the tension on the balloon tamponade demonstrating the old adage that ‘Necessity is the mother of Invention’. It would be interesting to see an objective assessment of discomfort from the balloon tamponade in future studies.

The results of this safety and feasibility trial suggest that aquablation is a quick procedure (37 min) for managing very large prostates. The complication rate is comparable to current endoscopic techniques (HoLEP and PVP) and appears superior to more invasive techniques (LSP and OSP). This study only reported perioperative measures and safety outcomes. No functional outcome or effectiveness measures were reported. The initial WATER trial [5] hints at possible effectiveness, but we will have to wait to see the results from this particular cohort of patients with large prostates (WATER II).

The short learning curve hints at a possible future. If the functional results from this cohort of large prostates treated by the aquablation robot compare favourably to current techniques, the patient with the very large prostate will no longer be only treatable by a few surgeons with an advanced and particular skill set.

Is this truly a quick, safe, effective procedure with no learning curve for large prostates? A randomised controlled trial of longer duration to assess functional outcomes, durability and complications may determine if the aquablation robot eventually renders the current surgical skill sets redundant.

 

References

  1. Desai M, Bidair M, Bhojani N et al. Aquablation Procedural Outcomes for BPH in Large Prostates (80–150cc): Initial Experience. (WATER II {80‐150 ml} procedural outcomes). BJU Int 2019123: 106–12
  2. Persu C, Georgescu D, Arabagiu I, Cauni V, Moldoveanu C, Geavlete P. TURP for BPH. How large is too large? J Med Life 201015: 376–80
  3. Gratzke C, Schlenker B, Seitz M et al. Complications and early postoperative outcome after open prostatectomy in patients with benign prostatic enlargement: results of a prospective multicenter study. J Urol 2007177: 1419–22
  4. Pokorny M, Novara G, Geurts N et al. Robot‐assisted simple prostatectomy for treatment of lower urinary tract symptoms secondary to benign prostatic enlargement: surgical technique and outcomes in a high‐volume robotic centre. Eur Urol 201568: 451–7
  5. Gilling PJ, Barber NJ, Bidair M et al. WATER: a double‐blind, randomized, controlled trial of aquablation® vs transurethral resection of the prostate in benign prostatic enlargement. J Urol 20185: 1252–61

 

Article of the week: Large BPH responds well to bipolar plasma enucleation

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video of a bipolar plasma enucleation procedure from Dr Geavlete and colleagues.

If you only have time to read one article this week, it should be this one.

Bipolar plasma enucleation of the prostate vs open prostatectomy in large benign prostatic hyperplasia cases – a medium term, prospective, randomized comparison

Bogdan Geavlete, Florin Stanescu, Catalin Iacoboaie and Petrisor Geavlete

Department of Urology, ‘Saint John’ Emergency Clinical Hospital, Bucharest, Romania

OBJECTIVES

• To evaluate the viability of bipolar plasma enucleation of the prostate (BPEP) by comparison with open transvesical prostatectomy (OP) in cases of large prostates with regard to surgical efficacy and peri-operative morbidity.

• To compare the medium-term follow-up parameters specific for the two methods.

PATIENTS AND METHODS

• A total of 140 benign prostatic hyperplasia (BPH) patients with prostate volume >80 mL, maximum flow rate (Qmax) <10 mL/s and International Prostate Symptom Score (IPSS) >19 were randomized in the two study arms.

• All cases were assessed preoperatively and at 1, 3, 6 and 12 months after surgery by IPSS, Qmax, quality of life score (QoL) and post-voiding residual urinary volume (PVR).

• The prostate volume and prostate specific antigen (PSA) level were measured at 6 and 12 months.

RESULTS

• The BPEP and OP techniques emphasized similar mean operating durations (91.4 vs 87.5 min) and resected tissue weights (108.3 vs 115.4 g).

• The postoperative haematuria rate (2.9% vs 12.9%) as well as the mean haemoglobin drop (1.7 vs 3.1 g/dL), catheterization period (1.5 vs 5.8 days) and hospital stay (2.1 vs 6.9 days) were significantly improved for BPEP.

• Recatheterization for acute urinary retention was more frequent in the OP group (8.6% vs 1.4%), while the rates of early irritative symptoms were similar for BPEP and OP (11.4% vs 7.1%).

• During the follow-up period, no statistically significant difference was determined in terms of IPSS, Qmax, QoL, PVR, PSA level and postoperative prostate volume between the two series.

CONCLUSIONS

• BPEP represents a promising endoscopic approach in large BPH cases, characterized by good surgical efficiency and similar BPH tissue removal capabilities compared with standard transvesical prostatectomy.

• BPEP patients benefited from significantly reduced complications, shorter convalescence and satisfactory follow-up symptom scores and voiding parameters.

 

Read Previous Articles of the Week

 

Editorial: Bipolar plasma enucleation: a new gold standard for BPH?

The history of surgical enucleation for BPH dates back over 100 years and it continues to be the most complete and efficient method of removing adenomata of any size. The popularity and performance of the open approach has declined recently but new enucleation techniques have emerged. In this edition of the journal, Geavlete et al. have studied a recent addition to the endoscopic enucleation armamentarium, namely ‘plasma-button’ bipolar enucleation (BPEP). This procedure is a variation on bipolar endoscopic enucleation using a coiled electrode(or PkEEP) first described in 2006. These authors’ unique contribution to the literature is to compare electrosurgical endoscopic enucleation with open prostatectomy in large prostates (>80 g by TRUS) in a randomized trial and provide Level 1 evidence for this technique. The groups were well-matched preoperatively and were equivalent in terms of operating time, weight of tissue retrieved and postoperative variables up to 12-month follow-up. Significant advantages were noted in perioperative outcomes in favour of the endoscopic technique, particularly those outcomes related to blood loss and subsequent hospital stay. Although not specifically addressed, it is highly likely that substantial cost savings were also achieved and patients returned to normal activities sooner with the endoscopic approach.

Endoscopic enucleation for very large prostates using the Holmium laser as the energy source, was first described over a decade ago. Holmium laser enucleation of the prostate (HoLEP) has been compared with open prostatectomy in two randomized trials (Eur Urol 2006, Eur Urol 2008and similar advantages were noted to those of BPEP in the comparison. The next question is, therefore, which of the endoscopic enucleation techniques is superior? Before this question can be answered, we need to separate those techniques that merely resect large tissue fragments (a ‘mega-resection’), and call themselves ‘enucleation’, from those that truly involve complete enucleation of the anatomical lobes using established surgical planes. HoLEP clearly falls into the latter category but electrosurgical methods may or may not because the actual surgical plane, with both electrosurgery and continuous laser wavelengths such as the Thulium : YAG, 532 nm and Diode lasers, is more difficult to achieve and follow. Exponents of these alternative energy sources perform a variety of different procedures, ranging from resection and vaporization hybrids through to a true enucleation technique, all under the banner of ‘enucleation’. For example, green EP with a side-firing fibre, can be a true enucleation technique if blunt dissection is also employed or a ‘mega-resection’ if the laser energy is merely used to cut off the lobe as a single large fragment. The use of the morcellator is also variable, with some authors instead reverting to the resectoscope to resect the lobes while they remain attached at the bladder neck.

The movement back to enucleation techniques, which also yield tissue for analysis, is partly attributable to the desire to detect transition zone cancers but, more importantly, to address the inadequacy of other endoscopic procedures in treating the growing number of huge glands confronting the urologist as a long-term result of the rise of medical therapy. Traditionally, glands > 80–100 g have been thought to be unsuitable for TURP and morbidity becomes significant although laser techniques such as 532 nm vaporization with high-powered devices have been employed in large glands, albeit with prolonged operating times. Unsurprisingly, the retropubic and suprapubic techniques have also been re-visited by robotic surgeons but with more morbidity than HoLEP, although this will probably improve.

Endoscopic enucleation seems to be here to stay with mounting scientific and popular support. It remains to be seen which variation will gain ascendancy in the coming years, but commercial considerations rather than science will probably be the major determining factor.

Peter J. Gilling
Department of Urology, Tauranga Hospital, Tauranga, New Zealand

Video: Bipolar plasma enucleation vs open prostatectomy

Bipolar plasma enucleation of the prostate vs open prostatectomy in large benign prostatic hyperplasia cases – a medium term, prospective, randomized comparison

Bogdan Geavlete, Florin Stanescu, Catalin Iacoboaie and Petrisor Geavlete

Department of Urology, ‘Saint John’ Emergency Clinical Hospital, Bucharest, Romania

OBJECTIVES

• To evaluate the viability of bipolar plasma enucleation of the prostate (BPEP) by comparison with open transvesical prostatectomy (OP) in cases of large prostates with regard to surgical efficacy and peri-operative morbidity.

• To compare the medium-term follow-up parameters specific for the two methods.

PATIENTS AND METHODS

• A total of 140 benign prostatic hyperplasia (BPH) patients with prostate volume >80 mL, maximum flow rate (Qmax) <10 mL/s and International Prostate Symptom Score (IPSS) >19 were randomized in the two study arms.

• All cases were assessed preoperatively and at 1, 3, 6 and 12 months after surgery by IPSS, Qmax, quality of life score (QoL) and post-voiding residual urinary volume (PVR).

• The prostate volume and prostate specific antigen (PSA) level were measured at 6 and 12 months.

RESULTS

• The BPEP and OP techniques emphasized similar mean operating durations (91.4 vs 87.5 min) and resected tissue weights (108.3 vs 115.4 g).

• The postoperative haematuria rate (2.9% vs 12.9%) as well as the mean haemoglobin drop (1.7 vs 3.1 g/dL), catheterization period (1.5 vs 5.8 days) and hospital stay (2.1 vs 6.9 days) were significantly improved for BPEP.

• Recatheterization for acute urinary retention was more frequent in the OP group (8.6% vs 1.4%), while the rates of early irritative symptoms were similar for BPEP and OP (11.4% vs 7.1%).

• During the follow-up period, no statistically significant difference was determined in terms of IPSS, Qmax, QoL, PVR, PSA level and postoperative prostate volume between the two series.

CONCLUSIONS

• BPEP represents a promising endoscopic approach in large BPH cases, characterized by good surgical efficiency and similar BPH tissue removal capabilities compared with standard transvesical prostatectomy.

• BPEP patients benefited from significantly reduced complications, shorter convalescence and satisfactory follow-up symptom scores and voiding parameters.

 

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