Tag Archive for: Benign Prostatic Hyperplasia

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Editorial: Prostatic Artery Embolization: Adding to the arsenal against the hapless prostate.

Ever since Hugh Hampton Young introduced the cold punch method in 1909 for ‘punching out’ pieces of the prostate through a modified urethroscope, urologists have used a bewildering array of technology and methods to wage war against the hapless prostate. Methods in the current arsenal include ‘heat and kill’ (transurethral needle ablation, transurethral microwave therapy and Rezum treatment), ‘freeze and kill’ (cryotherapy), ‘slice’ (transurethral incision of prostate), ‘dice’ (transurethral resection of prostate [TURP]), ‘eviscerate and leave the prostate a shell of its former self’ (open prostatectomy and holmium laser enucleation of prostate), ‘suspend and open’ (Urolift), ‘poison’ (intraprostatic injections with Botox, alcohol and NX 1207), ‘vaporize’ (photoselective vaporization of the prostate [PVP]) and, if the prostate dares to turn cancerous, then we just cut it out with scalpels or robots. For the best Botox treatment baytown do follow us.  Prostatic artery embolization (PAE) adds to our already impressive armamentarium via a technique similar to strangulation by blocking arterial flow and essentially causing prostatic infarction. PAE also brings a member of another medical discipline to the frontline: the radiologist.

In this issue of BJUI, Müllhaupt et al. [1] report an in-hospital cost analysis of PAE compared to TURP, in their post hoc analysis of a randomized controlled trial. Treatment costs are an important component of healthcare but are a narrow and focused view of the overall management of BPH in an individual patient. The authors report that the in-hospital costs for PAE and TURP are similar and, therefore, cost should not be a consideration when deciding between PAE and TURP. Interestingly, the main procedural costs for TURP were anaesthesia, and the main cost factor for PAE was medical supplies. The urologist and radiologist physician charges were ~13% and ~15% of the procedural costs, respectively. So, if the costs of PAE and TURP are similar, how do you assess which to use?

The article by Müllhaupt et al. should be read in conjunction with other papers describing the efficacy, safety and outcomes of PAE compared to TURP, especially the original article by Abt et al. [2] from which this cost analysis is derived and the UK-ROPE study by Ray et al. [3].

Historically, prostatic infarction is known to be a possible result of cross-clamping the aorta for coronary or aortic surgery, hypotensive myocardial infarction or septic shock. PAE is an iatrogenic cause of prostatic infarction. In 1947, Wilbur G. Rogers [7], in ‘Infarct of the Prostate’, documented that ‘There is first swelling of the area involved, with degeneration and necrosis of the cells. This may be followed by absorption of the damaged area and fibrosis and cicatrization of the parts so that eventually the volume is much less than it was originally’. This is one of the early descriptions of how PAE potentially works.

Prostatic artery embolization as a technique is feasible and has been shown to be relatively safe and efficacious in certain specialized institutions, as shown by the UK-ROPE study [3] and by Abt et al. [2]. It should be noted that PAE can be a technically challenging procedure and, although bilateral embolization is the goal, only unilateral embolization is possible in 25% of cases [1]. Highly specialized training is required, and the technique continues to evolve to avoid embolization of extraprostatic branches [3]. PAE is more painful than TURP, with higher reported pain on a visual analogue scale and higher analgesic use [2], but is associated with a shorter length of hospital stay [1,2]. PAE is reported to be associated with an earlier return to normal activities but is less effective than TURP at 12 weeks with regard to changes in maximum rate of urinary flow, postvoid residual urine, prostate volume and desobstructive effectiveness according to pressure flow studies [2] and has a 20% reoperation rate after 12 months [3].

There are still some questions and issues surrounding PAE that may eventually be addressed with time and further studies. Embolizing an artery causes cell death and necrosis and eventual atrophy. This process is uncontrolled, however, and unpredictable in any individual patient. There is no way to know how much tissue or which part of the prostate is going to infarct and undergo necrosis with unilateral or bilateral embolization. If or when a potential abscess forms has not been defined or studied.

The longer-term effects of radiation dosage for PAE will not be known for many years. In the Abt et al. study cohort [2], the radiation dose (dose area product [DAP]) was 176.5 Gy/cm2. A standard anteroposterior and lateral chest X-ray exposes the patient to 0.3 Gy/cm2. An abdominal CT scan exposes the patient to ~32 Gy/cm2. PAE is thus roughly equivalent to ~5–10 standard abdominal/pelvic CT scans (more if using ultra-low dose scanners), 586 chest X-rays, 4.4 barium enemas or 8.8 voiding cysto-urethrograms. Markar et al. [4] reported that there was a significant increase in abdominal cancer within the radiation field in 14 150 patients undergoing endovascular aneurysm repair (EVAR), with 18% of patients who underwent EVAR succumbing to cancer. The mean radiation exposure (or DAP) in a review of 24 studies on EVAR [5] was 79.48 Gy/cm2, which is approximately half the radiation exposure of PAE.

Müllhaupt et al. [1] showed that PAE was associated with a quicker return to normal activities and a shorter length of stay than TURP, with similar in-hospital costs in Switzerland. Cost, however, must be considered alongside safety and efficacy data both in the short and long term. It is important to appreciate the specialized and technical expertise required to safely perform PAE and the importance of a urologist being part of the multidisciplinary management team as recommended in the National Institute for Health and Care Excellence (NICE) guidelines [6] (IPG611 April 2018). Radiation exposure will need close scrutiny and detailed reporting to document long-term effects, as demonstrated in the EVAR trials. Radiation dosage is cumulative over a lifetime and this must be considered when other interventional radiological procedures such as coronary angiograms and positron-emission tomography/CT are becoming more common. PAE should be compared with other emerging minimally invasive BPH procedures such as Urolift and Rezum in future studies, instead of just TURP to determine its role in BPH management and whether the radiation dose is justified. Longer-term studies are needed to assess the costs of managing any long-term
complications, re-operation rates and longer-term efficacy associated with PAE.

by Peter Chin
South Coast Urology, Wollongong, NSW, Australia

References

  1. Müllhaupt G, Hechelhammer L, Engeler D et al. In-Hospital cost analysis of prostatic artery embolization compared to transurethral resection of the prostate: post hoc analysis of a randomized controlled trial. BJU Int 2019;123: 1055-60
  2. Abt D, Hechelhammer L, Müllhaupt G et al. Comparison of prostatic artery embolization (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomized, open label, noninferiority trial. BMJ 2018; 361: k2338
  3. Ray AF, Powell J, Speakman MJ et al. Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study). BJU Int 2018; 122: 270–82
  4. Markar SR, Vidal-Diez A, Sounderajah V et al. A population-based cohort study examining the risk of abdominal cancer after endovascular abdominal aortic aneurysm repair. J Vasc Surg 2018; Article in Press. https://doi.org/10.1016/j.jvs.2018.09.058 [Epub ahead of print]
  5. Monastiriotis S, Comito M, Lapropoulos N. Radiation exposure in endovascular repair of abdominal and thoracic aortic aneurysms. J Vasc Surg 2015; 62: 753–61
  6. NICE Guidance. Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia. BJU Int 2018; 121: 825–34
  7. Rogers WG. Infarct of the prostate. J Urol 1947; 57: 484–7

 

Article of the week: Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial

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.

Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial

Mark Plante1, Peter Gilling2, Neil Barber3, Mohamed Bidair4, Paul Anderson5, Mark Sutton6, Tev Aho7, Eugene Kramolowsky8, Andrew Thomas9, Barrett Cowan10, Ronald P. Kaufman Jr11, Andrew Trainer12, Andrew Arther12, Gopal Badlani13, Mihir Desai14, Leo Doumanian14, Alexis E. Te15, Mark DeGuenther16 and Claus Roehrborn17

 

1University of Vermont Medical Center, Burlington, VT, USA, 2Tauranga Urology Research, Tauranga, New Zealand, 3Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, UK, 4San Diego Clinical Trials, San Diego, CA, USA, 5Royal Melbourne Hospital, Melbourne, Vic., Australia, 6Houston Metro Urology, Houston, TX, USA, 7Addenbrookes Hospital, Cambridge University Hospitals, Cambridge, UK, 8Virginia Urology, Richmond, VA, USA, 9Princess of Wales Hospital, Bridgend, Wales, UK, 10Urology Associates, P.C., Englewood, CO, 11Albany Medical College, Albany, NY, 12Adult Pediatric Urology and Urogynecology, P.C., Omaha, NE, 13Wake Forest School of Medicine, Winston-Salem, NC, 14Institute of Urology, University of Southern California, Los Angeles, CA, 15Weill Cornell Medical College, New York, NY, 16Urology Centers of Alabama, Birmingham, AL, and 17Department of Urology, UT Southwestern Medical Center, University of Texas Southwestern, Dallas, TX, USA

 

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Abstract

Objective

To test the hypothesis that benign prostatic hyperplasia (BPH) robotic surgery with aquablation would have a more pronounced benefit in certain patient subgroups, such as men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH.

Methods

We conducted prespecified and post hoc exploratory subgroup analyses from a double‐blind, multicentre prospective randomized controlled trial that compared transurethral resection of the prostate (TURP) using either standard electrocautery vs surgery using robotic waterjet (aquablation) to determine whether certain baseline factors predicted more marked responses after aquablation as compared with TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien–Dindo persistent grade 1 or grade ≥2 surgical complications.

Results

For men with larger prostates (50–80 g), the mean IPSS reduction was four points greater after aquablation than after TURP (P = 0.001), a larger difference than the overall result (1.8 points; P = 0.135). Similarly, the primary safety endpoint difference (20% vs 46% [26% difference]; P = 0.008) was greater for men with large prostate compared with the overall result (26% vs 42% [16% difference]; P = 0.015). Postoperative anejaculation was also less common after aquablation compared with TURP in sexually active men with large prostates (2% vs 41%; P < 0.001) vs the overall results (10% vs 36%; P < 0.001). Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post‐void residual urine volume.

Conclusions

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. The standardized, robotically executed, surgical approach with aquablation may overcome the increased outcome variability in more complex anatomy, resulting in superior symptom score reduction.

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Editorial: A novel robotic procedure for bladder outlet obstruction

We have become used to talking about robotic surgery in urology when we really mean robot‐assisted surgery. The novel aquablation procedure (AquaBeam®) for bladder outlet obstruction (BOO) described by Plante et al. [1] is executed by a robotically controlled waterjet system, conducting a pre‐planned image‐guided resection once the radiological parameters have been entered into the system. This is performed under real‐time ultrasonography guidance. It will deliver a standardized way of carrying out the surgery and will, to a large extent, take away the surgical learning curve whilst introducing a new imaging learning curve.

The present study [1] is an analysis of pre‐planned and exploratory subsets of patients from the WATER study [2], and confirms data from earlier studies [3,4]. The study suggests that, compared with TURP, aquablation is particularly effective in improving both LUTS and bother in the medium‐sized to larger prostate (50–80 mL) and in potentially more challenging prostates such as those with large middle lobes or middle lobe obstruction (judged at pre‐procedure cystoscopy).

It is suggested that the ability to map the resection plane surgically may enable the preservation of key anatomical landmarks and preserve normal sexual function. In this study, anejaculation occurred in only 2% of patients with larger prostates (>50 mL) in the aquablation group compared with 41% of comparable patients undergoing TURP (P < 0.001). The rate of anejaculation however appeared relatively higher in the overall aquablation group, at 10%, compared with 36% in the overall TURP group (P < 0.001). A prostate volume between 30 and 80 mL was an inclusion criterion for the WATER study. This procedure therefore appears to give the best possible rate of anejaculation in a resective surgical intervention in patients with a larger prostate and may have less advantage in patients with a smaller prostate.

Interestingly, the relative overall symptom relief advantage of aquablation over TURP was also not proven in men with smaller prostates; TURP may be equally effective at removing obstructing tissue in smaller as compared to larger prostates. It is not yet clear whether aquablation would not be recommended for prostates below a certain size. In the more recent WATER II study in 101 men with a mean prostate volume of 107 mL, aquablation was also shown to be feasible and safe in men with large prostates (80–150 mL) [5].

There will always be a possible downside to novel treatments and this may relate to poor radiological data entry which may, in turn, lead to sphincter damage, although this has not been an issue in the carefully controlled studies to date. There are also reports of troublesome postoperative bleeding in some cases, although haemostasis can be effectively achieved via a catheter balloon tamponade and traction device or by electrocautery [5,6].

Unlike most other surgical treatments for BOO, the resection times for aquablation are almost independent of prostate volume, although the overall operating time is similar to that of TURP, with the majority of the time being spent in the set up and image planning.

The principal study (WATER) [2] on which this sub‐analysis by Plante et al. is based is an example of a high‐quality randomized controlled trial but still represents data on only 116 patients undergoing aquablation and 65 undergoing TURP; therefore, more randomized controlled trial data and long‐term effectiveness studies are clearly needed. Formal urodynamic studies and trials in patients with even larger prostates would also be appropriate. In addition, there are still few published data on the cost‐effectiveness of aquablation, although it is likely to be in the range of higher‐cost laser ablation therapies.

With better radiology and machine learning or artificial intelligence, this technique may lead to truly standardized BOO surgery with more complete resection and may thereby reduce outcome variability.

References

  1. Plante, MGilling, PBarber, N et al. Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial. BJU Int 2019123651– 60
  2. Gilling, PBarber, NBidair, M et al. WATER: a double‐blind, randomized, controlled trial of Aquablation® vs transurethral resection of the prostate in benign prostatic hyperplasia. J Urol 20181991252– 61
  3. Gilling, PReuther, RKahokehr, A et al. Aquablation ‐ image‐guided robot‐assisted waterjet ablation of the prostate: initial clinical experience. BJU Int 2016117923– 9
  4. Gilling, PAnderson, PTan, AAquablation of the prostate for symptomatic benign prostatic hyperplasia: 1‐year results. J Urol 20171971565– 72
  5. Desai, MBidair, MBhojani, N et al. WATER II (80‐150 mL) procedural outcomes. BJU Int 2019;123106– 12
  6. Aljuri, NGilling, PRoehrborn, CHow I do it: balloon tamponade of prostatic fossa following Aquablation. Can J Urol 2017248937– 40

 

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

 

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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).

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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: Multicentre international experience of 532‐nm laser PVP with GreenLight XPS in men with very large prostates

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.

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

Roger Valdivieso*, Pierre‐Alain Hueber*, Malek Meskawi*, Eric Belleville*, Khaled Ajib*, Franck Bruyere, Alexis E. Te, Bilal Chughtai, Dean Elterman§, Vincent Misraiand Kevin C. Zorn*

 

*Division of Urology, Centre Hospitalier de lUniversite de Montreal (CHUM), Montreal, QC, Canada, Department of Urology, CHU, Tours, France, Department of Urology, Cornell University, New York, NY, USA, §Department of Urology, University of Toronto, Toronto, ON, Canada, and Department of Urology, Clinique Pasteur, Toulousse, France

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Abstract

Objectives

To describe peri‐operative results, functional outcomes and complications of laser photoselective vaporization, using the GreenLight system, of prostate glands ≥200 mL in volume.

Methods

Retrospective analysis of a prospectively maintained multicentre database was performed to select a subgroup of patients with very large prostates (volume ≥200 mL) treated with the GreenLight XPS laser. A subgroup of patients with prostate volumes 100–200 mL was used for comparison. International Prostate Symptom Score, maximum urinary flow rate, postvoid residual urine volume and prostate‐specific antigen levels were measured at 6, 12, 24, 36 and 48 months. Durability was evaluated using benign prostatic hyperplasia re‐treatment rate at 12, 24 and 36 months. Additionally, complications were recorded using Clavien–Dindo classification.

Results

A total of 33 patients (38%) had prostates ≥200 mL. Baseline characteristics were similar between patients with prostates ≥200 mL and those with prostates 100–200 mL. Patients with very large prostates (≥200 mL) had longer operating times (129 vs 93 min), less energy delivered, a greater number of fibres used (3 vs 2) and a higher conversion rate to transurethral resection of the prostate (16% vs 4%). In terms of complications and functional outcomes, we did not find any differences between the groups. Retreatment rate was also comparable.

Conclusions

Our results show that PVP GreenLight XPS‐180W is an acceptable technique for very large prostates (≥200 mL); however, operating times, energy delivery, fibres used and conversion to TURP are a concern in this particular subgroup. This should be used for patient counselling and surgery planning.

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Re: Use of 5α-reductase inhibitors for BPH and risk of high-grade PCa: A French population-based study

Letter to the Editor

Re: Use of 5α-reductase inhibitors for benign prostate hypertrophy and risk of high-grade prostate cancer: A French population-based study

Sir,

We read with interest the article entitled “Use of 5α-reductase inhibitors for benign prostate hypertrophy and risk of high-grade prostate cancer: A French population-based study” by Scailteux et al. [1]. We appreciate that patients should be informed about the high-grade disease that can develop in patients treated with 5-alpha reductase inhibitor for longer than 2 years.

However, we do not think that the use of the “benign prostatic hypertrophy” phrase, which has been used in nine places, is not correct when the histopathology of the disease is considered. Hypertrophy refers to an increase in cell size, while hyperplasia refers to an increase in cell number. For many years, physicians believed that this condition was caused by an increase in the size of certain cells in the prostate gland. However, studies and histopathological evaluations have shown that this is not a hypertrophy but hyperplasia with new dyes and techniques [2]. “Benign Prostate Hyperplasia” (BPH) is a histopathologically correct expression of benign prostatic enlargement that causes symptoms of lower urinary tract in men. Because the proliferation of stromal and glandular elements is involved in the histopathology of BPH.

When the references made using “hypertrophy” in the article were examined, it was seen that “hypertrophy” was not used in the studies of McConnell et al., and “hyperplasia” was used in both of the articles [3,4]. When the available literature on BPH was searched, it was observed that “hyperplasia” was used and abandonment of the term “hypertrophy” was observed.

As a result, we aimed to warn the editor not to make a clear terminology error in the British Journal of Urology International (BJUI), a respected journal in the field of urology.

Fatih Özkaya, Yılmaz Aksoy and Azam Demirel

Ataturk University Medical Faculty, Department of Urology, Erzurum, Turkey

Read the article

 

References

  1. Scailteux, L.M. et al. Use of 5alpha-reductase inhibitors for benign prostate hypertrophy and risk of high-grade prostate cancer: A French population-based study. BJU Int, 2018.
  2. Vinay Kumar, Abul K. Abbas and Jon C. Aster Male Genital System and Lower Urinary Tract. Robbins Basic Pathology Tenth ed.,2018, p.691-712
  3. McConnell, J.D. et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group. N Engl J Med, 1998. 338(9): p. 557-63.
  4. McConnell, J.D. et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med, 2003. 349(25): p. 2387-98.

 

Article of the Month: The UK‐ROPE Study

Every Month, the Editor-in-Chief selects an Article of the Month 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. retainedfirefighter provides more articles like this one. Follow for more articles like this one songsforromance .

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.

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

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity‐matched comparison with transurethral resection of the prostate (the UK‐ROPE study)

 

Alistair F. Ray*, John Powell†‡, Mark J. Speakman§, Nicholas T. LongfordRanan DasGupta**, Timothy Bryant††, Sachin Modi††, Jonathan Dyer‡‡, Mark Harris‡‡Grace Carolan-Rees* and Nigel Hacking††

 

*Cedar, Cardiff University/Cardiff and Vale University Health Board, Cardiff, Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, §Department of Urology, Taunton and Somerset NHS Trust, Taunton, SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London, **Department of Urology, St. MaryHospital, Imperial College Healthcare NHS Trust, London, ††Department of Interventional Radiology, and ‡‡Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

 

Read the full article

Abstract

Objectives

To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP).

Patients and Methods

As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK‐ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post‐procedure, and complication data post‐PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non‐inferiority analysis on propensity‐score‐matched patient pairs. The clinical results and urological measurements were performed at clinical sites. If you want more articles like this one follow us at salbreux-pesage . IPSS and other questionnaire‐based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK‐ROPE study database.

Results

The results showed that PAE was clinically effective, producing a median 10‐point IPSS improvement from baseline at 12 months post‐procedure. PAE did not appear to be as effective as TURP, which produced a median 15‐point IPSS score improvement at 12 months post‐procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality‐of‐life (QoL) improvement, there was no evidence of PAE being non‐inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post‐procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non‐target embolization that presented as self‐limiting penile ulcers. Additional patient‐reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy‐one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights.Here excelpasswordrecovery you can check the best articles of the month.

Conclusion

Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone‐beam computed tomography is encouraged to improve operator confidence and minimize non‐target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients’ symptoms, requirements and anatomical variation.

Read more articles of the week

 

Editorial: Prostate Artery Embolization

Andrea Tubaro, in his editorial for European Association of Urology 2006 [1], discussed the paradigm shift in the surgical management of BPH from open surgery to TURP, and postulated that more refined and less invasive techniques would further dictate the treatment pathway to reduce cost, manage more high-risk surgical cases and reduce blood loss in a population that increasingly is on antithrombotic and anticoagulant medication, to ease the management of large prostates, and to manage BPH as a day case procedure [1].

Interventional radiology has been at the forefront of minimally invasive procedures. In 1953, Seldinger [2] published his ingenious method of introducing a catheter into the vascular system after obtaining needle access and, 10 years later, Dotter recognized the potential of catheters to be used in performing intravascular surgery [3]. Superselective prostate artery embolization (PAE) was first described by DeMeritt et al. [4]. Pisco et al. [5] from Portugal and Carnevale et al. [6] from Brazil have rightly been credited with the development of the clinical service for PAE in BPH. The study by Pisco et al. in 2016, in 630 consecutive patients with moderate to severe LUTS refractory to medical therapy for at least 6 months, showed 81.9% medium-term and 76.3% long-term clinical success rates, with no urinary incontinence or sexual dysfunction reported. Carnevale et al. [6], in 2014, described a modified PAE technique that can lead to greater ischaemia and infarction of the prostate gland with the possibility of better clinical outcomes [6].

In this edition of BJUI, the UK Register of Prostate Embolization (ROPE) study [7] provides evidence for the efficacy and safety for PAE for LUTS secondary to BPH and makes an indirect comparison with TURP. What is strikingly unique and to be applauded in this registry is the collaboration between the British Society of Interventional Radiology, the BAUS and National Institute of Clinical Excellence (NICE).

A total of 305 patients across 17 UK centres were enrolled, and results were analysed over 12 months. They noted that patients who underwent PAE had a statistically significant improvement in urinary flow rate and reduction in prostate volume after the procedure. In terms of IPSS and quality-of-life improvement, there was no evidence of PAE being non-inferior to TURP. Seventy-one percent of PAE cases were performed as outpatients or day cases. By contrast, 80% of TURPs required at least one night of hospital stay and a majority two nights [7].

In April 2018, NICE revised their guidelines and have now approved PAE with certain recommendations [8].

The key to successful PAE, in our opinion, is careful patient selection. At our centre, we receive tertiary referrals of patients with very large prostates, many of whom are comorbid and elderly. We embraced the option of PAE and were delighted to be able to contribute a number of cases to the ROPE study. Our overall experience is now in excess of 200 cases and we are aware that some patients will do well, others less well. It is becoming clearer who those patients may be; those who do well tend to be those with the larger prostate with large lateral lobes and adenomatous predominant BPH, without a significant middle lobe, with big prostate vessels and with lower risk of significant renal insufficiency. The large middle lobes can ball-valve and still obstruct, and preoperative arterial CT could identify those with heavily calcified, severely diseased internal iliac arteries that may be difficult to embolize. Nonetheless, those patients who are at highest risk from surgery and those who wish to minimize the risks of sexual dysfunction or incontinence may justifiably opt for PAE as a less invasive outpatient procedure. And why should they not? For many, simply the opportunity to avoid long-term medication with a-blockers or 5-a-reductase inhibitors is the real benefit, and undergoing PAE does not exclude one from surgery afterwards.

Level 1 evidence is of course a fundamental requirement for a change in definitive practice; the ROPE study is a comparative cohort of two fundamentally different procedures. Our institute is a surgical centre for the management of massive BPH and we are convinced that PAE has a place in the management of some of our patients, but could prevention be better than cure? Ambitious it may be, but who is to say whether early PAE in symptomatic patients might reduce the progression of clinical BPH, avoiding the morbidity and cost of long-term medical treatment culminating in surgery. Perhaps the real challenge highlighted by the ROPE study is that the time has come to consider a randomized controlled trial of prostate embolization vs early non-surgical treatment of BPH (short title ‘PREVENT-BPH’), with randomization to PAE or either a-blockers and/or 5-a-reductase inhibitors or placebo. The ROPE study suggests that PAE at the least deserves a randomized controlled trial including it vs other non-invasive treatments.

Tarun Sabharwal and Rick Popert
Guy’s and St Thomas’ Hospital, London, UK

Read the full article

References

  1. Tubaro A. BPH treatment: a paradigm shift. Eur Urol 2006; 49: 939–41
  2. Seldinger SI. Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta Radiol 1953; 39: 368–76
  3. Dotter CT, Judkins MP. Transluminal treatment of atherosclerotic obstructions: description of a new technique and preliminary report of its applications. Circulation 1964; 30: 654–70
  4. DeMeritt JS, Elmasri FF, Esposito MP, Rosenberg GS. Relief of benign prostatic hyperplasia-related bladder outlet obstruction after transarterial polyvinyl alcohol prostate embolization. J Vasc Interv Radiol 2000; 11: 767–70
  5. Pisco JM, Bilhim T, Pinheiro LC et al. Medium-and long-term outcome of prostate artery embolization for patients with benign prostatic hyperplasia: results in 630 patients. J Vasc Interv Radiol 2016; 27: 1115–22
  6. Carnevale FC, Moreira AM, Antunes AA. The “PErFecTED Technique”: proximal embolisation first, then embolise distal for benign prostatic hyperplasia. Cardiovasc Intervent Radiol 2014; 37: 1602–5
  7. Ray AF, Powell J, Speakman MJ et al. Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study). BJU Int 2018; 122: 270–82
  8. NICE Guidance. Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia. BJU Int 2018;121: 825-34

 

Residents’ Podcast: UK‐ROPE Study

Maria Uloko is a Urology Resident at the University of Minnesota Hospital and Giulia Lane is a Female Pelvic Medicine and Reconstructive Surgery Fellow at the University of Michigan

In this podcast they discuss the BJUI Article of the Month ‘Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity‐matched comparison with transurethral resection of the prostate (the UK‐ROPE study)’

 

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity‐matched comparison with transurethral resection of the prostate (the UK‐ROPE study)

 

Alistair F. Ray*, John Powell†‡, Mark J. Speakman§, Nicholas T. LongfordRanan DasGupta**, Timothy Bryant††, Sachin Modi††, Jonathan Dyer‡‡, Mark Harris‡‡Grace Carolan-Rees* and Nigel Hacking††

 

*Cedar, Cardiff University/Cardiff and Vale University Health Board, Cardiff, Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, §Department of Urology, Taunton and Somerset NHS Trust, Taunton, SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London, **Department of Urology, St. MaryHospital, Imperial College Healthcare NHS Trust, London, ††Department of Interventional Radiology, and ‡‡Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

 

Read the full article

Abstract

Objectives

To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP).

Patients and Methods

As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK‐ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post‐procedure, and complication data post‐PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non‐inferiority analysis on propensity‐score‐matched patient pairs. The clinical results and urological measurements were performed at clinical sites. IPSS and other questionnaire‐based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK‐ROPE study database.

Results

The results showed that PAE was clinically effective, producing a median 10‐point IPSS improvement from baseline at 12 months post‐procedure. PAE did not appear to be as effective as TURP, which produced a median 15‐point IPSS score improvement at 12 months post‐procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality‐of‐life (QoL) improvement, there was no evidence of PAE being non‐inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post‐procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non‐target embolization that presented as self‐limiting penile ulcers. Additional patient‐reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy‐one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights.

Conclusion

Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone‐beam computed tomography is encouraged to improve operator confidence and minimize non‐target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients’ symptoms, requirements and anatomical variation.

Read more articles of the week

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