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

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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).

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Editorial: Aquablating urological skills

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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 2019; 123: 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 2010; 15: 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 2007; 177: 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 2015; 68: 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 2018; 5: 1252–61

 

Re: Millin’s prostatectomy in the era of ‘Getting It Right First Time’ and Montgomery: exploring variation in clinical practice and consent

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Letter to the Editor

Millin’s prostatectomy in the era of ‘Get it Right First Time’ and Montgomery: exploring variation in clinical practice and consent.

We read with interest the comment in last months BJUI where it was suggested that the Millin retropubic simple prostatectomy for BPH should be confined to history in part because of the Montgomery ruling and the GIRFT programme [1]. GIRFT was designed to identify variations and raise standards of care. The urology report has since been published (it was not available when the original article was written) and Simon Harrison and his team should be congratulated for providing an excellent review of the current state of urology in the UK and identifying recommendations to improve patient care [2]. As surgeons we are acutely aware how the Montgomery ruling has shifted the test for appropriate consent from the “Bolam principle” to a patient orientated process. It is no longer for us to deem what information is relevant to inform the patient and all risks/benefits/alternatives must be outlined. We should all use a detailed, patient-centred, longitudinal approach to consent supplemented with BAUS information leaflets and other resources.

Where we disagree with the authors is to suggest that both of these key events (GIRFT and Montgomery) can be interpreted as justification for not performing a highly effective operation with excellent outcomes. Terence Millin described the transcapsular retropubic simple prostatectomy in 1945 and it revolutionised the management of men with BPH. There are few other procedures that have survived since their inception over 70 years ago in the same form [3] and it remains an established treatment for large glands in European, British and American urological guidelines respectively. More recently the robotic platform has been utilised to perform the technique, although more frequently a transvesical approach is deployed. When performed by well-trained surgeons it remains a procedure that yields very high patient satisfaction and low complication rates. Whilst accepting the cost implications of the slight increased length of stay the authors have failed to discuss the hidden costs of consumables, increased theatre time and further treatments that may be required for the transurethral enucleation procedures.

HES data shows that Millin prostatectomy is not a commonly performed operation. This reflects the fact that massively enlarged prostates are not as common as in the past, partly due to the widespread use of medical therapy and earlier referrals. However, the management of the extreme end of the enlarged benign prostate will always be challenging and we feel that there remains a need to have surgeons with the necessary skills to perform this procedure in the appropriately selected and consented patient. The largest adenoma enucleated by the authors is 980cc (GW) and we would suggest that this would represent a challenge for any transurethral approach. Indeed, the previous Editor of this journal commented in 2008 “some have said that the era of the Millin prostatectomy is over. I very much disagree with this and would not like to see the demise of such a satisfying surgical procedure, with excellent outcome for the patient” [4].

Andrew Chetwood1, Pravin Menezes2, Charles Coker3, Graham Watson4

1Frimley Health NHS Foundation Trust

2Kingston Hospital NHS Trust

3Brighton and Sussex University Hospitals NHS Trust

4East Sussex Hospitals NHS trust

References

  1. Millin’s prostatectomy in the era of ‘getting it Right First Time’ and Montgomery: exploring variation in clinical practice and consent. Malthouse T, Mistry K, Agrawal S. BJU Int 2018;122:171-172
  2. gettingitrightfirsttime.co.uk
  3. Retropubic prostatectomy; a new extravesical technique; report of 20 cases. Millin Lancet. 1945 Dec 1;2(6380):693-6.
  4. Surgery Illustrated – Millin Retropubic Prostatectomy. Fitzpatrick J, BJU Int 2008;102:906-916
Read the article

Reply by the authors

We wholeheartedly agree that the Millin’s is indeed a ‘satisfying surgical procedure, with excellent outcomes for the patient’ and it is not a procedure we would voluntarily relinquish. However as surgeons we should bear in mind the fundamental principles of ‘primum non nocere’ and need to put patient safety above our own wishes to perform a specific operation.  There have been several technological advances since 2008, with HOLEP at the forefront of BPE surgery for large volume glands showing safer and equally effective outcomes.  Indeed Terence Millen was a proponent of transurethral techniques developing his own Millin’s resectoscope, with the retropubic approach only evolving due to a lack of equipment after the world war. He may well have been the first to innovate.

Our article was designed to stimulate a debate around consent, safety, and cost effectiveness in our whole practice. However the principles outlined within GIRFT ideology and the current medicolegal world we live in, remain.   Consent for a Millin’s is clearly an issue with the need to specifically discuss (and document) alternatives including HOLEP, with evidence clearly showing improved safety, lower morbidity and length of stay. Additionally the majority of NHS trusts, have a centre within their region delivering this service and as such not offering HOLEP would not justify performing a Millin’s. Whilst we accept that newer minimally invasive techniques (robotic/laparoscopic with similar safety profiles) also exist and could be retained for the larger glands, we suspect the majority of open retropubic prostatectomies are not for 980cc volume prostates.

Finally, we would argue the fact that HES data shows the Millin’s to be a low volume procedure suggesting many have already changed practice. When considering costs towards consumables, these are incorporated and not in addition to tariffs paid to organisations. As tax paying members of the public and as clinicians we have a responsibility to use our funding and resources wisely. We believe that the literature would benefit from a modern-day case series to better inform this debate. Perhaps we need to define a volumetric cut off above which a retropubic or minimally invasive technique would be justifiable or cost effective?

Sachin Agrawal and Theo Malthouse

Ashford & St Peters NHS Foundation Trust

 

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

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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.

 

Re: Efficacy and safety of PAE for BPH: an observational study and propensity-matched comparison with TUR of the prostate (the UK- ROPE study)

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Letter to the Editor

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)

Sir,

We read the manuscript by Ray and colleagues and congratulate the authors for the effort spent on this remarkable work. To date, this is the first large multicentre study to assess and compare the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) with transurethral resection of the prostate (TURP). We have, however, some concerns regarding the interpretation and reporting of the study that warrant further clarification.

  • It was suggested that the PAE-related learning curve ranges from 10-20 cases. However, even with training and proctorship, the number of PAE each centre had performed to participate in the UK-ROPE Registry was not mentioned. It would be interesting to see a comparison of outcomes between PAE patients who had their procedures performed before and after the learning curve.
  • Unfortunately, due to the large number of centres in UK it was not possible to have a homogenous technique used in the PAE arm. Even considering that the PErFecTED was not used, each centre was allowed to use their own embolization technique.
  • Another technical issue concerns the use of cone-beam CT (CBCT) during the procedures. It is not clear whether CBCT was available and used in every case. For example, it was not mentioned whether penile ulcers were related to embolic agent’s reflux or to anastomoses that were not observed because CBCT was not available or was not used during PAE. All of these issues could be considered bias, however, it has been proven that clinical and imaging success can be achieved with different techniques.
  • Unfortunately, prostate volume measurement data were not available for TURP cases. This information could be important and supportive of the use of TURP, since men are very concerned about prostate volume before and after any therapy.
  • The estimated reported operation rate on and off the 12-month follow-up period was 19.9%. Cases of unilateral embolization, small prostate volume and median lobe enlargement were reported. However, the significance of small prostate volume was not defined, the grade of the median lobe enlargement, as well as if some patients had hypocontractile bladder rather than LUTS. Urodynamic studies might have a key role in this type of evaluation.
  • We understand that transient haematospermia and haematuria should be considered as side effects instead of complications, which could be added to a mail-based questionnaire system used to collect data in the Registry.

The pathophysiology of PAE is probably related to ischemia in the transitional zone of the prostate followed by coagulative necrosis. How was retrograde ejaculation (24.1%) diagnosed in the PAE group? Could it be due to a reduction in ejaculation volume resultant of prostatic tissue death after embolization? Some men stated they had been experiencing retrograde ejaculation prior to PAE due to medication. It seems that ejaculatory status was not captured at baseline. Future investigators should consider the importance of collecting these data preprocedure.

Francisco Cesar Carnevale MD PhD, Andre Moreira de Assis MD and Airton Mota Moreira MD PhD.

Department of Radiology, University of Sao Paulo, Sao Paulo, Brazil.

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Reply by the authors

We thank Carnevale and colleagues for their comments on our study. Regarding the PAE-related learning curve, these data are available and will be published separately. Procedural and screening times and therefore overall radiation dose reduced with increasing experience but there was very little difference in outcome measures in keeping with PAE being a robust technique in many centres and not just the well-known centres of excellence.

Four of the centres were trained and proctored by the Lisbon group and the remaining centres were trained by the University Hospital Southampton IRs using the same technique. The details of catheter and microcatheters used as well as the size and nature of the embolic particles are being published in a subsequent paper. Micro catheters of 2.4Fr and smaller were used in all cases at all centres. The majority of cases were embolized with either particulate PVA (Cook Medical or Boston Scientific) or spherical microspheres (Celonova/Boston Scientific). Cone beam CT was available in almost all centres and was used on the majority of cases. These data are available and are being collated for subsequent publication.

The study protocol and budget allowed normal practice for TURP patients. These did not therefore get formal Urodynamics nor post-surgical imaging and prostate volume measurements. While prostate volume was not formally measured for TURP we recorded resected weights which give some idea of gland volume, though not a reliable measure.

Unilateral embolization, small prostate volume and median lobe enlargement are important co-variates which are being analyzed and will be submitted for publication shortly. All patients having PAE had confirmed obstruction on UDS so hypocontractile bladders were excluded.

We agree that transient haematospermia and haematuria should be considered as side effects instead of complications, and could be added to a mail-based questionnaire system used to collect data in the Registry and we thank Carnevale and colleagues for pointing this out.

Baseline dry or retrograde ejaculation is common in marked prostatic enlargement being treated by alpha blockers such as Tamsulosin. It is a weakness of this study that we did not capture ejaculatory status at baseline. This will be answered in subsequent clinical studies derived from the UK-ROPE dataset.

All of these technical issues were not controlled in our pragmatic study, however, as Carnevale and colleagues note, the study has shown that clinical and imaging success can be achieved with different techniques.

A Ray1, J Powell2,  MJ Speakman3, NT Longford4, R DasGupta5, T Bryant6, S Modi6, J Dyer7, M Harris7, G Carolan-Rees1, N Hacking6

1Cedar, Cardiff University/Cardiff and Vale University Health Board, Cardiff, UK

2Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, UK

3Department of Urology, Taunton and Somerset NHS Trust, Taunton, UK

4SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London, London, UK

5Department of Urology, St. Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UK

6Department of Interventional Radiology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

7Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

 

Article of the Month: The UK‐ROPE Study

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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. Longford, Ranan 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. Mary’s Hospital, 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.

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Infographic: The UK‐ROPE Study

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Infographic: 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)

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Residents’ Podcast: UK‐ROPE Study

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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. Longford, Ranan 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. Mary’s Hospital, 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.

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Article of the Week: TIND implantation in benign prostatic obstruction

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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 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 podcast discussing the paper.

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

3‐Year follow‐up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction

 

Francesco Porpiglia , Cristian Fiori, Riccardo Bertolo, Andrea Giordano, Enrico Checcucci, Diletta Garrou, Giovanni Cattaneo, Stefano De Luca and Daniele Amparore
Division of Urology, Department of Oncology – School of Medicine, San Luigi Hospital, University of Turin, Orbassano (Turin), Italy

 

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Abstract

Objectives

To report 3‐year follow‐up results of the first implantations with a temporary implantable nitinol device (TIND®; Medi‐Tate Ltd., Or Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Patients and Methods

In all, 32 patients with LUTS were enrolled in this prospective study. The study was approved by the local Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) ≥10, peak urinary flow (Qmax) <12 mL/s, and prostate volume <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, and removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to Clavien–Dindo classification), functional results, and quality of life (QoL) were evaluated. Follow‐up assessments were made at 3 and 6 weeks, and 3, 6, 12, 24 and 36 months after the implantation. The Student’s t‐test, one‐way analysis of variance and Kruskal–Wallis tests were used for statistical analyses.

Results

At baseline, the mean (standard deviation, sd) patient age was 69.4 (8.2) years, prostate volume was 29.5 (7.4) mL, and Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14–23) and the QoL score was 3 (3–4). All the implantations were successful, with a mean total operative time of 5.8 min. No intraoperative complications were recorded. The change from baseline in IPSS, QoL score and Qmax was significant at every follow‐up time point. After 36 months of follow‐up, a 41% rise in Qmax was achieved (mean 10.1 mL/s), the median (IQR) IPSS was 12 (6–24) and the IPSS QoL was 2 (1–4). Four early complications (12.5%) were recorded, including one case of urinary retention (3.1%), one case of transient incontinence due to device displacement (3.1%), and two cases of infection (6.2%). No further complications were recorded during the 36‐month follow‐up.

Conclusions

The extended follow‐up period corroborated our previous findings and suggests that TIND implantation is safe, effective and well‐tolerated, for at least 36 months after treatment.

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Editorial: The trials of doing trials: will the prostatic stent rise from the dead?

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A further re‐engineering of the prostatic stent (temporary implantable nitinol device [TIND®, Medi‐Tate Ltd., Israel]) is reported by Porpiglia et al. 1 in this edition of the BJUI. Enthusiasm for novel ‘minimally invasive’ treatments for BPH/LUTs has surged recently, with new options supported by strong data becoming available 2, 3. That interest reflects the continuing desire of our patients to seek alternatives to the standard drug or surgical therapies.

The success of UroLift® (Neotract, Pleasanton, CA, USA) in satisfying the rigour of the regulatory bodies (especially the Food and Drug Administration [FDA] in the USA and National Institute for Health and Care Excellence [NICE] in the UK) and the recent merger/acquisition of Neotract by Teleflex Inc. for a sum potentially exceeding 1 billion dollars, indicates the rewards available for a novel treatment with convincing data. Not surprisingly, this has stimulated innovators, so there is a veritable tsunami of new treatments approaching us. The rewards are certainly encouraging, but it is worth remembering that the difficulties and cost of reaching market and the point of sale are now enormous.

The TIND stent is implanted endoscopically and then gradually distends to cause three linear pressure necrosis effects within the prostatic urethra and bladder neck tissues, before it is removed at approximately 5–7 days by a second, minor and office‐based procedure.

However, this report is simply a repeat of the initial case series from 2015 4, just with follow‐up to 36 months. An initial report is legitimate in order to show primarily safety and with effectiveness as a secondary outcome measure. I see limited value in a follow‐up report of a device that has already been superseded by a second version, which is currently being assessed in the more rigorous studies that we, our patients, and regulators require.

Even so, there are some important messages and some inconsistencies. Porpiglia et al. 1 are, firstly, to be commended for successfully following their patients out to 3 years with essentially complete data sets. That is remarkable. Although the TIND seems safe, there was one serious complication (a prostatic abscess associated with arrhythmia, sepsis and hyperglycaemia, which required 10 days of inpatient care). About 10% of men restarted medical therapy, but are not ‘failures’, as failures are defined only as those requiring surgical treatment. The prostate size in this small cohort is also surprisingly small compared to the initial studies of other novel devices (29.5 vs 50 mL for UroLift in the initial report) 5. It is also surprising that even though all were on α‐blockers and a substantial proportion were taking 5α‐reductase inhibitors that there is no sexual or especially ejaculatory dysfunction in any of the 19 sexually active men before or after TIND implantation. They appear to have surprisingly resilient ejaculatory function and one wonders why or how? The population studied may therefore not be representative of men we meet in our clinics. Nevertheless, the safety and effectiveness of the original TIND stent do seem reasonable and many of us will await the definitive ‘pivotal’ randomised controlled studies of the successor device with great interest.

For the TIND to find a place in our range of treatments, we urologists, our patients, and regulators of healthcare, now need to see proper randomised controlled trials, preferably incorporating a sham arm and eventually comparisons with TURP. Ideally, the TIND should also be compared to UroLift and to steam injection (Rezūm®; NxThera, Inc., Maple Grove, MN, USA). But who will pay for these studies, even if the regulators insist on them? Funding the required studies is now a major financial challenge to any new device in development. Those studies cost more than we think. A survey of >200 MedTech companies in 2010 suggested device development costs up to 100 million dollars (the majority spent on FDA‐dependent or related activities) but for UroLift total development spend was nearly 240 million. Unfortunately, even innovative and potentially useful devices will struggle to overcome the double jeopardy of regulatory hurdles and obtaining the finance required to clear them. I wish the developers of TIND well and hope there is adequate funding. Today, developers need deep pockets to perform the proper studies correctly.

 

Tom McNicholas
Pinehill Hospital, Hitchin, Herts, UK

References

 

  • 1 Porpiglia F, Fiori C, Bertolo R et al. 3‐Year follow‐up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction. BJU Int2018; 122: 106–12

 

  • 2 Roehrborn CG, Barkin J, Gange SN et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol 2017; 24: 8802–13

 

  • 3 McVary KT, Roehrborn CG. Three‐year outcomes of the prospective, randomized controlled Rezūm System study: convective radiofrequency thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Urology 2018; 111: 1–9

 

  • 4 Porpiglia F, Fiori C, Bertolo R, Garrou D, Cattaneo G, Amparore D. Temporary implantable nitinol device (TIND): a novel, minimally invasive treatment for relief of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH): feasibility, safety and functional results at 1 year of follow‐up. BJU Int 2015; 116: 278–87

 

  • 5 Woo HH, Chin PT, McNicholas TA et al. Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int 2011; 108: 82–8

 

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