Tag Archive for: Article of the Week

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Editorial: Somatic-autonomic neurorrhaphy for erectile function restoration after radical prostatectomy

The authors of the present study [1] are to be commended for their efforts in describing their 3-year experience with a novel bilateral end-to-side somatic-autonomic neurorrhaphy intended to restore erectile function at least 24 months after radical prostatectomy, after which spontaneous return of erectile function is unlikely [2]. Using the principles of brain plasticity and neurotization, the authors describe, for the first time, bilateral sural neurografting between the femoral nerve and both the corpus cavernosum and the dorsal nerve of the penis to achieve penile re-innervation. The employed side-to-end neurorrhaphy theoretically limits functional damage during axonal sprouting, reinforces sensory–motor communications to the cavernous nerves, and promotes glans penis sensitivity, although direct evidence of these physiological and clinical outcomes is yet to be demonstrated. Furthermore, the authors astutely capitalize on the potential advantages of using a femoral donor nerve, including its proximity to the proximal penis, its diameter, the sufficient axon count, the mixed composition of sensory and motor fibres, and its secretion of acetylcholine which is an essential neurotransmitter in the nitric oxide-mediated pathway leading to penile tumescence.

What is especially singular about this technique is its application months after radical prostatectomy following demonstrated post-surgical loss of erectile function. Previous studies have focused on unilateral or bilateral sural [3-6] or genitofemoral [7] neurografting of the cavernous nerves at the time of radical prostatectomy before post-surgical loss of erectile function could be substantiated. Such studies have had mixed results, attributable in part to the success of the nerve-sparing radical prostatectomy technique in the hands of experienced high-volume surgeons [3, 6], and post-surgical exposure of the cavernous nerves to androgen deprivation or radiation therapy in some patients [3, 5]. Whereas post-radical prostatectomy re-innervation of the cavernous nerves may not be feasible or efficacious secondary to post-surgical and post-radiation fibrosis, the described technique does not require abdominopelvic access, is associated with a quick recovery time and minimal complications, and does not preclude subsequent penile prosthesis implantation if necessary.

The results of the present study show significant improvement in general sexual satisfaction from baseline to 6 months post intervention corresponding to achievement of flaccid erection for all patients; significant improvement in erectile dysfunction from baseline to 12 months post intervention corresponding to achievement of semi-rigid or rigid erections in 8/10 patients; and significant improvement in satisfaction with sexual intercourse from baseline to 18 months post intervention corresponding to achievement of penetration for 6/10 patients. It should be noted, however, that administration of the Clinical Evolution of Erectile Function instrument at 36 months postoperatively may have introduced recall bias in patient-reported erectile function. As would be expected, no significant differences were noted in sexual desire or orgasm satisfaction during the study period. These results were achieved without evidence of atrophy, fibrosis, or significant differences in vascular flow of the bilateral corpora cavernosa; and with minimal complications over the study period.

The present study provides preliminary data regarding the safety, feasibility and efficacy of bilateral sural neurografting between the femoral nerve and both the corpus cavernosum and the dorsal nerve of the penis to restore post-radical prostatectomy erectile function in a limited pool of 10 men. If these preliminary results are substantiated with long-term follow-up in a significant number of patients, it should prompt multi-institutional collaborations to appropriately power comparative effectiveness analyses of post-radical prostatectomy neurorrhaphy, such as the described technique to a regulatory-approved ethical sham intervention, vacuum assist device therapy, urethral suppository therapy, or intracavernosal injection therapy. Ideally, patients should be matched or statistical analyses should be controlled for patient age, relevant comorbidities, prostate cancer stage, pre-radical prostatectomy erectile function, nerve-sparing radical prostatectomy technique, androgen deprivation therapy, radiation therapy, response to phosphodiesterase-5 inhibition, and time interval between radical prostatectomy and intervention. Such multi-institutional studies would benefit from: standardized protocols for preoperative evaluation, operative technique, peri-operative care and post-surgical sexual stimulation; repeated-measure analyses of both objective assessments of the quality and duration of penile tumescence, as well as patient-reported outcomes of erectile function and disease-specific quality of life using validated instruments; report of oncological outcomes; and long-term follow-up. We would encourage the authors to produce a technical video demonstrating their technique so that it may be attempted and validated by other programmes. Urological surgeons with expertise in oncology, sexual function, and reconstruction may collaborate and pool patient data to achieve high-powered quality studies of novel techniques, such as the one described in the present study, for post-radical prostatectomy erectile function restoration.

Jaime A. Cavalloand Ashutosh K. Tewari, Chairman
Milton and Carroll Petrie Department of Urology, Icahn School of Medicine at M ount Sinai, New York, NY, USA

 

How to Cite

Cavallo, J. A. and Tewari, A. K. (2017), Somatic-autonomic neurorrhaphy for erectile function restoration after radical prostatectomy. BJU International, 119: 816–818. doi: 10.1111/bju.13858

References

 

 

 

 

 

Article of the Month: GreenLight XPS for treating benign prostatic hyperplasia

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.

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.

GreenLight XPS for treating benign prostatic hyperplasia

Read the full article

This National Institute for Health and Care Excellence (NICE) guidance is the current, unaltered NICE guidance at time of publication. BJUI publishes selected NICE guidance relevant to urologists to extend their distribution and promote best practice.

 

 Recommendations

  • 1.1
    The case for adopting GreenLight XPS for treating benign prostatic hyperplasia is supported in non-high-risk patients. GreenLight XPS is at least as effective in these patients as transurethral resection of the prostate (TURP), but can more often be done as a day-case procedure, following appropriate service redesign.

 

  • 1.2

    There is currently insufficient high-quality, comparative evidence to support the routine adoption of GreenLight XPS in high-risk patients, that is those who:

    • have an increased risk of bleeding or
    • have prostates larger than 100 ml or
    • have urinary retention.

    NICE recommends that specialists collaborate in collecting and publishing data on the comparative effectiveness of GreenLight XPS for high-risk patients to supplement the currently limited published evidence.

 

  • 1.3
    Cost modelling indicates that in non-high-risk patients, cost savings with GreenLight XPS compared with TURP are determined by the proportion of procedures done as day cases. Assuming a day-case procedure rate of 36%, and that the GreenLight XPS console is provided at no cost to the hospital (based on a contracted commitment to fibre usage), the estimated cost saving is £60 per patient. NICE’s resource impact report estimates that the annual cost saving for the NHS in England is around £2.3 million. In a plausible scenario of 70% of treatments being done as day cases, the cost saving may be up to £3.2 million.

 

  • 1.4
    NICE recommends that hospitals adopting GreenLight XPS plan for service redesign to ensure that day-case treatment can be delivered appropriately.

 

Read more articles of the week

 

Editorial: Celebrating BAUS and NICE Guidance

On behalf of the BAUS Council, I am delighted to write this editorial looking forward to the 73rd annual meeting of the BAUS, which will be held in Glasgow from 26 to 28 June. In response to feedback we had from delegates following BAUS 2016 and the successful European Association of Urology meeting in London this March, we have changed the format and duration of the meeting, ensuring that it has a distinct feel, reflecting the best of British Urology.

With Brexit looming and the precarious state of NHS finances, the continuing challenge for all of us working in the NHS is to deliver high-quality care within available resources, while embracing the latest evidence informing clinical practice. This month’s BJUI sees the first publication of National Institute for Health and Care Excellence (NICE) guidance on urological topics – ‘MTG29 GreenLight XPS for treating benign prostatic hyperplasia’ [1]. NICE has a fantastic track record in publishing highly regarded evidence-based syntheses across the breath of medicine and this guidance will stimulate the development and adoption of Greenlight laser for treating BPH as a day case procedure in the UK.

Assessing and critiquing new evidence are key elements of the annual BAUS meeting and this year is no exception. In all, 535 abstracts were submitted of which 157 will be presented. Whilst much of our clinical practice is of a high quality, analysis of the work done by the ‘Getting it right first time’ (GIRFT) team has shown a wide variation in practice for many common conditions in Urology. Simon Harrison, who leads the GIRFT team, will be giving an update on the progress of the work in a session looking at how standards can be applied in the real world at a session on Tuesday 27 June, entitled ‘Urology standards and the real world’.

On Monday 26 June, Academic Urology, Andrology and Genito-Urethral Surgery (AGUS), and Female, Neurological and Urodynamic Urology (FNUU) will be holding their annual meetings. State of the art lectures include Professor Trinity Bivalacqua speaking on ‘Molecular genetics and the prospect for future treatment strategies in Urology’. The AGUS section will focus on the genital emergencies consultation and the future of andrology in the UK, shedding light on specialist commissioning and training in the speciality. Highlights of the FNUU section meeting will include an update on meshes and tapes and the medicolegal consequences of adverse outcomes.

British urology has played a pivotal role in our understanding of the diagnosis and management of prostate cancer. Reflecting this, a point-counterpoint debate will take place on Tuesday 27 June, with Caroline Moore and Paul Cathcart debating the necessity for prostate biopsy in patients with Prostate Imaging Reporting and Data System (PI-RADS) 1and 2 lesions seen on MRI, drawing on evidence from the recent PROstate MRI Imaging Study (PROMIS) trial. On Wednesday 28, Noel Clarke will report on the latest news from the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE) study, which to date has recruited >9000 patients. New evidence from the study is likely to herald a change in the care of our patients with metastatic prostate cancer.

In addition to state of the art papers, we are delighted to have a number of key opinion leaders attending the meeting. Reflecting the public’s high expectations and pressures on clinicians, Professor David Speigelhalter, Winton Professor for the Public Understanding of Risk at the University of Cambridge, will speak on the nature of risk and uncertainty in clinical practice. The BJUI Guest lecture will be delivered by David Prior (Parliamentary Under Secretary of State in the House of Lords). With the recent publication of The Long-term Sustainability of the NHS and Adult Social Care report [2], he is uniquely placed to give a perspective on the future direction of the NHS.

For the first time at our meeting there will be a session entitled ‘When things go wrong’. This session will focus on the impact of adverse events and burnout on Urologists, which promises to be insightful and thought provoking. With plenty of science, innovations in urological care and some politics, BAUS 2107 promises to be a fascinating meeting. I look forward to seeing you there.

Kieran OFlynn

 

President of the BAUS

 

Read the full article

How to Cite

O’Flynn, K. (2017), Celebrating BAUS and NICE Guidance. BJU International, 119: 815. doi: 10.1111/bju.13899

 

References

1 National Institute for Health and Care Excellence.MTG29 GreenLight XPS for treating benign prostatic hyperplasia.BJU Int 2017;119:82330

 

2 House of Lords.The Long-term Sustainability of the NHS and Adult Social Care, 5 April 2017. Available at: https://www.publications.parliament.uk/pa/ld201617/ldselect/ldnhssus/151/151.pdf. Accessed 24 April 2017

 

Residents’ Podcast: NICE Guidance – GreenLight XPS for treating benign prostatic hyperplasia

Veeru Kasivisvanathan

SpR in Urology & NIHR Doctoral Fellow, University College London & University College Hospital London.

Read the full article

This National Institute for Health and Care Excellence (NICE) guidance is the current, unaltered NICE guidance at time of publication. BJUI publishes selected NICE guidance relevant to urologists to extend their distribution and promote best practice.

 Recommendations

  • 1.1
    The case for adopting GreenLight XPS for treating benign prostatic hyperplasia is supported in non-high-risk patients. GreenLight XPS is at least as effective in these patients as transurethral resection of the prostate (TURP), but can more often be done as a day-case procedure, following appropriate service redesign.
  • 1.2

    There is currently insufficient high-quality, comparative evidence to support the routine adoption of GreenLight XPS in high-risk patients, that is those who:

    • have an increased risk of bleeding or
    • have prostates larger than 100 ml or
    • have urinary retention.

    NICE recommends that specialists collaborate in collecting and publishing data on the comparative effectiveness of GreenLight XPS for high-risk patients to supplement the currently limited published evidence.

  • 1.3
    Cost modelling indicates that in non-high-risk patients, cost savings with GreenLight XPS compared with TURP are determined by the proportion of procedures done as day cases. Assuming a day-case procedure rate of 36%, and that the GreenLight XPS console is provided at no cost to the hospital (based on a contracted commitment to fibre usage), the estimated cost saving is £60 per patient. NICE’s resource impact report estimates that the annual cost saving for the NHS in England is around £2.3 million. In a plausible scenario of 70% of treatments being done as day cases, the cost saving may be up to £3.2 million.
  • 1.4
    NICE recommends that hospitals adopting GreenLight XPS plan for service redesign to ensure that day-case treatment can be delivered appropriately.
Read more articles of the week

Article of the Week: QoL outcomes from the PATCH trial evaluating LHRHa versus tE2 for ADT in PCa

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.

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

Quality-of-life outcomes from the Prostate Adenocarcinoma: TransCutaneous Hormones (PATCH) trial evaluating luteinising hormone-releasing hormone agonists versus transdermal oestradiol for androgen suppression in advanced prostate cancer

Duncan C. Gilbert*, Trinh Duong*, Howard G. Kynaston, Abdulla A. Alhasso, Fay H. Cafferty*, Stuart D. Rosen§, Subramanian Kanaga-Sundaram, Sanjay Dixit**, Marc Laniado††, Sanjeev Madaan‡‡, Gerald Collins§§, Alvan Pope¶¶, Andrew Welland*, Matthew Nankivell*, Richard Wassersug***, Mahesh K. B. Parmar*, Ruth E. Langleyand Paul D. Abel†††‡‡‡

 

*Medical Research Council Clinical Trials Unit at University College London, London, Cardiff School of Medicine, Cardiff University, Cardiff, The Beatson West of Scotland Cancer Centre, Glasgow, §National Heart and Lung Institute, Imperial College London, London, Mid-Yorkshire Hospitals NHS Trust, Pinder elds General Hospital, Wakeeld, **Scunthorpe General Hospital, North Lincolnshire and Goole NHS Trust, Scunthorpe, ††Frimley Health NHS Foundation Trust, Wexham Park Hospital, Slough, ‡‡Dartford and Gravesham NHS Trust, Darent Valley Hospital, Dartford, §§Stockport NHS Foundation Trust, Stepping Hill Hospital, Stockport, ¶¶The Hillingdon Hospitals NHS Foundation Trust, London, UK, ***University of British Columbia, Vancouver, BC, Canada, †††Imperial College Healthcare NHS Trust, and ‡‡‡Imperial College London, London, UK

 

Read the full article

Objectives

To compare quality-of-life (QoL) outcomes at 6 months between men with advanced prostate cancer receiving either transdermal oestradiol (tE2) or luteinising hormone-releasing hormone agonists (LHRHa) for androgen-deprivation therapy (ADT).

Patients and methods

Men with locally advanced or metastatic prostate cancer participating in an ongoing randomised, multicentre UK trial comparing tE2 versus LHRHa for ADT were enrolled into a QoL sub-study. tE2 was delivered via three or four transcutaneous patches containing oestradiol 100 μg/24 h. LHRHa was administered as per local practice. Patients completed questionnaires based on the European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core (EORTC QLQ-C30) with prostate-specific module QLQ PR25. The primary outcome measure was global QoL score at 6 months, compared between randomised arms.

aotw-may-4-fi

Results

In all, 727 men were enrolled between August 2007 and October 2015 (412 tE2, 315 LHRHa) with QoL questionnaires completed at both baseline and 6 months. Baseline clinical characteristics were similar between arms: median (interquartile range) age of 74 (68–79) years and PSA level of 44 (19–119) ng/mL, and 40% (294/727) had metastatic disease. At 6 months, patients on tE2 reported higher global QoL than those on LHRHa (mean difference +4.2, 95% confidence interval 1.2–7.1; P = 0.006), less fatigue, and improved physical function. Men in the tE2 arm were less likely to experience hot flushes (8% vs 46%), and report a lack of sexual interest (59% vs 74%) and sexual activity, but had higher rates of significant gynaecomastia (37% vs 5%). The higher incidence of hot flushes among LHRHa patients appear to account for both the reduced global QoL and increased fatigue in the LHRHa arm compared to the tE2 arm.

Conclusion

Patients receiving tE2 for ADT had better 6-month self-reported QoL outcomes compared to those on LHRHa, but increased likelihood of gynaecomastia. The ongoing trial will evaluate clinical efficacy and longer term QoL. These findings are also potentially relevant for short-term neoadjuvant ADT.

Read more articles of the week

Article of the Week: Prostatic urethral lift vs transurethral resection of the prostate

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.

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

Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study

Christian Gratzke*, Neil Barber, Mark J. Speakman, Richard Berges§Ulrich Wetterauer, Damien Greene**, Karl-Dietrich Sievert††, Christopher R. Chapple‡‡Jacob M. Patterson‡‡, Lasse Fahrenkrug§§, Martin Schoenthaler¶ and Jens Sonksen

 

§§*Department of Urology, Ludwig-Maximilians University, Munich, Germany, † Frimley Park Hospital NHS Foundation Trust, Surrey, UK, Department of Urology, Taunton and Somerset NHS Trust, Taunton, UK, §PAN Klinik Koln, Koln, Germany, Department of Urology, University Hospital Freiburg, Freiburg, Germany, **City Hospitals Sunderland, Sunderland, UK, ††University Clinic of Lubeck, Lubeck, Germany, ‡‡Shefeld Teaching Hospitals NHS Foundation Trust, Shefeld, UK, and §§Department of Urology, Herlev Hospital, Herlev, Denmark

 

Read the full article

Abstract

Objectives

To compare prostatic urethral lift (PUL) with transurethral resection of the prostate (TURP) with regard to symptoms, recovery experience, sexual function, continence, safety, quality of life, sleep and overall patient perception.

Patients and Methods

A total of 80 patients with lower urinary tract symptoms attributable to benign prostatic hyperplasia (BPH) were enrolled in a prospective, randomized, controlled, non-blinded study conducted at 10 European centres. The BPH6 responder endpoint assessed symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation and safety. Additional evaluations of patient perspective, quality of life and sleep were prospectively collected, analysed and presented for the first time.

aotw-may-3-results

Results

Significant improvements in International Prostate Symptom Score (IPSS), IPSS quality of life (QoL), BPH Impact Index (BPHII), and maximum urinary flow rate (Qmax) were observed in both arms throughout the 2-year follow up. Change in IPSS and Qmax in the TURP arm were superior to the PUL arm. Improvements in IPSS QoL and BPHII score were not statistically different between the study arms. PUL resulted in superior quality of recovery, ejaculatory function preservation and performance on the composite BPH6 index. Ejaculatory function bother scores did not change significantly in either treatment arm. TURP significantly compromised continence function at 2 weeks and 3 months. Only PUL resulted in statistically significant improvement in sleep.

Conclusion

PUL was compared to TURP in a randomised, controlled study which further characterized both modalities so that care providers and patients can better understand the net benefit when selecting a treatment option.

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Editorial: The BPH6 study raises the bar on how we should conduct BPH surgical trials

We have all done it. We’ve all shaken our heads with bemusement when men have severe symptoms, as would be defined by the IPSS, yet their response to the quality-of-life question would either be ‘delighted’ or ‘satisfied’. Likewise, we may see men who have objective multiple-fold improvement in their urinary flow rates after a BPH surgical procedure but are more unhappy about their urinary function than they were with their preoperative state. Such mismatches in clinician and patient expectation are not uncommon in clinical practice and are likely, in part, to be a reflection of what measurements clinicians and patients consider to be of importance.

The BPH6 study has challenged the traditional way in which the success of a surgical treatment has been assessed [1]. When prostatic urethral lift (PUL) was compared with TURP in the setting of a randomized controlled trial, there was clearly superior performance of the former as highlighted by a patient-centred outcome metric referred to as the BPH6. It could be argued on the one hand that the combined metric games the outcome in favour of PUL, given that known shortfalls in TURP outcomes, such as recovery, sexual dysfunction and morbidity, could not see it fairly compete with a minimally invasive surgical treatment, but, on the other hand, perhaps the BPH6 metric is just measuring what matters to our patients. The BPH6 is made up of variables that are not in any way new and have all either been established or validated ways of measuring outcomes. A valid criticism, however, is that the combined BPH6 metric is yet to be validated.

Gratze et al. [2] report the 2-year results of the BPH6 study, in a paper that is a great deal more than just a progress report. It represents the most comprehensive patient-centred outcome and quality-of-life assessment ever performed on BPH surgical procedures. Their study also introduces several patient-centred outcome measures that were not reported in the 1-year publication. Additional to the now already well-described BPH6 variables, the study includes the Patient Global Impression of Improvement (PGI-I), the Short-Form Health Survey (SF-12) with its derivative SF-6D utility score, the minimal clinical important difference (MCID) and the Jenkins Sleep Questionnaire.

The PGI-I is perhaps the true test as to what a patient thinks about the effectiveness of a surgical procedure. There is no ambiguity about a response to a direct question as to whether a patient perceives a treatment to have improved or worsened their condition. Whilst the origins of the PGI-I are in the non-urological literature, it has recently been making its way into BPH clinical studies [3, 4]. This should be encouraged and we should indeed dare to ask our patients whether they consider our treatment has lead to improvement or otherwise.

The MCID has been used extensively in the medical literature since its introduction in 1989 [5]. The BPH6 study is the first clinical trial on BPH surgical treatment to use this metric. The MCID is exactly as the term is defined, and is assessed across a range of measures in the paper by Gratze et al. in the context of quality of life. A literature search will reveal that urologists have been very late to the party, but this study will probably have a role-modelling effect with regard to the future use of the MCID in health-related quality of life assessments in BPH studies.

The BPH6 study raises the bar for how we should measure the full impact of the surgical treatment of BPH. There has never been a clinical study that has explored patient-centred outcome measures and quality of life after surgical treatment of BPH to an extent that is even remotely close to that reported here. Whether the combined BPH6 metric becomes popularized or not is less important than the fact that future clinical trials will undoubtedly see an adoption of patient-measured outcomes. Such measures could play an increasingly important role in the decision process for health funders to support a new or existing treatment as well as assist patients in understanding the trade-off between the negative and positive impacts of treatment. We can expect to see plenty of future work that will attempt to verify these assertions.

Read the full article

How to Cite

Woo, H. H. (2017), The BPH6 study raises the bar on how we should conduct BPH surgical trials. BJU International, 119: 654–655. doi: 10.1111/bju.13815

Henry H. Woo
Sydney Adventist Hospital Clinical School, University of Sydney, Sydney, NSW, Australia

 

References

 

 

Article of the Week: Evaluation of the ATOMS

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.

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

Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study

Alexander Friedl*, Sandra Muhlstadt, Roman Zachoval, Alessandro Giammo§Danijel Kivaranovic, Maximilian Rom**, Paolo Fornara† and Clemens Brossner*
*Department of Urology, Hospital Gottlicher Heiland, Vienna, Austria, Klinik and Poliklinik of Urology and Kidney Transplantation, University Hospital, Martin-Luther-University, Halle-Wittenberg, Halle/Saale, Germany, Thomayer Hospital, Department of Urology and 1st and 3rd Medical Faculty, Charles University, Prague, Czech Republic, §Neuro-Urology Department, CTO-Spinal Unit Hospital, Turin, Italy, Center for Medical Statistics, Informatics, and Intelligent Systems, and **Department of Urology, Medical University Vienna, Vienna, Austria
Read the full article

How to Cite

Friedl, A., Mühlstädt, S., Zachoval, R., Giammò, A., Kivaranovic, D., Rom, M., Fornara, P. and Brössner, C. (2017), Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study. BJU International, 119: 785–792. doi: 10.1111/bju.13684

Objective

To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS®, Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting.

Patients and Methods

In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (<10 mL/day and 0–1 pad/day), device durability, treatment failure, and device complications were recorded. Nonparametric tests were used for statistical analyses.

may-aotw-2-results

Results

After a median (interquartile range [IQR]) follow-up of 31 (10–54) months and a median (IQR) of 3 (2–4) adjustments, the overall success rate was 90% (258 men) and the dry rate was 64% (184). Daily pad test and pad use decreased from a median of 400 mL/day and 4 pads/day to a median of 18 mL/day and 1 pad/day (both P < 0.001), concomitantly QoL ratings significantly improved and changed to a high level of satisfaction (PGI-I 4 to 2, ICIQ-SF 17 to 5; both P < 0.001). The UI results at 12 months were comparable to those at final follow-up. Chronic pain and intraoperative complications did not occur. Most of the postoperative complications were Clavien–Dindo grade I–III (no grade IV or V). At present, 231 (80%) of all the ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P < 0.001) were prognostic factors for beneficial treatment outcome.

Conclusion

The ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy.

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Editorial: The ATOMS… Is it really all so easy?

The adjustable transobturator male system (ATOMS® Agency for Medical Innovations A.M.I., Feldkirch, Austria) is an interesting device (the design is evocative of the historical Kaufmann sling) that is now incorporated into the wide spectrum of post-prostatectomy incontinence treatments, and which confirms the real existing pathology despite the introduction of optimised robot-assisted prostate surgery. An interesting article in the present issue of BJUI describes the long-term outcome of the ATOMS device [1].

But there are some considerations that I would like to raise about this device. Only the first generation of ATOMS (inguinal port, IP) has long-term follow-up data and 15% of implanted devices have been explanted within 6–33 months [2]. So, I think we have to be prudent and wait for further long-term results for the third-generation silicone-covered scrotal port (SSP) system, as it has only 2–7 months of previously published outcome data.

As the explantation rates of all other silicone devices are still high, between 12% and 35% in the mid- to long-term, why should we not expect this for the ATOMS SSP third generation? All devices (sphincters, Argus, Reemex etc.) have an explantation risk and the causes are, in most cases infections and erosions, i.e. still trophic problems.

As stated, the explant rate of silicone devices is still high, but the removal of silicone parts is relatively easy because of the ‘coating’ by a collagenous capsule. On the other hand, male slings (mesh) are really rarely infected and require explantation, but if this happens a complete removal of the transobturator tape (TOT) male mesh sling is needed, which is still relatively challenging surgery and incapacitating for the patient, especially if the mesh has become ingrown.

Another point in the study of Friedl et al. [1] is that titanium intolerance is described as one of the main causes of device explantation (41%). We have to consider the broad use of titanium-covered meshes or titanium artificial hips, as in the literature prosthesis explantation caused by titanium intolerance have not been reported at such high percentages. It thus seems unlikely that titanium intolerance should be the problem rather than trophic or mechanical factors leading to erosion (41% of ATOMS explants in long-term follow-up [1]).

Lastly, we know that patients with minimal and moderate incontinence can be treated successfully by a simple tissue-fixed TOT sling. Patients with more intrinsic sphincter deficiency, with repeated anastomotic incisions or resections need a more compressive device, and compression needs adjustability over time, a field for devices such as Argus and Reemex for example. Also at night time, patients with incontinence (real and severe intrinsic sphincter deficiency) need an artificial sphincter for continence and good unobstructed voiding (on/off). So which group of patients should be targeted for this combination between a hydraulic-filled balloon, adjustable subcutaneous port and TOT sling, as 60–70% of patients with mild-to-moderate incontinence are dry using the sling alone [3]. Should it be the first choice for all non-irradiated patients? or for those that have TOT failure? Or artificial sphincter failure? Or intrinsic sphincter deficiency? Therefore, what we need to clarify is the real indications for this combined tri-component device (silicone port, silicone balloon and TOT mesh). And we must also not forget that there could be atrophy of the membranous urethra due to the bulking effect of the silicone balloon. This is another point that has to be considered.

In the treatment of male incontinence we must focus not only on the effectiveness but also on the safety of the device used. This is particularly important considering the warning issued by the USA Food and Drug Administration (FDA) for female mesh slings.

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How to Cite

Gozzi, C. (2017), Considerations about the adjustable transobturator male system (ATOMS®) device… is it really all so easy?. BJU International, 119: 655–656. doi: 10.1111/bju.13830

 

Christian Gozzi
Department of Urology, Marienklinik, Bolzano, Italy

 

References

 

 

Article of the Month: Partin Tables in the Contemporary Era

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.

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.

Prediction of pathological stage based on clinical stage, serum prostate-specific antigen, and biopsy Gleason score: Partin Tables in the contemporary era

Jeffrey J. Tosoian, Meera Chappidi, Zhaoyong Feng, Elizabeth B. Humphreys, Misop HanChristian P. Pavlovich, Jonathan I. Epstein, Alan W. Partin and Bruce J. Trock

The James Buchanan Brady Urological Institute and Department of Urology at the Johns Hopkins University School of Medicine, Baltimore, MD, USA

 

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How to Cite this Article

Tosoian, J. J., Chappidi, M., Feng, Z., Humphreys, E. B., Han, M., Pavlovich, C. P., Epstein, J. I., Partin, A. W. and Trock, B. J. (2017), Prediction of pathological stage based on clinical stage, serum prostate-specific antigen, and biopsy Gleason score: Partin Tables in the contemporary era. BJU International, 119: 676–683. doi: 10.1111/bju.13573

Abstract

Objective

To update the Partin Tables for prediction of pathological stage in the contemporary setting and examine trends in patients treated with radical prostatectomy (RP) over the past three decades.

Patients and Methods

From January 2010 to October 2015, 4459 men meeting inclusion criteria underwent RP and pelvic lymphadenectomy for histologically confirmed prostate cancer at the Johns Hopkins Hospital. Preoperative clinical stage, serum prostate-specific antigen (PSA) level, and biopsy Gleason score (i.e. prognostic Grade Group) were used in a polychotomous logistic regression model to predict the probability of pathological outcomes categorised as: organ-confined (OC), extraprostatic extension (EPE), seminal vesicle involvement (SV+), or lymph node involvement (LN+). Preoperative characteristics and pathological findings in men treated with RP since 1983 were collected and clinical-pathological trends were described.

aotm-may-2017

Results

The median (range) age at surgery was 60 (34–77) years and the median (range) PSA level was 4.9 (0.1–125.0) ng/mL. The observed probabilities of pathological outcomes were: OC disease in 74%, EPE in 20%, SV+ in 4%, and LN+ in 2%. The probability of EPE increased substantially when biopsy Gleason score increased from 6 (Grade Group 1, GG1) to 3 + 4 (GG2), with smaller increases for higher grades. The probability of LN+ was substantially higher for biopsy Gleason score 9–10 (GG5) as compared to lower Gleason scores. Area under the receiver operating characteristic curves for binary logistic models predicting EPE, SV+, and LN+ vs OC were 0.724, 0.856, and 0.918, respectively. The proportion of men treated with biopsy Gleason score ≤6 cancer (GG1) was 47%, representing a substantial decrease from 63% in the previous cohort and 77% in 2000–2005. The proportion of men with OC cancer has remained similar during that time, equalling 73–74% overall. The proportions of men with SV+ (4.1% from 3.4%) and LN+ (2.3% from 1.4%) increased relative to the preceding era for the first time since the Partin Tables were introduced in 1993.

Conclusions

The Partin Tables remain a straightforward and accurate approach for projecting pathological outcomes based on readily available clinical data. Acknowledging these data are derived from a tertiary care referral centre, the proportion of men with OC disease has remained stable since 2000, despite a substantial decline in the proportion of men with biopsy Gleason score 6 (GG1). This is consistent with the notion that many men with Gleason score 6 (GG1) disease were over treated in previous eras.

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