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Editorial: Guidelines on urinary incontinence: it is time to join forces!

Urinary incontinence is not life‐threatening and does not kill patients, but it is highly prevalent affecting millions of people worldwide, it significantly impairs quality of life, and the related health‐care costs are enormous. Thus, guidelines are crucial for helping us to achieve an optimal management of our patients with urinary incontinence.

In this month’s issue of the BJUI, Sussman et al. present a Guideline of Guidelines on urinary incontinence in women. They reviewed the guidelines of the American College of Obstetrics and Gynecology (ACOG) / American Urogynecologic Society (AUGS), American Urological Association (AUA) / Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), European Association of Urology (EAU), International Consultation on Incontinence (ICI), and National Institute for Health and Care Excellence (NICE). The recommendations of the different guidelines were similar for the initial evaluation and conservative therapies but differed considerably in some points of invasive management. In brief, the most essential issues are the following: Basic work‐up includes detailed history taking and specifying the type of urinary incontinence, urodynamics is performed when it changes management and in cases of recurrent urinary incontinence after interventions, treatment follows a stepwise approach starting with conservative therapy and moving to invasive options as appropriate, and treatment of women with mixed urinary incontinence is focused on the predominant symptom.

Although the management of urinary incontinence is well defined and excellently summarised by Sussman et al., treatment often remains demanding in daily clinical practice due to insufficient effectiveness or relevant side effects, so that new therapeutic options are urgently needed. Vibegron is a novel β3‐adrenoreceptor agonist, and Yoshida et al. present in the current issue of the BJUI promising findings with this drug for treating severe urgency urinary incontinence related to overactive bladder. In a post hoc analysis of a randomised, placebo‐controlled, double‐blind, comparative phase 3 study, vibegron significantly reduced the number of urgency urinary incontinence episodes and significantly increased voided volume per micturition with a response rate exceeding 50% [Yoshida et al]. These results are encouraging and warrant further randomised controlled trials, but also vibegron seems not to be a miracle agent showing effects in the range of mirabegron or antimuscarinics. However, there is some light at the end of the tunnel: Closed‐loop optogenetic neuromodulation systems targeting specific neurons to control urinary tract function might completely revolutionise the field, although there are still relevant hurdles to overcome.

Guidelines should result from a rigorous and transparent process informed by the best available up‐to‐date evidence and safeguarded against biases and conflict of interests. This is a major challenge, and from a bird’s eye view, it is hard to comprehend that several guidelines on the same topic exist and it is even more difficult to understand that the recommendations of these guidelines are not congruent and sometimes even contradictory. For instance, in the case of a pelvic organ prolapse repair in a continent woman, the ACOG / AUGS, AUA / SUFU, and EAU guidelines discuss prophylactic anti‐incontinence surgery as an option, whereas ICI and NICE guidelines explicitly recommend against it. The redundancy is enormous, but societies and organisations still create their own guidelines – an unnecessary waste of resources. In recent times, the coronavirus pandemic has rapidly changed our life and paralysed our usual activities, we have to stand together, it is definitively time to join forces! The relevant societies and organisations should consult each other and coordinate their efforts. Together we are strong, let’s move forward to joint guidelines!

Article of the Month – Guidelines of the Guidelines: Urinary Incontinence in Women

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 editorial prepared by a prominent member of the urological community and a video by the authors; 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 month, we recommend this one. 

Guidelines of the Guidelines: Urinary Incontinence in Women

Rachael D. Sussman*, Raveen Syan and Benjamin M. Brucker
*Department of Urology, MedStar Georgetown University Hospital, Washington, DC, Department of Urology, Stanford School of Medicine, Stanford, CA, and Department of Urology, New York University Medical Center, New York, NY, USA

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Introduction

Urinary incontinence (UI) is a common disease, with prevalence rates as high as 44–57% in middle‐aged and post‐menopausal women. Those with UI may experience physical, functional, and psychological limitations and diminished quality of life (QoL) at home and at work. The financial burden of UI care is significant, with an estimated direct cost of $19.5 billion (American dollars) in the USA alone.

UI can be classified into a number of different categories, with stress UI (SUI) and urgency UI (UUI) being the most common. Many professional organisations have created guidelines to help clinicians navigate the diagnosis and evaluation of UI, as well as the treatments including conservative, pharmacological, and surgical. The methodologies upon which most guidelines are based are similar, starting with systematic reviews and grading of available literature. Organisations then make recommendations with different definitions and strengths. Guidelines are not exhaustive, but rather serve as a practical review of evidence‐based management of ‘index patients’.

The present ‘Guideline of guidelines,’ updated from a 2016 publication, reviews various international guidelines that have been updated at different time intervals and provides an updated summary of the important similarities and differences on the management of UI in women.

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Video – Guidelines of the Guidelines: Urinary Incontinence in Women

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Article of the Week: TVT for treatment of pure urodynamic SUI

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.

Tension‐free vaginal tape for treatment of pure urodynamic stress urinary incontinence: efficacy and adverse effects at 17‐year follow‐up

Andrea Braga* , Giorgio Caccia*, Paola Sorice, Simona CantaluppiAnna Chiara Coluccia, Maria Carmela Di Dedda, Luca Regusci*, Fabio GhezziStefano Uccella§ and Maurizio Serati

 

*Department of Obstetrics and Gynecology, EOC Beata Vergine Hospital, Mendrisio, Switzerland, Department of Obstetrics and Gynecology, G. Fornaroli Hospital, Magenta, Italy, Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy, and §Department of Woman and Child Health, Fondazione Policlinico Gemelli, Rome, Italy

 

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Abstract

Objective

To assess the efficacy and safety of retropubic tension‐free vaginal tape (TVT) 17 years after implantation for the treatment of female pure stress urinary incontinence (SUI).

Patients and Methods

A prospective study was conducted in two urogynaecological units in two countries. All consecutive women with urodynamically proven pure SUI treated by TVT were included. Patients with mixed incontinence and/or anatomical evidence of pelvic organ prolapse were excluded. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire–Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow‐up. Univariable analysis was performed to investigate outcomes.

Results

A total of 52 women underwent TVT implantation. At 17‐year follow‐up, 46 women (88.4%) were available for the evaluation. We did not find any significant change in surgical outcomes during this time. At 17 years after surgery, 41 of 46 women (89.1%) declared themselves cured (P = 0.98). Similarly, at 17‐year evaluation, 42 of 46 women (91.4%) were objectively cured. No significant deterioration in objective cure rates was observed over time (P for trend 0.50). The univariate analysis did not find any risk factor statistically associated with the recurrence of SUI. Of the 46 women, 15 (32.6%) reported the onset of de novo overactive bladder at 17‐year follow‐up. No other late complications were reported.

Conclusions

The 17‐year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI.

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Editorial: Can we still recommend tension‐free vaginal tape for long‐term safety and efficacy?

Traditional retropubic tension‐free vaginal tape (TVT) has been in widespread use for over 20 years. It has been estimated that 10 million women worldwide have received mid‐urethral tapes, and that at least half of these have been traditional retropubic TVTs. So, why have TVTs suddenly fallen into disrepute? Surely, so many women and their healthcare advisors can’t all be wrong? With this in mind, Braga et al. [1] are to be congratulated on their study in this issue of BJUI, in which they evaluate the efficacy and adverse effects of TVT for treatment of pure urodynamic stress urinary incontinence (SUI), with a 17‐year follow‐up.

Women’s reproductive health has been very well established compared to decades ago. Nowadays, women have options and opportunity to take care of themselves. After pregnancy, some women opt to tighten to vaginal walls. You can read more on that topic on vtightensafely.com. Reasons may vary for doing so, but the point is we’ve come a long way.

Whilst there have been other publications detailing relatively long‐term follow‐up of this procedure, as referenced in Braga et al. in their paper, the only study reported to date with a 17‐year follow‐up is that by Nillson et al. [2], who are from the three centres in Scandinavia where the mid‐urethral retropubic tape procedures were originally developed and undertaken. In the present study from Italy and Switzerland, however, Braga et al. have managed to follow up 46 out of 52 (88.4%) women who had a traditional TVT inserted between 1998 and 2000 [1]. The remaining patients were lost to follow‐up or had died in the intervening period. The patients were assessed using both subjective and objective outcome measures. At 17 years, 41 out of 46 patients (89.1%) were cured subjectively and 42 out of 46 (91.3%) were cured objectively on a stress test. The only long‐term adverse outcome was de novo overactive bladder (OAB) symptoms, which were reported by 15 out of 46 (32.6%) women at 17‐year follow‐up. This is not surprising, as it is well known that the prevalence of OAB increases with age [3], and obviously these women were significantly older when assessed at 17‐year follow‐up than when their TVTs were inserted. Unfortunately, despite the use of quality‐of‐life outcome measures (Patient Global Impression of Improvement and patient satisfaction scores), the authors have not reported the overall change in quality of life. This could be important when considering cure of SUI at the possible expense of developing OAB symptoms in later life. Most importantly, there were no reported TVT‐associated complications requiring release or resection of the TVT, nor were there any erosions into the vagina, bladder or urethra.

Although the use of all mid‐urethral tapes for urinary incontinence and meshes for pelvic organ prolapse was suspended by the Scottish Health Minister in 2014, because of concerns regarding a perceived high complication rate, brought about by a group of vocal campaigners and fuelled by the press, the final report published in 2017 recommended that women choosing surgery for SUI should be offered all available options including mesh and non‐mesh procedures [4]. Similarly, the final NHS England mesh report in 2017 [5] supported the use of retropubic mid‐urethral tapes rather than the trans‐obturator route, and the European (SCENIHR) Report [6] concluded that mesh for SUI is safe and should continue to be offered as a choice for women seeking surgery for their SUI.

Obviously, a wide range of options is available for the management of SUI, and conservative measures including pelvic floor muscle training should be offered first. For those women who do not desire a surgical solution, duloxetine is available and can be very effective when adequately tolerated. For those women who wish to undergo surgery, however, the main choices are a bulking agent, mid‐urethral tape, colposuspension or an autologous fascial sling. From all the reports and published literature to date the TVT would appear to be as, if not more, effective than all other procedures without having a higher complication rate. The data in the present paper by Braga et al. [1] should reassure healthcare providers that TVT continues to be a safe and effective surgical strategy for the management of SUI in women.

 

Linda Cardozo
Department of Urogynaecology, Kings College HospitalLondon, UK

 

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References
  • Braga A, Caccia G, Sorice P, et al. Tension‐free vaginal tape for treatment of pure urodynamic stress urinary incontinence: efficacy and adverse effects at 17‐year follow‐upBJU 2018122: 113–7

 

  • Nilsson CG, Palva K, Aarnio R, et al. Seventeen years’ follow‐up of the tension free vaginal tape procedure for female stress urinary incontinenceInt Urogynaecol J. 201324: 1265–69

 

  • Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population based prevalence studyBJU Int 200188: 807

 

  • 4 The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women: Final Report March 2017

 

 

  • European (SCENIHR) Report Opinion on the Safety of Surgical Meshes Used in Urogynecological Surgery. December 2015

 

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Article of the week: The changing face of urinary continence surgery in England

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

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

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from John Withington and Arun Sahai discussing their paper.

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

The changing face of urinary continence surgery in England: a perspective from the Hospital Episode Statistics database

John Withington, Sadaf Hirji and Arun Sahai

Guy’s and St Thomas’ NHS Hospitals’Trust, King’s College London, London, UK

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OBJECTIVE

To quantify changes in surgical practice in the treatment of stress urinary incontinence (SUI), urge urinary incontinence (UUI) and post-prostatectomy stress incontinence (PPI) in England, using the Hospital Episode Statistics (HES) database.

PATIENTS AND METHODS

We used public domain information from the HES database, an administrative dataset recording all hospital admissions and procedures in England, to find evidence of change in the use of various surgical procedures for urinary incontinence from 2000 to 2012.

RESULTS

For the treatment of SUI, a general increase in the use of synthetic mid-urethral tapes, such as tension-free vaginal tape (TVTO) and transobturator tape (TOT), was observed, while there was a significant decrease in colposuspension procedures over the same period. The number of procedures to remove TVT and TOT has also increased in recent years. In the treatment of overactive bladder and UUI, there has been a significant increase in the use of botulinum toxin A and neuromodulation in recent years. This coincided with a steady decline in the recorded use of clam ileocystoplasty. A steady increase was observed in the insertion of artificial urinary sphincter (AUS) devices in men, related to PPI.

CONCLUSIONS

Mid-urethral synthetic tapes now represent the mainstream treatment of SUI in women, but tape-related complications have led to an increase in procedures to remove these devices. The uptake of botulinum toxin A and sacral neuromodulation has led to fewer clam ileocystoplasty procedures being performed. The steady increase in insertions of AUSs in men is unsurprising and reflects the widespread uptake of radical prostatectomy in recent years. There are limitations to results sourced from the HES database, with potential inaccuracy of coding; however, these data support the trends observed by experts in this field.

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Editorial: Routine data expose a need for change

Withington et al. [1], in their analysis of changes in stress urinary incontinence (SUI) surgery in England, have tapped in to a rich seam of information which, as well as holding the promise of much more, also highlights a need for changed thinking about services and training. They have produced an excellent review of the use of Hospital Episode Statistics (HES) data to establish a pattern of changing surgical practice for the treatment of urinary incontinence in England. They rightly point out the great potential of using patient-specific linked data to explore other relationships between predictors and outcome. Widespread use of powerful data of this sort could, theoretically at least, help to answer research questions, as well as to plan service design and resource allocation.

The use of routine data by the NHS is a hot topic in the UK at present. An England wide database, Care.data, has been developed that plans to link anonymised routine data, automatically drawn from community care, hospital statistics, public health and social care databases. Whilst debate rages about the confidentiality issues, and conspiracy theories abound, some strident voices promote a vision of how such a databank will be used to address big health questions and to identify relationships between social conditions, healthcare and outcomes, which have not previously been possible. Similar projects exist in Wales and Scotland enjoying the acronyms of SAIL (Secure Anonymised Information Linkage) and SPIRE (The Scottish Primary Care Information Resource), and Northern Ireland also has plans in progress. These systems do differ subtly in detail but not in aspiration [2].

The authors’ findings confirm that lesser invasive procedures now dominate the treatment of SUI in women, and that the use of Botulinum toxin A for treating refractory urgency incontinence, despite the absence until recently of a license for its use, has become commonplace. Whilst demand for SUI surgery may have levelled off, following something of a surge in recent years, the demand for Botulinum toxin A treatment inevitably increases as patients become locked in to long-term retreatment programmes. With these numbers it should be possible for a hospital serving a population of, say, 250 000 to perform at least 40–50 of each procedure per annum. This is probably enough to sustain a routine service, consistent with recommendations from the National Institute for Health and Clinical Excellence (NICE), which described how surgeons should seek to maintain expertise through, amongst other things, having an adequate caseload [3].

Sacral neuromodulation (SNS), artificial sphincter, colposuspension, tape removal and augmentation cystoplasty are procedures that occupy the complex end of a range of surgical options for incontinence. These are patients who have often failed other treatments, defy easy categorisation, and are performed in relatively small numbers. SNS has not been adopted in the UK, as widely as might have been anticipated following NICE guidance in 2006, which strongly recommended its implementation – perhaps because of local difficulties in commissioning a procedure with such high capital costs. The low figures for all these procedures strengthen the argument to focus complex work into expert centres, where adequate numbers can be maintained and the next generation of specialists can be effectively trained.

Those who commission or plan service delivery, and those who design training programmes, need to take heed of this evidence. The nature of female and urodynamic urology has changed over recent years, now being characterised by 95% very routine procedures and 5% complex difficult cases. But if we centralise the 5% of complex work and leave those working in more peripheral hospitals able to offer only mid-urethral slings and Botulinum toxin A, then we have to reconsider the basis of specialist training. There is no point training a person to high levels of competence in complex procedures that they will never use in senior practice. The UK Continence Society is currently developing a set of minimum standards for service delivery and training, which will take this information into account.

The evidence presented by Withington et al. [1] is specific to England and it remains unclear how much these trends can be extrapolated to the UK nations with devolved healthcare, or indeed to other countries. However, Withington et al. [1] must be congratulated for highlighting both the power of routine data in clinical research, and specifically for identifying the dramatic changes in surgical practice of incontinence, which require an adaptive response from both the NHS and our specialist organisations.

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Malcolm Lucas
Department of Urology, Morriston Hospital, Swansea, UK

References

  1. Withington J, Hirji S, Sahai A. The changing face of urinary continence surgery in England: a perspective from the hospital episode statistics database. BJU Int 2014; 114: 268–277
  2. National Institute for Health and Clinical Excellence. September 2013. Urinary incontinence: the management of urinary incontinence in women. Clinical guidelines CG171. Available at: https://guidance.nice.org.uk/CG171. Accessed April 2014

 

Video: Urinary continence surgery in England

The changing face of urinary continence surgery in England: a perspective from the Hospital Episode Statistics database

John Withington, Sadaf Hirji and Arun Sahai

Guy’s and St Thomas’ NHS Hospitals’Trust, King’s College London, London, UK

Read the full article

OBJECTIVE

To quantify changes in surgical practice in the treatment of stress urinary incontinence (SUI), urge urinary incontinence (UUI) and post-prostatectomy stress incontinence (PPI) in England, using the Hospital Episode Statistics (HES) database.

PATIENTS AND METHODS

We used public domain information from the HES database, an administrative dataset recording all hospital admissions and procedures in England, to find evidence of change in the use of various surgical procedures for urinary incontinence from 2000 to 2012.

RESULTS

For the treatment of SUI, a general increase in the use of synthetic mid-urethral tapes, such as tension-free vaginal tape (TVTO) and transobturator tape (TOT), was observed, while there was a significant decrease in colposuspension procedures over the same period. The number of procedures to remove TVT and TOT has also increased in recent years. In the treatment of overactive bladder and UUI, there has been a significant increase in the use of botulinum toxin A and neuromodulation in recent years. This coincided with a steady decline in the recorded use of clam ileocystoplasty. A steady increase was observed in the insertion of artificial urinary sphincter (AUS) devices in men, related to PPI.

CONCLUSIONS

Mid-urethral synthetic tapes now represent the mainstream treatment of SUI in women, but tape-related complications have led to an increase in procedures to remove these devices. The uptake of botulinum toxin A and sacral neuromodulation has led to fewer clam ileocystoplasty procedures being performed. The steady increase in insertions of AUSs in men is unsurprising and reflects the widespread uptake of radical prostatectomy in recent years. There are limitations to results sourced from the HES database, with potential inaccuracy of coding; however, these data support the trends observed by experts in this field.

Read more articles of the week

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