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Article of the week: A national study of artificial urinary sphincter and male sling implantation after radical prostatectomy in England

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 this post, there is an editorial written by a prominent member of the urological community. Please use the comment buttons below to join the conversation.

If you only have time to read one article this week, we recommend this one. 

A national study of artificial urinary sphincter and male sling implantation after radical prostatectomy in England

Amandeep Dosanjh*, Simon Baldwin*, Jemma Mytton*, Dominic King, Nigel Trudgill, Mohammed Belal and Prashant Patel

*Department of Health Informatics, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK , Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK and Department of Urology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

Abstract

Objectives

To consider the provision of post‐radical prostatectomy (RP) continence surgery in England.

Materials and Methods

Patients with an Office of Population Census and Surveys Classification of Interventions and Procedures, version 4 code for an artificial urinary sphincter (AUS) or male sling between 1 January 2010 and 31 March 2018 were searched for within the Hospital Episode Statistics (HES) dataset. Those without previous RP were excluded. Multivariable logistic regressions for repeat AUS and sling procedures were built in stata. Further descriptive analysis of provision of procedures was performed.

Fig.3. Funnel plot displaying the standardized redo/removal rate for centres implanting artificial urinary sphincter, coloured by provider volume tertile. The inner control lines are set at 2 sd from the mean and outer at 3.

Results

A total of 1414 patients had received index AUS, 10.3% of whom had undergone prior radiotherapy; their median follow‐up was 3.55 years. The sling cohort contained 816 patients; 6.7% of these had received prior radiotherapy and the median follow‐up was 3.23 years. Whilst the number of AUS devices implanted had increased each year, male slings peaked in 2014/2015. AUS redo/removal was performed in 11.2% of patients. Patients in low‐volume centres were more likely to require redo/removal (odds ratio [OR] 2.23 95% confidence interval [CI] 1.02–4.86; P = 0.045). A total of 12.0% patients with a sling progressed to AUS implantation and 1.3% had a second sling. Patients with previous radiotherapy were more likely to require a second operation (OR 2.03 95% CI 1.01–4.06; P = 0.046). Emergency re‐admissions within 30 days of index operation were 3.9% and 3.6% fewer in high‐volume centres, for AUS and slings respectively. The median time to initial continence surgery from RP was 2.8 years. Increased time from RP conferred no reduced risk of redo surgery for either procedure.

Conclusion

There is a volume effect for outcomes of AUS procedures, suggesting that they should only be performed in high‐volume centres. Given the known impact of incontinence on quality of life, patients should be referred sooner for post‐prostatectomy continence surgery.

Editorial: A contemporary view on the use of slings and artificial urinary sphincters for the treatment of post‐prostatectomy incontinence in England

Post‐prostatectomy urinary incontinence (UI) is a well‐recognised consequence of radical prostatectomy carried out as treatment for organ‐confined prostate cancer. This interesting article [1] reviews the in-practice surgical management of post‐prostatectomy UI in England over an 8‐year period, using the Hospital Episodes Statistics (HES) database.

In total, 1414 patients had an artificial urinary sphincter (AUS) implanted, with a median follow‐up of 3.55 years. In contrast, 816 patients were treated with a male sling, with a median follow‐up of 3.23 years. Post‐prostatectomy AUS implantation was performed in 49 centres and male sling surgery in 48 centres. It is not clear whether the same centres were involved in implanting both devices; it is however of note that for AUS implantation, 34.7% of the centres performed fewer than six post‐prostatectomy AUS implantations over the 8‐year period and 18.4% performed >50 in the same period. Both re‐do and removal surgery of AUS had some association with low‐volume providers; 7.7% of patients received a second AUS and 0.8% had undergone the procedures three or more times. A total of 12.5% of patients had an AUS re‐do or removal; 0.6% of these were within 6 weeks of the index procedure. Prior sling surgery did not predict an increased likelihood of re‐do or removal. Similarly, 33.3% of centres performed less than six post‐prostatectomy sling surgeries over the 8‐year period and only 4.3% performed >50 procedures. There was no association of centre volume with the likelihood of sling revision.

With reference to the potential impact of radiotherapy (RT), in two centres there was a 19.3% incidence of patients with prior RT compared to 9.4% for the other provider groups. Prior RT was associated with a two‐fold increase risk of sling revision. The authors conclude that previous RT did not confer a higher risk of re‐do or removal of AUS.

As with any real‐life practice study, there are potential limitations to interpretation of the data.

  • The two surgical approaches have often been used for different levels of UI, where clearly the more severe forms of UI have tended to be considered as an indication for the AUS.
  • It is not possible to identify the severity of the preoperative UI.
  • There is no standard code for the removal of a male sling, which limits the ability to comment accurately on this. Nevertheless, as a proxy, a failed sling procedure would usually be an indication for using an AUS rather than another sling.

The most important take home message from this article is the importance of undergoing post‐prostatectomy UI surgery in a high‐volume centre. A prospective database should be established to document the indications for, as well as outcomes, following both AUS and sling surgery in real‐life clinical practice. Certainly, this is likely to become mandatory under European Commission law and it would be of importance for this to be likewise implemented in the UK in the future.

by Christopher Chapple

Reference

  1. Dosanjh ABaldwin SMytton J et al. A national study of artificial urinary sphincter and male sling implantation after radical prostatectomy in England. BJU Int 2020125467‐ 75.

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

 

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

 

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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