Marcus Drake

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Urodynamics is acceptable and well-tolerated but best practice is not always provided: lessons from male patients interviewed during the UPSTREAM trial

November 15, 2018/by Lucy E. Selman

In a recently published qualitative study, we found that urodynamic testing was acceptable to men with lower urinary tract symptoms (LUTS), despite some reporting apprehension, discomfort or embarrassment and, at times, inadequate provision of information. Men’s experiences of urodynamics highlight ways in which clinical practice can be improved, including better communication about what to expect during and after the test, minimising embarrassment by ensuring privacy, and timely discussion of test results in sufficient detail.

Ninety percent of men aged 50‐80 live with at least one LUTS, which can negatively impact quality of life. LUTS prevalence and severity increase with age, and with demographic aging the management of LUTS is an increasing priority. Urodynamics with invasive multichannel cystometry is widely used when medications haven’t successfully relieved symptoms and surgery for bladder outlet obstruction is being considered. But there is ongoing debate about the extent to which urodynamics should be used, reflecting lack of evidence regarding the effectiveness of urodynamics and how acceptable it is to patients.

What we did

The Urodynamics for Prostate Surgery: Randomised Evaluation of Assessment Methods (UPSTREAM) randomised controlled trial is a 4-year study funded by the National Institute of Health Research Health Technology Assessment Programme (UK). The trial randomised 820 men with LUTS from urology departments in 26 hospitals in England to either a care pathway consisting of non-invasive routine tests, or one of routine tests plus urodynamics. At 18-months after randomisation, UPSTREAM assessed the effect of urodynamics on symptoms and rates of surgery in men with bothersome LUTS seeking further treatment.

In a large qualitative study nested within the UPSTREAM trial, we explored men’s attitudes to and experiences of urodynamics, to provide in‐depth qualitative evidence to inform clinical practice. We interviewed a diverse group of 41 men with LUTS, including those who had had urodynamics and those who had not.

What we found

All 25 men who underwent urodynamics reported that it was acceptable.
Of the 16 men who had not had urodynamics previously, 14 said they would have been willing to have it if needed (with four reporting some apprehension), while two said they would want more information about the test and its purpose.
Among patients who had had urodynamics, the test was well-tolerated, although there was variation in how uncomfortable men found it. Some men experienced short-lived negative after-effects (e.g. stinging, a urinary tract infection), but despite these issues said they would willingly have the test again.
A minority of men reported embarrassment, due to the intimate nature of urodynamics or not being prepared for its effects (e.g. spraying while urinating).
Embarrassment also depended on the degree of privacy available, including the number of people in the room during the test, room location and size (a larger room near a busy corridor was more socially awkward).
Patients valued urodynamics for its diagnostic insight, perceiving it as more informative than other tests. Patients felt that having urodynamics meant they had received all the investigative tests available and so had all possible facts regarding their condition.
Patients described gaps in the information provided by clinicians before, during, and after the test; for example, what to expect when the test was conducted and what the test results meant.
How and when results were explained varied: explanations were given during the test by the technician or nurse undertaking it, from a doctor straight after receiving the test, or at a separate appointment with a doctor a short time later. Men appreciated it when test results were available and discussed with a clinician immediately after the test.
While most men were satisfied with clinicians’ explanation of the results of urodynamics, this was not universal; rushed explanations were highlighted as problematic.

Recommendations

Based on men’s experiences, we recommend:

Good communication before and during the procedure, in line with patient preferences, to ensure patients are well prepared and informed.
Prioritising patient privacy, including minimising the number of people present during the test and introducing the staff members who are present.
Discussing test results with patients promptly, in the amount of detail they wish.
Training and guidance for urology clinicians and urodynamics technicians in these areas.

Acknowledgements

We acknowledge and thank the patients and clinicians involved in the UPSTREAM trial as well as the NHS trusts involved. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) program (project number 12/140/01). This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UKCRC registered clinical trials unit which, as part of the Bristol Trials Centre, is in receipt of National Institute for Health Research CTU support funding. The views and opinions expressed are those of the authors and not necessarily those of the HTA program, NIHR, NHS, or the Department of Health and Social Care.

About the authors:

Dr Selman and Dr Horwood are Senior Research Fellows at University of Bristol, specialising in qualitative research in randomised trials. Twitter: @Lucy_Selman, @JPHorwood

Prof Drake is Professor of Physiological Urology at Bristol Urological Institute, North Bristol NHS Trust, and at Translational Health Sciences, Bristol Medical School, University of Bristol. Twitter: @MarcusDrakeUrol, @UroweESU

Dr Amanda Lewis is a Clinical Trial Manager at the University of Bristol, currently working in the area of Urology research. Twitter: @ALBrooks2015

May Editorial: The Current Hot Topics in Functional Urology

April 18, 2016/by Marcus Drake

For some time, the challenge represented by managing the overactive bladder (OAB) has been dominant in functional urology research. The introduction of new therapies has galvanised the area, with mirabegron showing strong promise for many patients as a monotherapy. In addition, the potential for combined therapy using mirabegron with established antimuscarinics has recently been reported for urgency urinary incontinence [1]. Now that the place of onabotulinum-A injections in refractory cases is firmly established, management options have clearly taken a step forward in recent years. However, there remain people for whom even the more comprehensive current options are inadequate or intolerable. The need for basic science research remains a priority, in the hope of translation into clinical options. In this month’s BJUI, Aizawa et al. [2] report responses in an animal model to an inhibitor of fatty acid amide hydrolase, showing how exploiting the endocannabinoid pathway might be a translational focus for entirely new approaches in OAB. They consider an issue that is very important in developing clinical options, which is that the systems regulating bladder function are also fundamental in other organs, such as the CNS. As the compound they studied does not cross the blood–brain barrier, the potential generation of CNS adverse effects is reduced, which would be important for its potential as a new therapy.

OAB is a symptom syndrome based on storage-type LUTS [3]. Increasingly the field of functional urology is recognising the large number of people who present with voiding and post-micturition LUTS yet do not have BOO. Currently, there are no satisfactory treatment options for affected people and the symptoms can have considerable impact. Frustratingly, current diagnostic methods rely on urodynamic testing to establish whether the presence of detrusor underactivity explains voiding LUTS in an individual patient. Recently, the profession has established a move towards using symptoms to categorise the clinical need in patients [4]. Accordingly, the International Continence Society has established a working group to generate terminology for underactive bladder (UAB), which will report this year, including a symptom-based definition. A symptomatic diagnosis would be very helpful to enable therapy development to proceed without the need for urodynamic testing. Also, in this month’s BJUI, Kajbafzadeh et al. [5] report a clinical trial in UAB using transcutaneous interferential electrical stimulation in children. The treatment was delivered in the context of the rather laborious process currently required for managing this difficult problem, namely diet and fluid manipulation, scheduled voiding, toilet training, and pelvic floor and abdominal muscles relaxation training. The electrical stimulation was demonstrably beneficial, and included responses for the highly troublesome symptom of nocturnal enuresis. The comparatively straightforward nature of this therapeutic approach potentially makes it a valuable tool for dealing with a notoriously difficult problem.

Marcus J. Drake, Senior Lecturer

School of Clinical Sciences, University of Bristol, Bristol, UK

References

1 Drake MJ, Chapple C, Esen AA et al. Efﬁcacy and safety of mirabegron add-on therapy to solifenacin in incontinent overactive bladder patients with an inadequate response to initial 4-week solifenacin monotherapy: a randomised double-blind multicentre phase 3B study (BESIDE). Eur Urol 2016; [Epub ahead of print]. DOI: 10.1016/j.eururo.2016.02.030

2 Aizawa N, Gandaglia G, Hedlund P et al. URB937, a peripherally restricted inhibitor for fatty acid amide hydrolase, reduces prostaglandin E2-induced bladder overactivity and hyperactivity of bladder mechano-afferent nerve ﬁbres in rats. BJU Int 2016; 117: 821–8

3 Abrams P, Cardozo L, Fall M et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub- committee of the International Continence Society. Neurourol Urodyn 2002; 21: 167–78

4 Chapple CR, Osman NI , Birder L et al. The underactive bladder: a new clinical concept? Eur Urol 2015; 68: 351–3

5 Kajbafzadeh AM, Shariﬁ-Rad L, Ladi-Seyedian SS, Mozafarpour S. Transcutaneous interferential electrical stimulation for the management of non-neuropathic underactive bladder in children: a randomised clinical trial. BJU Int 2016; 117: 793–800

Midurethral tape surgery for incontinence; a possible victim of the vaginal mesh crisis?

April 12, 2013/2 Comments/by Marcus Drake

Type 1 mesh is used in vaginal surgery for pelvic organ prolapse repair, along with the mid-urethral tapes for stress incontinence surgery. Tapes for incontinence surgery are well-established and systematic review shows that retropubic tape is probably more effective than colposuspension, risk of bladder perforation notwithstanding [1]. The various types of mid-urethral tape appear to have broadly equivalent efficacy, but the poor quality evidence-base is an issue. The real problem lies with the major complications that can occur, some of which are highlighted in the recent statement from the US Food & Drug Administration in response to concerns expressed by patients and other stakeholders. Mid-urethral tape itself is recognised to be at risk of important complications in the long term, and mesh exposure in the vagina is a major issue with considerable detrimental impact. Patient groups have become organised in recognition of this and they are setting up online dialogues and websites accordingly, for example “tvt-messed-up-mesh.org”. The surgical professions have to agree how best to manage the difficult problems, dealing with the exposed mesh and handling the further procedures needed to re-establish continence [2].

Litigation
These in themselves are serious issues, but another threat is looming; the potential that litigation arising in prolapse mesh surgery may extend to midurethral tapes. A huge number of court cases related to mesh prolapse repair has been established, affecting most of the major device manufacturers and key products, with such a volume of workload that multidistrict litigation has been established. A recent award to one claimant against Johnson & Johnson was more than $5 million. With the number of claimants running into thousands, many device companies are taking decisions on these products which will substantially affect their availability and use in the future. How this will affect mid-urethral tape is uncertain, but many companies will have strategic concerns in this area as well. Reporting of mesh-related adverse events has reasoned exponentially in the last few years [3], presumably resulting from increasing use and increasing awareness of potential problems. Self-reported complications to the FDA’s MAUDE database have risen for all forms of mesh including mid-urethral tapes. Particularly worrying is the potential that tape-related complications after tape placement can happen many years postoperatively [4].

A key aspect of the litigation relating to mesh use in vaginal prolapse surgery is the lack of premarketing testing of these devices and the weak evidence base [5]. Legal arguments involve the responsibility of the companies to demonstrate safety before marketing, and the urological profession has expressed the desirability of more stringent approaches to the development of surgical devices – especially given the highly stringent requirements for pharmaceutical companies in marketing new drugs. The professionals themselves are not blameless; preoperative counselling on risk, judicious selection of surgery according to the patients’ individual requirements, surgical training, careful follow-up and engagement where problems arise have caused difficulties in many cases previously. These points are expectations of professional practice, and the professions need to adhere to them – if necessary with input from governing bodies to ensure adherence is demonstrable. The area is rapidly changing and we can be sure that substantial dialogue and developments are predictable in the near future.
Approaches to management of tape complications
The management of mesh and tape-related complications is specialised and centralisation of management of these cases appears appropriate in order to have the best chance of acceptable outcome and to develop the necessary skills which would not be possible in centres handling only small numbers of cases. Potential complications include voiding dysfunction, mesh exposure, pain, LUTS, and persisting or recurrent incontinence. Voiding dysfunction is particularly likely if a woman already has a preoperative history of voiding symptoms, previous retropubic surgery, or if other reconstructive procedures are undertaken at the time of tape placement [6]. Voiding dysfunction can occur as a result of urethral compression by the tape – which will usually be palpable as an indentation of the urethra at its midpoint. Alternatively, voiding dysfunction arises from elevation of the endopelvic fascia – in which case, the urethra tends to be drawn upwards towards the retropubic space. In the first case, a tape incision can be effective, but in the latter case, an abdominal procedure to release the endopelvic fascia to its normal configuration might be needed. It is important to avoid instrumenting the urethra and levering the urethra downwards with an instrument placed into the urethra – this carries the risk of crushing the urethra against the tape, and is likely a major potential factor for subsequent erosion into the urethra.
The assessment of women with the tape complication needs to be comprehensive and fastidious. The considerations require awareness of tape exposure, incontinence, voiding dysfunction, proximity of adjacent structures, pain points and the state of the vagina/ labia/ pelvis. If mesh is exposed, it is essential to remove the unwanted material, though it may not be necessary to remove the entire tape. The excision of the material may leave a defect within the urethra, bladder or vagina, which needs to be closed- bearing in mind the principles for avoidance of subsequent fistula formation (i.e. watertight closure and interposition of healthy tissue between repaired structures). The woman will seek continence postoperatively and to deliver this, both the bladder outlet and the reservoir capacity of the bladder will need to be considered. If necessary, the woman may need to self-catheterise afterwards, and whether the patient will find this practical and acceptable must be confirmed preoperatively. The possibility that the planned operation may fail has to be considered, and accordingly steps taken to ensure that subsequent options are not excluded. For example, excision of mesh may best be achieved with placement of a flap of omentum into the area of the defect, to keep open the subsequent possibility of artificial urinary sphincter placement. It is very clear that extensive experience in all aspects of reconstructive urology are needed in order to get the best outcome in this context.
The looming threats
The immediate future sees several key challenges, including:
1. Training of surgeons in primary incontinence surgery to minimise risk of complications arising
2. Training of surgeons to manage complications
3. Regulatory arrangements as authorities come to grips with major complications occurring with significant incidence
4. Strategic concerns as device companies change their view of the merit of this indication for their profitability
5. The need for proper data on device use, outcomes and adverse consequences
6. The ongoing need to find new management options for improving efficacy and safety in surgical management of incontinence

Professional consensus and dialogue is clearly a high priority to ensure a good outcome for all.

Dr Marcus Drake is Consultant Surgeon at the Bristol Urological Institute, Bristol, UK, subspecialising in Female and Reconstructive Urology, Neurourology and Urodynamics He is Chairman of the International Continence Society’s Standardisation Steering Committee

References
1. Novara, G., et al., Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol, 2010. 58(2): p. 218-38.
2. Smith, A.R., W. Artibani, and M.J. Drake, Managing unsatisfactory outcome after mid-urethral tape insertion. Neurourol Urodyn, 2011. 30(5): p. 771-4.
3. Shah, H.N. and G.H. Badlani, Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review. Indian journal of urology : IJU : journal of the Urological Society of India, 2012. 28(2): p. 129-53.
4. Jones, R., et al., Risk of tape-related complications after TVT is at least 4%. Neurourol Urodyn, 2010. 29(1): p. 40-1.
5. Abrams, P., et al., Synthetic vaginal tapes for stress incontinence: proposals for improved regulation of new devices in Europe. Eur Urol, 2011. 60(6): p. 1207-11.
6. Molden, S., et al., Risk factors leading to midurethral sling revision: a multicenter case-control study. Int Urogynecol J Pelvic Floor Dysfunct, 2010. 21(10): p. 1253-9.

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