Angie Rantell (left) and Professor Linda Cardozo discussthe latest evidence-based recommendations formanaging urinary incontinence in women


In 2006 the National Institute for Health and Care Excellence (NICE) published guidance on The management of urinary incontinence in women.1 This document was developed to provide guidance on the initial and ongoing assessment and investigation of women presenting with stress urinary incontinence (UI), overactive bladder syndrome (OAB), and mixed UI. The guideline also contained advice on the appropriate use of conservative and surgical treatment options, and notes on the required competencies of surgeons who perform these operations.1

The NICE guideline has proved to be a highly beneficial resource for many healthcare professionals, especially those in primary care who often see patients when they initially present complaining of UI. However, during the past 4 years new drugs and treatment options have been developed, and more research has been undertaken in this specialist field. Therefore, are the recommendations made by NICE still valid?

This article reviews the most recent evidence that is in line with the NICE recommendations, and also highlights some of the areas of the NICE guideline that may need reconsideration and updating. The authors also discuss the difficulties still experienced in primary care regarding implementation of this guidance, and issues highlighted in secondary care concerning the inappropriate interpretation of the guideline by primary care, which can then lead to issues in secondary care.

Terminology

The terminology used to define the different types of incontinence needs to be updated. The terms used in the NICE guidance were based on the International Continence Society’s (ICS) standardised terminology for lower urinary tract function, published in 2002.2 However, these were recently revised by a joint committee from the ICS and the International Urogynaecology Association (IUGA), and new terminology for female pelvic floor dysfunction has been instigated.3 These were revised using a female-specific approach and a clinically based consensus report.

Immediate-release vs extended-release oxybutynin

One of the most contentious recommendations in the NICE guideline was the use of immediate-release (IR) oxybutynin as a first-line pharmacological therapy for patients with symptoms of OAB.1 This still remains an area for debate given the high discontinuation rates with these drugs.4 According to a recent study by Basu et al, 72% of clinicians felt that IR oxybutynin should not be used as the first-line therapy.5 Although one can argue that adherence to therapy is poor for all antimuscarinic drugs, there are studies which report that other available drugs are better tolerated.6 One group found that adherence to therapy was significantly better in patients taking extended release-formulations compared with IR preparations of oxybutynin.7

Patient adherence to prescribed therapy is affected by:8

  • perceived benefit
  • pill burden
  • complexity of dosing schedule
  • memory lapses
  • adverse events.

Given the issues affecting adherence, it could be suggested that IR oxybutynin is the least suitable preparation as it requires more tablets to be taken at several times throughout the day, and has a large side-effect profile including cognitive dysfunction, especially in the elderly population.

There have been several new preparations of antimuscarinics for the treatment of OAB launched in the UK over the past 4 years (since the publication of the NICE guideline). Fesoterodine fumarate is a new agent, and extended-release preparations of trospium chloride and propiverine are also available.

Posterior tibial nerve stimulation

One of the recommendations made by NICE was the need for a robust evaluation of percutaneous posterior tibial nerve stimulation (PTNS) for the treatment of UI.9 Following a number of recent studies to assess this treatment option,9 a NICE interventional procedure review is currently in progress and is due for publication in autumn 2010. If this review recommends the use of PTNS for women with OAB, this will also need to be included in an update to the full guideline.

International Consultation on Incontinence

The Fourth International Consultation on Incontinence (ICI) was organised in 2008 by the International Consultation on Urological Diseases—a non-governmental organisation—in official collaboration with the World Health Organization, in order to develop recommendations for the diagnosis, evaluation, and treatment of UI, faecal incontinence, pelvic organ prolapse, and bladder pain syndrome.10,11 The outputs were published in 2009 and, although many of the recommendations are in line with the NICE guideline, there are several differences.

One difference is the length of time that conservative therapies should initially be offered for. For women with OAB, NICE recommends 6 weeks of bladder retraining before considering anti-muscarinic therapy,1,9 whereas the ICI recommends at least 8–12 weeks.11 If this recommendation was to be transferred into the NICE guidance it may impact positively on the number of patients that need to proceed to pharmacological management or, conversely, some women may feel that this time period is too long, especially if conservative therapies are failing to manage their symptoms, resulting in disillusionment and poor adherence to therapy. The ICI recommendations are included in Boxes 1 and 2.

Box 1: International Consultation on Incontinence recommendations on the initial management of urinary incontinence in women10

Abrams P, Andersson K, Birder L et al. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and faecal incontinence. Neurourol Urodyn 2010; 29: 213–240. Reproduced with permission.

Box 2: International Consultation on Incontinence recommendations on specialised management of urinary incontinence in women10

Abrams P, Andersson K, Birder L et al. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and faecal incontinence. Neurourol Urodyn 2010; 29: 213–240. Reproduced with permission.

Urodynamics

Another point that has been debated is the recommendation that urodynamics are not necessary before surgery in woman who complain of pure stress UI.1 Two studies found that this type of pure UI does not exclude other abnormalities of lower urinary tract function.12,13 The ICI-CDT (International Consultation on Incontinence 2008–Committee on dynamic testing for urinary incontinence and for faecal incontinence) recently published an evidence-based and consensus committee report. The committee recommends that urodynamic study (UDS) is carried out in all women prior to surgical intervention for stress UI and suggests that a well-designed, prospective, multicenter study should address the question as to whether women with symptoms of pure stress UI are more at risk of failure from treatment without UDS.14 This is relevant to primary care because patients will need to be counselled appropriately about referral for UDS.

Implementation issues

Currently the biggest issue in the implementation of the NICE guideline is in the provision of continence services in the primary care setting. Integrated continence services, as recommended in the Department of Health documents Good practice in continence services15 and the National service framework for older people,16 are still to be established in many areas of the UK. This lack of appropriately trained primary care healthcare professionals means that many of the recommendations made by NICE, such as supervised bladder retraining and pelvic floor muscle training, are not available to all women who present with UI—women may be provided with a leaflet on the principles and techniques to use; however, this has proved to be less effective for many women.11

Issues arising from secondary care

When patients are referred into secondary care following failure of conservative therapies, there are some concerns raised by secondary care staff—one being patients who have received inappropriate treatment in primary care. Secondary care staff often see referral letters stating: ‘This patient complains of stress incontinence, a trial of oxybutynin has been ineffective.’ This highlights a need for improved education in the primary care setting. It is acknowledged that GPs need to have a broad knowledge of many medical conditions and only a few have a specialist interest or in-depth knowledge of female UI. However, the NICE guideline provides definitions and advice to help overcome incorrect diagnosis and management.1,9 Table 1 may be beneficial in establishing a differential diagnosis for women complaining of UI.

One of the red flags covered by NICE is that all women presenting with a symptomatic prolapse that is visible at or below the vaginal introitus should be referred directly into secondary care.1,9 However, it could be argued that all women complaining of a symptomatic prolapse should be referred for specialist assessment regardless of the degree of prolapse on initial examination. A vaginal prolapse can change in size throughout the day (often reduced in the morning and more palpable after standing for long periods throughout the day). Examination findings will also depend on the position in which the woman is examined—prolapse is usually larger on standing due to the effect of gravity on the pelvic floor—yet in the primary care setting very few women are examined in a standing position, hence the need for specialist intervention in all symptomatic women.

There is a lack of guidance on UI associated with incomplete bladder emptying. Although recommended on initial assessment, an ultrasound scan or ‘in and out’ catheter to assess residual urine are not normally performed unless a woman has a palpable bladder;1 however, the bladder will only be palpable when it contains in excess of 300 ml of urine.17 Symptoms of overflow incontinence are often mistaken for OAB and treatment in line with this incorrect diagnosis may worsen a woman’s incontinence. This again highlights the need for improved education for those primary care healthcare professionals who perform the initial clinical assessment.

Table 1: Differential diagnosis of female urinary incontinence
Symptom assessment
Symptom Overactive bladder Stress incontinence Mixed symptoms
Urgency (strong, sudden desire to void) Yes No Yes
Frequency with urgency (>8 times/24 hr) Yes No Yes
Leaking during physical activity (e.g. coughing, sneezing, lifting) No Yes Yes
Amount of urinary leakage with each episode of incontinence Large
(if present)
Small Variable
Ability to reach the toilet in time following and urge to void Often no Yes Variable
Waking to pass urine at night Usually Seldom Maybe

 

Summary

Although this article has not provided an exhaustive review of all the current issues relating to the NICE guideline on female UI, it has highlighted several areas where further consideration could help to bring this guidance in line with the most recent evidence-based practice. That said, the NICE guideline has proved to be beneficial for many primary care healthcare professionals in the assessment, diagnosis, and treatment of women with UI, thereby improving the experience and outcomes of patients. One possible way forward may be for NICE to collaborate with the ICI committee to produce one set of guidelines that is appropriate to the UK population and feasible within the scope of the NHS.

References

  1. National Institute for Health and Care Excellence. Urinary incontinence: the management of urinary incontinence in women. Clinical Guideline 40. London: NICE, 2006. Available at: www.nice.org.uk/guidance/CG40
  2. Abrams P, Cardozo L, Fall M et al. The standardization of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21 (2): 167–178.
  3. Haylen B, Riddler D, Freeman R et al. An International Urogynaecological Association IUGA/International Continence Society ICS joint report on the terminology for female pelvic floor dysfunction. Int Urogynaecol J Pelvic Floor Dysfunct 2010; 21 (1): 5–26.
  4. Gopal M, Haynes K, Bellamy S, Arya L. Discontinuation rates of anticholinergic medications used for the treatment of lower urinary tract symptoms. Obstet Gynecol 2008 112 (6): 1311–1318.
  5. Basu M, Duckett J, Moran P, Freeman R. Clinicians’ view of the NICE guidelines on the management of female urinary incontinence. J Obs Gynaecol 2009; 29 (6): 529–532.
  6. Anderson R, Mobley D, Blank B et al. Once daily controlled versus immediate release oxybutynin chloride for urge urinary incontinence. OROS Oxybutynin Study Group. J Urol 1999; 161 (6): 1809–1812.
  7. D’Souza A, Smith M, Miller L et al. Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. J Manag Care Pharm 2008; 14 (3): 291–301.
  8. MacDiarmid S. The evolution of transdermal/topical overactive bladder therapy and its benefits over oral therapy. Rev Urol 2009; 11 (1): 1–6.
  9. National Collaborating Centre for Women’s and Children’s Health. Urinary incontinence: the management of urinary incontinence in women. London: RCOG Press, 2006. Available at: www.nice.org.uk/guidance/CG40
  10. Abrams P, Andersson K, Birder L et al. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and faecal incontinence. Neurourol Urodyn 2010; 29: 213–240.
  11. Abrams P, Cardozo L, Khoury S, Wein A (Eds). Incontinence, 4th edition. Health Publications Ltd, 2009.
  12. Lemack G, Zimmern P. Identifying patients who require urodynamic testing before surgery for stress incontinence based on questionnaire information and surgical history. Urology 2000; 55 (4): 506–511.
  13. Colli E, Artibani W, Goka J et al. Are urodynamic tests useful tools for the initial conservative management of non-neurogenic urinary incontinence? A review of the literature. Eur Urol 2003; 43 (1): 63–69.
  14. Rosier P, Gajewski J, Sand P et al. Executive Summary: the International Consultation on Incontinence 2008—Committee on ‘Dynamic Testing’ for Urinary Incontinence and for Fecal Incontinence. Part 1: Innovations in urodynamic techniques and urodynamic testing for signs and symptoms of urinary incontinence in female patients. Neurourol Urodyn 2010; 29 (1): 140–145.
  15. Department of Health. Good practice in continence services. London: DH, 2000.
  16. Department of Health. National service framework for older people. London: DH, 2001.
  17. Abrams P. Urodynamics, 3rd edition. London: Springer, 2006.G
  • Urinary incontinence in women is a major cause of disability and symptoms but is often not managed optimally
  • Commissioners should consider establishing a specialist community continence service, which can be nurse led
  • This service should help inform and educate primary care clinicians
  • Commissioners should liaise with secondary care specialist clinicians and establish local care pathways based on these guidelines
  • Effective community services can reduce the costs of hospital referral and can be commissioned outside the Payment by Results tariff
  • Continence services have often been provided through PCT provider arms— these services will need to be hosted elsewhere from April 2011
  • Tariff costs:a
    • gynaecology outpatient = £135 (new), £74 (follow up)
    • urology outpatient = £194 (new), £96 (follow up)
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