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National Collaborating Centre for Women's and Children's Health (UK). Urinary Incontinence: The Management of Urinary Incontinence in Women. London: RCOG Press; 2006 Oct. (NICE Clinical Guidelines, No. 40.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

1Introduction

1.1. Urinary incontinence

Urinary incontinence (UI) is a common symptom that can affect women of all ages, with a wide range of severity and nature. While rarely life-threatening, incontinence may seriously influence the physical, psychological and social wellbeing of affected individuals. The impact on the families and carers of women with UI may be profound, and the resource implications for the health service considerable.

The International Continence Society (ICS) has standardised terminology in lower urinary tract function: UI is defined as ‘the complaint of any involuntary urinary leakage’.1 This may occur as a result of a number of abnormalities of function of the lower urinary tract, or as a result of other illnesses, and these tend to cause leakage in different situations. Definitions for stress, mixed and urge UI and overactive bladder (OAB) are given in the glossary. Other types of UI may be described by the situations that provoke urine loss, for example during sexual intercourse, or on laughing or giggling. Some patients may simply report being ‘wet all the time’. This may be a reflection of the severity of their condition, although may on occasions be due to other pathologies, for example fistula. There are currently approximately 80 cases of fistula between the urinary tract and genital tract treated each year in England and Wales and this condition is not considered further in this guideline. It is recognised that UI may be of a transient nature on occasion, reflecting acute health or environmental factors.

Prevalence and incidence

Urinary incontinence is an embarrassing problem to many women and thus its presence may be significantly underreported. In a UK community study, the prevalence of UI known to the health and social service agencies was 0.2% in women aged 15–64 years and 2.5% in those aged 65 and over.2 A concurrent postal survey showed a prevalence of 8.5% in women aged 15–64 and 11.6% in those aged 65 and over. Incontinence was described as ‘moderate’ or ‘severe’ in one-fifth of those who reported it and, even among these, fewer than one-third were receiving health or social services for the condition.2

The Leicestershire MRC Incontinence Study, of individuals over 40 years of age, found that 33.6% of the population reported significant urinary symptoms but only 6.2% found these bothersome, and only 2.4% both bothersome and socially disabling. Of the population surveyed, 3.8% (one in nine of those with clinically significant symptoms) felt the need for help with their symptoms.3,4 Some women may not see their UI as a major problem. For others, who do perceive a problem with which they would like help, there are often barriers to presentation. Women may take up to 10 years before seeking help.5 They may be too embarrassed to seek advice, may not wish to bother their general practitioner (GP), may believe UI to be a normal consequence of the ageing process or may not appreciate that treatments are available.6

Differences in study populations, the definition and measurement of UI, and the survey method used result in a wide range of prevalence estimates.7 Where the most inclusive definitions have been used (‘ever’, ‘any’, ‘at least once in the last 12 months’), prevalence estimates in the general population range from 5% to 69% in women 15 years and older, with most studies in the range 25–45%.7 There appears to be less variation in the prevalence of more severe UI and estimates in the general population range between 4% and 7% in women under 65 years, and between 4% and 17% in those over 65 for daily UI.7 The Leicestershire MRC Incontinence Study found that, while 34.2% of women reported UI at times, only 3.5% experienced the symptom on a daily basis, 11.8% weekly, 7.3% monthly and 11.6% yearly.8

Several studies have shown that the prevalence of any UI tends to increase up to middle age, then plateaus or falls between 50 and 70 years, with a steady increase with more advanced age. The EPINCONT survey, of women aged over 20 years from Norway, illustrates this point (Figure 1.1). These data also show that slight to moderate UI is more common in younger women, while moderate and severe UI affects the elderly more often.9,10

Figure 1.1. Prevalence of incontinence by age group and severity.

Figure 1.1

Prevalence of incontinence by age group and severity.

Stress UI appears to be the most common UI type and overall 50% of incontinent women in the EPINCONT survey reported this as their only symptom; 11% described only urge UI and 36% reported mixed UI.9 This and other studies indicate that the trends in prevalence of UI at different ages reflect a reduction in the complaints of stress UI in those aged 50 years and over, with an increase in urge UI and mixed UI in women aged 60 years and above (Figure 1.2).9,11 This study also found that the severity of incontinence varied between the different types: the proportion of incontinence that was regarded as being severe was 17%, 28% and 38% in the stress, urge and mixed UI groups, respectively.9

Figure 1.2. Prevalence of UI types by age group.

Figure 1.2

Prevalence of UI types by age group.

There are relatively little epidemiological data on the prevalence of OAB syndrome. A telephone survey from the USA found an overall prevalence of OAB wet of 9.6% in women over 18 years of age, rising from 5% in those aged 18–44 to 19% in those over 65.12 Survey data from Europe found prevalence of the same order.13 The Leicestershire MRC Incontinence Study found an overall prevalence of OAB in women aged 40 and over of 21.4%.14

It has been estimated that, while not all may need or want help, 20.4% of people aged 40 years and over, representing around 5 million people in the UK, have a healthcare requirement.8 In women aged 40 and over this figure increases from 20.5% aged 40–49 up to 35.6% at age 80 and over.

Risk factors

In addition to the effect of age, cross-sectional studies suggest other associations and possible risk factors for UI. These include pregnancy, parity, obstetric factors, menopause, hysterectomy, obesity, lower urinary tract symptoms, functional impairment, cognitive impairment, smoking, family history, diet and genetics. Urinary incontinence may be a presenting symptom of neurological disease.

Costs and implications for health services

Costs to patients and carers

Urinary incontinence is distressing and socially disruptive. It may be the cause of personal health and hygiene problems. It may restrict employment and educational or leisure opportunities, and lead to embarrassment and exclusion. Furthermore, for some, it may result in abuse of adults in the workplace and older people in residential care or nursing homes. In adult women with UI, 60% avoid going away from home, 50% feel odd or different from others, 45% avoid public transport and 50% report avoiding sexual activity through fear of incontinence.15 Serious psychiatric morbidity has been reported in one-quarter of women attending hospital for investigation of UI.16 For carers, UI is often a major reason for the breakdown of the caring relationship which can lead to admission to residential or nursing home care; incontinence is second only to dementia as an initiating factor for such moves.17 Financial costs to patients and carers, including the cost of absorbent products, laundry, etc., may also be considerable.

Costs to the health services

There is limited information on the cost of managing UI in the UK although the estimated total cost in the USA in 1995 was $12.4bn (£7bn), with the vast majority of this relating to community or nursing home care ($8.6bn and $3.8bn [£5bn and £2.2bn], respectively).18 These costs are of a similar order to those associated with gynaecological cancers, osteoporosis, pneumonia and influenza, and arthritis,18 and in the USA and Sweden are equivalent to approximately 2% of the total healthcare budget.19 With current UK health spending of £90bn, this would approximate to £1.8bn annually in England and Wales, or perhaps £600 per incontinent individual. Data from the Leicestershire MRC Incontinence Study estimates the annual cost to the NHS of treating clinically significant UI at £536m (£233m for women). The total annual service costs (including costs borne by individuals) were estimated at £743m.20

A recent study of the costs of care for women seeking treatment for UI across Europe (the PURE study), determined that the mean UI-related costs per year ranged from €359 (£248) in the UK/Ireland (where patients were predominantly treated by their GPs) to €515 (£355) in Germany and €655 (£452) in Spain (where the initial referral may sometimes be to specialists and sometimes to GPs).5

Health-related costs of managing OAB in the USA have been estimated at around $9bn (£5bn), the cost patterns raising the possibility that treating OAB at an early stage may both improve patient care and minimise overall use of healthcare resources.21

1.2. Aim of the guideline

This clinical guideline concerns the management of UI in adult women. It includes:

  • stress UI
  • OAB (with or without urge UI)
  • mixed UI.

It has been developed with the aim of providing guidance on:

  • initial and ongoing assessments and investigations
  • appropriate use of conservative and surgical treatment options
  • the competence required by surgeons performing the primary and subsequent operative procedures.

1.3. Areas outside the remit of the guideline

This guideline does not address:

  • the management and treatment of co-morbidities, such as pelvic organ prolapse (POP), except where they relate to the treatment of UI and/or OAB syndrome
  • incontinence caused by neurological disease
  • incontinence in men
  • incontinence in children
  • anal incontinence.

1.4. For whom is the guideline intended?

This guideline is of relevance to those who work in or use the NHS in England and Wales, in particular:

  • all healthcare professionals who are involved in the care of women who have UI or OAB syndrome (including GPs, nurses, physiotherapists, gynaecologists, urologists and occupational therapists). The healthcare professionals providing care for women with UI or OAB may vary depending on geographical service provision.
  • those responsible for commissioning and planning healthcare services, including primary care trust commissioners, Health Commission Wales commissioners, and public health, trust and care home managers
  • women with UI and/or OAB syndrome, their families and other carers.

A version of this guideline for the public is available from the NICE website (www.nice.org.uk/CG040publicinfo) or from the NHS Response Line (0870 1555 455); quote reference number N1129).

1.5. Who has developed the guideline?

The guideline was developed by a multi-professional and lay working group (the Guideline Development Group or GDG) convened by the National Collaborating Centre for Women’s and Children’s Health (NCC-WCH). The membership is listed above. Staff from the NCC-WCH provided support for the guideline development process by undertaking systematic searches, retrieval and appraisal of the evidence and health economic modelling, and wrote successive drafts of the guideline.

All GDG members’ potential and actual conflicts of interest were recorded on a declaration form provided by NICE and are shown in Appendix A. The form covered consultancies, fee-paid work, shareholdings, fellowships, and support from the healthcare industry. The GDG leader and NCC-WCH executive director consider that the declarations made did not influence the recommendations developed.

1.6. Other relevant documents

This guideline is intended to complement other existing and proposed works of relevance, including related NICE guidance:

  • Guidelines:

    Infection Control: Prevention of Healthcare-Associated Infection in Primary and Community Care22

    Referral Guidelines for Suspected Cancer23

    Routine Postnatal Care of Women and Their Babies24

    Faecal Incontinence (in development – expected date of issue June 2007).

  • Cancer service guidance:

    Improving Outcomes in Urological Cancer: the Manual.25

  • Interventional procedures:

    Sacral Nerve Stimulation for Urge Incontinence and Urgency-Frequency.26

    Intramural Urethral Bulking Procedures for Stress Urinary Incontinence in Women27

    Insertion of Extraurethral (Non-Circumferential) Retropubic Adjustable Compression Devices for Stress Urinary Incontinence in Women28

    Insertion of Biological Slings for Stress Urinary Incontinence in Women29

    Bone-Anchored Cystourethropexy.30

Other than NICE guidance, relevant works are:

  • the third International Consultation on Incontinence (ICI) (2005)31,32
  • the Royal College of Physicians report on incontinence (1995)33
  • the Department of Health’s Good Practice in Continence Services (2000)34
  • the National Service Framework for Older People (2001).35

1.7. Guideline method

This guideline was commissioned by NICE and developed in accordance with the guideline development process outlined in the NICE technical manual.36

Literature search strategy

Initial scoping searches were executed to identify relevant guidelines (local, national and international) produced by other development groups. The reference lists in these guidelines were checked against subsequent searches to identify missing evidence.

Relevant published evidence to inform the guideline development process and answer the clinical questions was identified by systematic search strategies. The questions are shown in Appendix B. Additionally, stakeholder organisations were invited to submit evidence for consideration by the GDG provided it was relevant to the clinical questions and of equivalent or better quality than evidence identified by the search strategies.

Systematic searches to answer the clinical questions formulated and agreed by the GDG were executed using the following databases via the ‘Ovid’ platform: Medline (1966 onwards), Embase (1980 onwards), Cumulative Index to Nursing and Allied Health Literature (1982 onwards), British Nursing Index (1985 onwards) and PsycINFO (1967 onwards). The most recent search conducted for the three Cochrane databases (Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects) was Quarter 1, 2006. The Allied and Complementary Medicine Database (AMED) was also used for alternative therapies (1985 onwards via the Datastar platform). Searches to identify economic studies were undertaken using the above databases and the NHS Economic Evaluations Database (NHS EED).

Search strategies combined relevant controlled vocabulary and natural language in an effort to balance sensitivity and specificity. Unless advised by the GDG, searches were not date specific. Language restrictions were not applied to searches. Both generic and specially developed methodological search filters were used appropriately.

There was no systematic attempt to search grey literature (conferences, abstracts, theses and unpublished trials). Hand searching of journals not indexed on the databases was not undertaken.

Towards the end of the guideline development process, searches were updated and re-executed, thereby including evidence published and included in the databases up to 17 March 2006. Any evidence published after this date was not included. This date should be considered the starting point for searching for new evidence for future updates to this guideline.

Further details of the search strategies, including the methodological filters employed, are available on the accompanying CD-ROM.

Synthesis of clinical effectiveness evidence

Evidence relating to clinical effectiveness was reviewed using established guides37–43 and classified using the established hierarchical system shown in Table 1.1.36 This system reflects the susceptibility to bias that is inherent in particular study designs.

Table 1.1. Levels of evidence for intervention studies.

Table 1.1

Levels of evidence for intervention studies.

The type of clinical question dictates the highest level of evidence that may be sought. In assessing the quality of the evidence, each study receives a quality rating coded as ‘++’, ‘+’ or ‘−’. For issues of therapy or treatment, the highest possible evidence level (EL) is a well-conducted systematic review or meta-analysis of randomised controlled trials (RCTs; EL = 1 + +) or an individual RCT (EL = 1+). Studies of poor quality are rated as ‘−’. Usually, studies rated as ‘−’ should not be used as a basis for making a recommendation, but they can be used to inform recommendations. For issues of prognosis, the highest possible level of evidence is a cohort study (EL = 2). A level of evidence was assigned to each study, and to the body of evidence for each question.

For each clinical question, the highest available level of evidence was selected. Where appropriate, for example if a systematic review, meta-analysis or RCT existed in relation to a question, studies of a weaker design were not included. Where systematic reviews, meta-analyses and RCTs did not exist, other appropriate experimental or observational studies were sought. For diagnostic tests, test evaluation studies examining the performance of the test were used if the efficacy of the test was required, but where an evaluation of the effectiveness of the test in the clinical management of patients and the outcome of disease was required, evidence from RCTs or cohort studies was optimal.

The system described above covers studies of treatment effectiveness. However, it is less appropriate for studies reporting diagnostic tests of accuracy. In the absence of a validated ranking system for this type of test, NICE has developed a hierarchy for evidence of accuracy of diagnostic tests that takes into account the various factors likely to affect the validity of these studies (Table 1.2).36

Table 1.2. Levels of evidence for studies of the accuracy of diagnostic tests.

Table 1.2

Levels of evidence for studies of the accuracy of diagnostic tests.

For economic evaluations, no standard system of grading the quality of evidence exists. Economic evaluations that are included in the review have been assessed using a quality assessment checklist based on good practice in decision-analytic modelling.44

Evidence was synthesised qualitatively by summarising the content of identified papers in evidence tables and agreeing brief statements that accurately reflected the evidence. Quantitative synthesis (meta-analysis) was performed where appropriate. Where confidence intervals were calculated, this was done in accordance with accepted methods.45 Summary results and data are presented in the guideline text. More detailed results and data are presented in the evidence tables on the accompanying CD-ROM, where a list of excluded studies is also provided.

Specific considerations for this guideline

It was anticipated that some evidence relevant to this guideline would not be specific to women with UI and thus studies with mixed populations (men and women, and/or with UI of different aetiology) were considered if the majority of the population was women with idiopathic UI or OAB.

Published guidance from the NICE Interventional Procedures (IP) Programme was considered, alongside all relevant evidence in women with UI or OAB when an interventional procedure was approved for use. Where the IP guidance states that an interventional procedure is not for routine use, the procedure was not considered within this guideline.

The NICE health technology appraisal on tension-free vaginal tape (2003) was updated within this guideline by addressing a question on the intervention. The associated NICE guidance will be withdrawn on publication of this guideline.

The classification of adverse effect frequency used by the Medicines and Healthcare products Regulatory Agency (MHRA) was adopted within the guideline, as shown in Table 1.3.

Table 1.3. MHRA classification of adverse effect frequency.

Table 1.3

MHRA classification of adverse effect frequency.

Health economics

The aims of the economic input into the guideline were to inform the GDG of potential economic issues relating to UI in women and to ensure that recommendations represent a cost effective use of healthcare resources.

The health economist helped the GDG by identifying topics within the guideline that might benefit from economic analysis, reviewing the available economic evidence and, where necessary, conducting economic analysis. Reviews of published health economic evidence are presented alongside the reviews of clinical evidence, and modelling is presented in the appendices, with cross references from the relevant chapters.

Outcome measures used in the guideline

For this guideline, treatment has been assessed against a number of outcome domains, as follows:

  • the woman’s observations, including changes in symptoms and satisfaction
  • generic and incontinence-specific aspects of quality of life (QOL)
  • the clinician’s observations including urodynamic investigation and quantification of incontinence
  • harm (adverse effects, surgical complications)
  • health economic outcomes, for example quality-adjusted life years (QALYs).

Forming and grading recommendations

For each guideline question, recommendations were derived using, and explicitly linked to, the evidence that supported them. In the first instance, informal consensus methods were used by the GDG to agree evidence statements and recommendations. Additionally, in areas where no substantial evidence existed, the GDG considered other guidelines or consensus statements to identify current best practice. Shortly before the consultation period, formal consensus methods were used to agree guideline recommendations (modified Delphi technique) and to select five to ten key priorities for implementation (nominal group technique).

Each recommendation was graded according to the level of evidence upon which it was based, using the established systems shown in Tables 1.4 and 1.5. For issues of therapy or treatment, the best possible level of evidence (a systematic review or meta-analysis or an individual RCT) equates to a grade A recommendation. For issues of prognosis, the best possible level of evidence (a cohort study) equates to a grade B recommendation. However, this should not be interpreted as an inferior grade of recommendation because it represents the highest level of relevant evidence.

Table 1.4. Classification (grading) of recommendations for intervention studies.

Table 1.4

Classification (grading) of recommendations for intervention studies.

Table 1.5. Classification (grading) of recommendations for studies of the accuracy of diagnostic tests.

Table 1.5

Classification (grading) of recommendations for studies of the accuracy of diagnostic tests.

In addition, the GDG made research recommendations in areas where evidence is lacking.

External review

This guideline has been developed in accordance with the NICE guideline development process. This has included giving registered stakeholder organisations the opportunity to comment on the scope of the guideline at the initial stage of development and on the evidence and recommendations at the concluding stage. In addition, the guideline was peer reviewed by nominated individuals. The developers have carefully considered all of the comments during the consultation periods by registered stakeholders with validation by NICE.

1.8. Schedule for updating the guideline

Clinical guidelines commissioned by NICE are published with a review date 4 years from the date of publication. Reviewing may begin earlier than 4 years if significant evidence that affects guideline recommendations is identified sooner. The updated guideline will be available within 2 years of the start of the review process.

Copyright © 2006, National Collaborating Centre for Women’s and Children’s Health.

No part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK [www.cla.co.uk]. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

Cover of Urinary Incontinence
Urinary Incontinence: The Management of Urinary Incontinence in Women.
NICE Clinical Guidelines, No. 40.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2006 Oct.

NICE (National Institute for Health and Care Excellence)

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