• National Collaborating Centre for Women's and Children's Health. Urinary incontinence: the management of urinary incontinence in women. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2006 Oct. 221 p. [960 references]

This is the current release of the guideline.

Clinical guidelines commissioned by National Institute for Health and Clinical Excellence (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.

Urinary incontinence (UI) including:

• Stress UI
• Overactive bladder (OAB) with or without urge UI
• Mixed UI

Note: UI is defined as "the complaint of any involuntary urinary leakage." This guideline does not address the management and treatment of co-morbidities (such as pelvic organ prolapse, except where they relate to the treatment of urinary incontinence   and/or overactive bladder syndrome), incontinence caused by neurological disease, incontinence in men, incontinence in children, or anal incontinence.

Diagnosis
Evaluation
Management
Treatment

Family Practice
Geriatrics
Internal Medicine
Obstetrics and Gynecology
Physical Medicine and Rehabilitation
Surgery
Urology

Allied Health Personnel
Health Care Providers
Nurses
Occupational Therapists
Patients
Physical Therapists
Physicians
Public Health Departments

This clinical guideline 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

• Women with urinary incontinence
• Women with overactive bladder syndrome

Diagnosis/Evaluation

1. History taking and physical examination
2. Digital assessment of pelvic floor muscle contraction
3. Assessment of prolapse
4. Urine testing, including dipstick (blood, glucose, protein, leucocytes and nitrites) and midstream culture
5. Measurement of post-void residual urine volume, including bladder scan and catheterization
6. Referral to specialist
7. Symptom scoring and quality of life (QOL) assessment
8. Bladder diary
9. Urodynamic testing, if appropriate

Management/Treatment

1. Lifestyle interventions, including weight loss, caffeine reduction
   • Caffeine reduction
   • Modification of fluid intake
   • Weight loss
2. Physical therapies
   • Pelvic floor muscle training
   • Biofeedback
   • Electrical stimulation
3. Behavioral therapies, including bladder training programs
4. Drug therapies
   • Antimuscarinic drug therapy
   • Propiverine
   • Desmopressin
   • Intravaginal estrogens
5. Non-therapeutic interventions
   • Absorbent products, hand-held urinals, and toileting aids
   • Bladder catheterization (intermittent or indwelling urethral or suprapubic)
   • Intravaginal and intraurethral devices
6. Preventive use of conservative therapies
   • Pelvic floor muscle training during pregnancy
7. Surgical procedures for overactive bladder
   • Sacral nerve stimulation
   • Augmentation cystoplasty
   • Urinary diversion
   • Bladder wall injection with botulinum toxin A
8. Surgical procedures for stress urinary incontinence
   • Retropubic mid-urethral tape procedures
   • Open colposuspension
   • Autologous rectus fascial sling
   • Synthetic slings
   • Laparoscopic colposuspension
   • Intramural bulking agents

• Changes in symptoms
• Patient satisfaction
• Generic and incontinence-specific aspects of quality of life (QOL)
• Urodynamic investigation
• Quantification of incontinence
• Harm (adverse effects, surgical complications)
• Health economic outcomes, for example quality-adjusted life years

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

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 in the original full-length guideline document.

Additionally, stakeholder organisations were invited to submit evidence for consideration by the guideline development group (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 National Health Service 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.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

Levels of Evidence for Intervention Studies

Levels of Evidence for Studies of the Accuracy of Diagnostic Tests

^a Homogeneity means there are minor or no variations in the directions and degrees of results between individual studies that are included in the systematic review.

^b Level-1 studies are studies that use a blind comparison of the test with a validated reference standard ('gold' standard) in a sample of patients that reflects the population to whom the test would apply.

^c Level-2 studies are studies that have only one of the following:

• Narrow population (the sample does not reflect the population to whom the test would apply)
• Use a poor reference standard (defined as that where the 'test' is included in the 'reference', or where the 'testing' affects the 'reference')
• The comparison between the test and reference standard is not blind
• Case-control studies

^d Level-3 studies are studies that have at least two or three of the features listed above.

Meta-Analysis
Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Synthesis of Clinical Effectiveness Evidence

Evidence relating to clinical effectiveness was reviewed using established guides and classified using the established hierarchical system shown above in the "Rating Scheme for the Strength of the Evidence." This system reflects the susceptibility to bias that is inherent in particular study designs.

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, National Institute for Health and Clinical Excellence (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 (shown above in "Rating Scheme for the Strength of the Evidence.").

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.

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. Summary results and data are presented in the guideline text.

Specific Considerations for this Guideline

It was anticipated that some evidence relevant to this guideline would not be specific to women with urinary incontinence (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 overactive bladder (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 in the original full-length guideline document.

Expert Consensus
Expert Consensus (Delphi)
Expert Consensus (Nominal Group Technique)

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 Guideline Development Group (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 described below in the "Rating Scheme for the Strength of the Recommendations." 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.

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

Classification (Grading) of Recommendations for Intervention Studies

Classification (Grading) of Recommendations for Studies of the Accuracy of Diagnostic Tests

DS, diagnostic study

The aims of the economic input into the guideline were to inform the Guideline Development Group (GDG) of potential economic issues relating to urinary incontinence (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 in the original guideline document, with cross references from the relevant chapters:

• Appendix D: Economic evidence for urodynamics
• Appendix E: Costing first-line conservative treatment for urinary incontinence
• Appendix F: Cost effectiveness analysis for duloxetine
• Appendix G: A partial cost-consequence analysis for surgical treatment options for over active bladder (OAB)

External Peer Review
Internal Peer Review

The guideline was validated through two consultations.

1. The first draft of the guideline (The full guideline, National Institute for Clinical Excellence (NICE) guideline and Quick Reference Guide) were consulted with Stakeholders and comments were considered by the Guideline Development Group (GDG).
2. The final consultation draft of the Full guideline, the NICE guideline and the Information for the Public were submitted to stakeholders for final comments.

The final draft was submitted to the Guideline Review Panel for review prior to publication.

A clinical algorithm for the management of urinary incontinence in women is provided in the original full-length guideline document.

There following algorithms are available in the NICE version of the guideline (see "Availability of Companion Documents" field in this summary.)

• Women with UI or OAB
• Stress UI
• OAB with or without Urge UI

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Accurate diagnosis and appropriate management of patients with urinary incontinence (UI) and overactive bladder, prevention of complications of surgical procedures for UI, and improved quality of life

• Adverse effects of antimuscarinic drugs and catheterisation
• Surgical complications

• While every effort has been made to ensure the accuracy of the information contained within this publication, the publisher can give no guarantee for information about drug dosage and application there of contained in this book. In every individual case the respective user must check current indications and accuracy by consulting other pharmaceutical literature and following the guidelines laid down by the manufacturers of specific products and the relevant authorities in the country in which they are practising.
• This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. The guidance does not, however, override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

Implementation

The Healthcare Commission assesses the performance of National Health Service (NHS) organisations in meeting core and developmental standards set by the Department of Health in 'Standards for better health' issued in July 2004. Implementation of clinical guidelines forms part of the developmental standard D2. Core standard C5 says that national agreed guidance should be taken into account when NHS organisations are planning and delivering care.

Key Priorities for Implementation

Assessment and Investigation

• At the initial clinical assessment, the woman's urinary incontinence (UI) should be categorised as stress UI, mixed UI, or urge UI/overactive bladder syndrome (OAB). Initial treatment should be started on this basis. In mixed UI, treatment should be directed towards the predominant symptom.

  Expert opinion concludes that symptomatic categorisation of UI based on reports from the woman and history taking is sufficiently reliable to inform initial, non-invasive treatment decisions.

• Bladder diaries should be used in the initial assessment of women with UI or OAB. Women should be encouraged to complete a minimum of 3 days of the diary covering variations in their usual activities, such as both working and leisure days.

  Bladder diaries are a reliable method of quantifying urinary frequency and incontinence episodes. The Guideline Development Group (GDG) concluded that a 3-day period allows variation in day-to-day activities to be captured while securing reasonable compliance.

• The use of multi-channel cystometry, ambulatory urodynamics or videourodynamics is not recommended before starting conservative treatment.
• For the small group of women with a clearly defined clinical diagnosis of pure stress UI, the of multi-channel cystometry is not routinely recommended.
• Multi-channel filling and voiding cystometry is recommended in women before surgery for UI if:
  • There is clinical suspicion of detrusor overactivity.
  • There has been previous surgery for stress incontinence or anterior compartment prolapse.
  • There are symptoms suggestive of voiding dysfunction.

  Ambulatory urodynamics or videourodynamics may also be considered in these circumstances.

  It has not been shown that carrying out urodynamic investigations before initial treatment improves outcome. Complex reconstructive urological procedures were developed for use in specific urodynamic abnormalities. Hence, the GDG concluded that urodynamic investigations should be used to demonstrate the presence of specific abnormalities before undertaking these procedures. The GDG considered that urodynamic investigations are also of value if the clinical diagnosis is unclear prior to surgery or if initial surgical treatment has failed.

• A trial of supervised pelvic floor muscle training of at least 3 months' duration should be offered as first-line treatment to women with stress or mixed UI.

  There is good evidence that daily pelvic floor muscle training continued for 3 months is a safe and effective treatment for stress and mixed UI.

• Bladder training lasting for a minimum of 6 weeks should be offered as first-line treatment to women with urge or mixed UI.

  There is good evidence that bladder training is an effective treatment for urge or mixed UI, with fewer adverse effects and lower relapse rates than treatment with antimuscarinic drugs.

• Immediate release non-proprietary oxybutynin should be offered to women with OAB or mixed UI as first-line drug treatment if bladder training has been ineffective. If immediate release oxybutynin is not well tolerated, darifenacin, solifenacin, tolterodine, trospium, or an extended release or transdermal formulation of oxybutynin should be considered as alternatives. Women should be counselled about the adverse effects of antimuscarinic drugs.

  There is no evidence of a clinically important difference in efficacy between antimuscarinic drugs. However, immediate release non-proprietary oxybutynin is the most cost effective of the available options.

• Pelvic floor muscle training should be offered to women in their first pregnancy as a preventive strategy for UI.

  There is evidence that pelvic floor muscle training used during a first pregnancy reduces the likelihood of postnatal UI.

• Sacral nerve stimulation is recommended for the treatment of UI due to detrusor overactivity in women who have not responded to conservative treatments. Women should be offered sacral nerve stimulation on the basis of their response to preliminary percutaneous nerve evaluation. Life-long follow-up is recommended.

  The treatment options for women who have detrusor overactivity and have not responded to conservative therapy are all costly and associated with significant morbidity. There is a stronger body of evidence for the effectiveness of sacral nerve stimulation than for other procedures. Up to two-thirds of patients achieve continence or substantial improvement in symptoms after this treatment.

• Retropubic mid-urethral tape procedures using a 'bottom-up' approach with macroporous (type 1) polypropylene meshes are recommended as treatment options for stress UI where conservative management has failed. Open colposuspension and autologous rectus fascial sling are the recommended alternatives when clinically appropriate.

  Many procedures have been described for the treatment of stress UI; although there is no strong evidence of superior effectiveness of any one, the best available data support the use of retropubic mid-urethral tape procedures, colposuspension and autologous rectus fascial sling. Retropubic mid-urethral tape procedures consume fewer hospital resources and are associated with faster recovery than the other two procedures.

• Surgery for UI should be undertaken only by surgeons who have received appropriate training in the management of UI and associated disorders or who work within a multidisciplinary team with this training, and who regularly carry out surgery for UI in women.

  The expertise of the surgeon is one of the factors that influence surgical outcomes. The best outcomes are achieved when surgeons and/or their multidisciplinary team have specialist training and regular practice in continence surgery.

A plan for implementation is described in the companion document Urinary Incontinence in Women, Implementation Advice. (See the "Availability of Companion Documents" field.)

Getting Better
Living with Illness

Effectiveness
Patient-centeredness

• National Collaborating Centre for Women's and Children's Health. Urinary incontinence: the management of urinary incontinence in women. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2006 Oct. 221 p. [960 references]

Not applicable: The guideline was not adapted from another source.

2006 Oct

National Collaborating Centre for Women's and Children's Health - National Government Agency [Non-U.S.]

National Institute for Health and Clinical Excellence (NICE)

Guideline Development Group

Group Members: Elisabeth Adams, Subspecialist in Urogynaecology; Alison Bardsley, Continence Adviser/Service Manager; Linda Crumlin, Patient/Carer Representative; Ian Currie, Consultant Gynaecologist (with an interest in urogynaecology); Lynda Evans, Patient/Carer Representative; Jeanette Haslam, Women's Health Physiotherapist; Paul Hilton, Consultant Gynaecologist and Urogynaecologist (GDG Leader); Margaret Jones, General Practitioner; Malcolm Lucas, Consultant Urological Surgeon; Julian Spinks, General Practitioner; Joanne Townsend, Urogynaecology Nurse Specialist; Adrian Wagg, Consultant Geriatrician

National Collaborating Centre for Women's and Children's Health (NCC-WCH) Staff: Martin Dougherty, Executive Director; Beti Wyn Evans, Research Fellow; Paul Jacklin, Senior Health Economist; Irene Kwan, Research Fellow; Debbie Pledge, Information Specialist; Samantha Vahidi, Work Programme Co-ordinator

Declarations of interest are shown in Appendix A of the original full-length guideline document.

This is the current release of the guideline.

Clinical guidelines commissioned by National Institute for Health and Clinical Excellence (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.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.