NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE 1 Guideline title SCOPE Urinary incontinence: the management of urinary incontinence in women 1.1 Short title Urinary incontinence 2 Background a) The National Institute for Clinical Excellence ( NICE or the Institute ) has commissioned the National Collaborating Centre for Women s and Children s Health to develop a clinical guideline on urinary incontinence for use in the NHS in England and Wales. This follows referral of the topic by the Department of Health and Welsh Assembly Government (see Appendix). The guideline will provide recommendations for good practice that are based on the best available evidence of clinical and cost effectiveness. b) The Institute s clinical guidelines will support the implementation of National Service Frameworks (NSFs) in those aspects of care where a Framework has been published. The statements in each NSF reflect the evidence that was used at the time the Framework was prepared. The clinical guidelines and technology appraisals published by the Institute after an NSF has been issued will have the effect of updating the Framework. 3 Clinical need for the guideline a) Urinary incontinence is common. Estimates of the prevalence in women range from 10 52%, and this prevalence increases with age. The wide range is due to variations in the definitions of incontinence used, the populations sampled, and the methods of data collection. Page 1 of 8
b) Urinary incontinence is defined as any involuntary leakage of urine and in women it commonly exists with other pelvic floor pathologies including pelvic organ prolapse. Urinary incontinence can cause embarrassment and can impact on daily activities and quality of life. It can lead to depression, loss of confidence, loss of self-esteem and can carry considerable social and economic costs. c) There are several types of urinary incontinence. The most widespread type in women is stress urinary incontinence which is involuntary leakage on effort or exertion, or on sneezing or coughing. Factors that contribute to the development of stress incontinence include pregnancy and vaginal delivery, obesity, and cigarette smoking. Urge incontinence is involuntary leakage accompanied by or immediately preceded by urgency. Mixed urinary incontinence is involuntary leakage associated with urgency and also with exertion, effort, sneezing, or coughing. Urgency, with or without urge incontinence and usually with frequency and nocturia, can be described as overactive bladder syndrome, urge syndrome, or urgency-frequency syndrome. d) Diagnosis of urinary incontinence is usually based on symptoms, examination, and exclusion of underlying causes or co-morbidity (e.g. urinary tract infection). Objective assessment of pad tests and urodynamic tests to measure bladder and urethral functioning may also be used. e) Treatment depends on the type of urinary incontinence (stress, mixed or urge), or overactive bladder syndrome. The majority of women are treated in primary care using conservative approaches. These include lifestyle modifications, physical therapies such as exercises to strengthen the pelvic floor muscles (with or without the aid of tools such as biofeedback), neuromuscular electrical stimulation, behavioural interventions, and pharmacotherapy. Surgery is offered if non-surgical treatment has failed or is unsuitable, but is associated with a range of potential complications. Page 2 of 8
f) Between 2002 and 2003, about 10,000 bladder-outlet operations were performed on females in England. Various surgical techniques are used for the treatment of stress incontinence and include: colposuspension; suburethral sling procedures (traditional or minimally invasive); anterior repair; and the placement of bulking materials (pastes or balloons) transurethrally or periurethrally. Surgical treatments for urge incontinence include sacral-nerve stimulation and augmentation cystoplasty. g) The effectiveness of treatments for urinary incontinence is primarily evaluated by: improvement in quality of life, social functioning, subjective reduction in urine leakage, objective reduction in urine leakage on urodynamic testing, and pad tests. 4 The guideline a) The guideline development process is described in detail in two publications which are available from the NICE website (see Further information ). The guideline development process an overview for stakeholders, the public and the NHS describes how organisations can become involved in the development of a guideline. Guideline development methods information for National Collaborating Centres and guideline developers provides advice on the technical aspects of guideline development. b) This document is the scope. It defines exactly what this guideline will (and will not) examine, and what the guideline developers will consider. The scope is based on the referral from the Department of Health and Welsh Assembly Government (see Appendix). c) The areas that will be addressed by the guideline are described in the following sections. Page 3 of 8
4.1 Population 4.1.1 Groups that will be covered a) Women who have urinary incontinence (overactive bladder, stress or mixed incontinence). Women with overactive bladder, wet or dry, will be included. No upper age limit will be applied to the population for this guideline and, where the evidence supports it, different age groups will be considered. 4.1.2 Groups that will not be covered a) The management and treatment of co-morbidities, such as pelvic organ prolapse, will be covered where they relate to the treatment of urinary incontinence and /or overactive bladder syndrome, but not beyond this. b) Incontinence in association with neurological disease. c) Incontinence in children. d) Incontinence in men. e) Anal (faecal / flatal) incontinence. 4.2 Healthcare setting a) The guideline will cover the care that is provided by primary, secondary and tertiary healthcare professionals who are involved in the care of the population covered. 4.3 Clinical management a) The guideline will cover the assessment and investigation, medical and surgical management, use of other healthcare interventions for incontinence, and containment in women through all stages of their care. This will include the following areas (sections 4.3b d). Page 4 of 8
b) Assessment and investigation the guideline will provide advice on appropriate initial and ongoing assessment, including advice on investigations. c) The guideline will provide information on the appropriate use of treatment options including conservative techniques (lifestyle modifications, behavioural interventions, physical therapies, and containment), pharmacotherapy, and surgical options (including colposuspension; suburethral sling procedures [traditional or minimally invasive]; anterior repair; use of bulking materials; sacral-nerve stimulation; augmentation cystoplasty). The guideline will also provide information on the prophylactic use of conservative techniques. d) The guideline will define the competencies required by surgeons performing the primary and subsequent operative procedures. e) Advice on treatment options will be based on the best evidence available to the Guideline Development Group. When referring to pharmacological interventions, the guideline will normally recommend use within the licensed indications. Exceptionally, and only where the evidence clearly supports it, the guideline may recommend use of a pharmacological intervention beyond its licensed indications. The guideline recommendations will assume that prescribers will use the Summary of Product Characteristics to inform their prescribing decisions for individual patients. 4.4 Status 4.4.1 Scope This is the final scope. 4.4.2 Guideline The development of the guideline recommendations will begin in January 2005. Page 5 of 8
5 Further information Information on the guideline development process is provided in: The guideline development process an overview for stakeholders, the public and the NHS Guideline development methods information for National Collaborating Centres and guideline developers These booklets are available as PDF files from the NICE website (www.nice.org.uk). Information on the progress of the guideline will also be available from the website. 6 Related NICE guidance 6.1 Clinical Guidelines Intrapartum care: management and delivery of care to women in labour. (Clinical Guideline in development.) Post natal care: routine post natal care of recently delivered women and their babies. (Clinical Guideline in development.) 6.2 Technology Appraisals The following Technology Appraisal will be updated within this guideline and withdrawn once the guideline is published: Guidance on the use of tension-free vaginal tape (Gynecare TVT) for stress incontinence. Technology Appraisal Guidance No. 56 (2003). 6.3 Interventional Procedures Sacral nerve stimulation for urge incontinence and urgencyfrequency. Interventional Procedure Guidance No. 64 (2004). Bone-anchored cystourethropexy (using data from In-Tac and Vesica as specified by SERNIP). Interventional Procedure Guidance No. 18 (2003). Page 6 of 8
Transobturator foramen procedures for stress urinary incontinence. Interventional procedure in development. Posterior infracoccygeal sacropexy for vaginal vault prolapse. Interventional procedure in development Biological slings for stress urinary incontinence. Interventional procedure in development. Adjustable intramural urethral implants for stress urinary incontinence. Interventional procedure in development. Intramural urethral bulking for stress urinary incontinence. Interventional procedure in development. The published guidelines or updates on progress for guidelines in development are available as PDF files from the NICE website (www.nice.org.uk). Page 7 of 8
Appendix Referral from the Department of Health and Welsh Assembly Government The Department of Health and Welsh Assembly Government asked the Institute: To prepare clinical guidelines for the NHS in England and Wales for the management of urinary incontinence and prolapse of the womb. The guideline should cover both stress incontinence and incontinence due to detrusor instability (overactive bladder muscle). The guideline should: ascertain which treatments, medical and surgical, are effective describe the criteria to be used to determine which patients should be selected for surgery define the competencies required by surgeons performing the primary and any subsequent operative procedures. Page 8 of 8