Quality of Life

UI imposes a significant psychosocial impact on individuals, their families, and caregivers. UI results in a loss of self-esteem and a decrease in ability to maintain an independent lifestyle. Dependence on caregivers for activities of daily life increases as incontinence worsens. Consequently, excursions outside the home, social interaction with friends and family, and sexual activity may be restricted or avoided entirely (Grimby, Milsom, Molander, et al., 1993; Harris, 1986; Noelker, 1987). Quality-of-life and symptom distress questionnaires for women with UI have been validated for use (Shumaker, Wyman, Uebersax, et al., 1994; Uebersax, Wyman, Shumaker, et al., 1995).

Underreporting/Undertreatment

Fewer than half of individuals with UI living in the community consult health care providers about the problem (Burgio, Ives, Locher, et al., 1994). The reasons for this could be the availability of absorbent products, low expectations of benefit from reporting the condition to health care providers, and lack of information regarding management options. There is a lack of understanding about UI, especially among men, those age 85 or older, and those with lower levels of education Branch, Walker, Wetle, et al., 1994).

Studies show significant variation in performance of adequate examination, assessment, and management of UI. UI is often undetected and underreported by hospital and nursing home personnel, masking its true extent and clinical impact and reducing the opportunity for effective management. Assessment tools with cue words for continence status significantly improve identification of UI in nursing homes and increase the opportunity for effective management (Palmer, McCormick, Langford, et al., 1992).

1992 Guideline

The original UI guideline panel defined UI as involuntary loss of urine that is sufficient to be a problem. The panel agreed that the guideline, which sought to improve the care of incontinent adults, should be directed toward acquired incontinence in ambulatory and nonambulatory patients in outpatient, inpatient, home care, and long-term care settings. Extraurethral UI, which is involuntary loss of urine through channels other than the urethra, was not addressed in the document. The guideline was targeted to all practitioners who encounter UI, with the primary outcome of elimination or reduction of UI.

The original panel also agreed on the components of the evaluation and management of UI, which were considered to be the management model for the guideline. The original guideline made seven broad-based recommendations, as follows:

1. Improve the education and dissemination of UI diagnosis and treatment alternatives to the public and to health care providers.
2. Educate the consumer to report incontinence problems once they occur.
3. Improve the detection and documentation of UI through better medical histories and health care recordkeeping.
4. Establish appropriate basic evaluation and criteria for further evaluation.
5. Delineate the steps of appropriate management.
6. Where appropriate, reduce variations among health care providers, while maintaining flexibility to individualize treatment to individual patients.
7. Encourage further biomedical and clinical research on prevention, diagnosis, and treatment of UI in adults and encourage further research into the costs of UI diagnosis and treatment and the cost benefit of prevention programs.

The original panel conducted an extensive literature review on UI in adults, heard public testimony at a national hearing, and reviewed information from consultants. It also sought further evidence of the costs of UI, variations in practice and payments, the prevalence of incontinence in hospitals, and the incidence of UI in outpatient, rehabilitation, and home settings. Previous research data and expert opinions helped to provide insight into the problem within communities, acute care facilities, and nursing homes. The draft guideline was also extensively peer-reviewed by individual experts and representatives of the various professional and public organizations, and many of their recommendations were incorporated into the document.

The panel found evidence that treatment of UI is effective in most people; however, the condition was underreported, services were improperly or poorly documented, and major variations in diagnosis and treatment were identified as significant problems.

The original UI panel also recommended that review of the guideline respond to new developments in UI research, training, product developments, practice, and patient participation. Because of the magnitude of literature produced each year, the panel recommended that the guideline be updated annually.

Updating the Guideline

Because the recommendations were so broad-based, AHCPR recommended updating the guideline to include recent literature and to provide specific recommendations for managing UI in adults. AHCPR provided the general parameters for this update of the guideline. An update can be in the form of amendments to the guideline or a more complete update and reprinting. In the months following release of a guideline, the Office of the Forum surveys subsequently published scientific literature in the topic areas addressed by the guideline to determine the volume of new scientific evidence, its quality, and the likelihood that such information would cause a change in the guideline recommendations. Comments are also solicited from the public regarding the availability of new scientific evidence or new technologies that may warrant an update. Other relevant information may be obtained from evaluation studies conducted to examine the implementation or effects of the guidelines. When sufficient data are obtained to indicate that a guideline update may be needed, a public meeting to address the need for and timing of an update is convened.

After reviewing and analyzing the findings from the update literature review and analysis since 1992, the Office of the Forum recommended a complete update and reprinting of the guideline. The primary goals of the update process were to present new developments in UI research that affect diagnosis and management of the condition and to develop specific recommendations for each assessment and treatment method. The algorithm for management of UI in primary care was revised to reflect the findings and recommendations of the panel (see Attachment A).

Formation of the Panel

AHCPR initiated formation of the update panel and appointed its chairperson and members. A notice published in the Federal Register invited nominations of new candidates to replace the departing panel members. The original panel chairs reviewed nominations received by AHCPR and provided their recommendations to AHCPR to replace departing members. Following these recommendations, AHCPR selected and appointed the replacement members for the update period. The update panel comprised 16 members representing the multidisciplinary areas included in the original panel -- the departing cochairs were replaced by two of the original panel members, six other original members remained, and eight new members joined. Several consultants with expertise in nursing and primary care, methodology, literature review and analysis, and cost analysis, as well as a representative of the Centers for Disease Control and Prevention (CDC), were appointed to the panel. Over the course of the update process the panel also sought the advice and assistance of 22 technical specialists to evaluate the literature and develop revisions to the original guideline.

Public Comment and Peer Review

An open forum was held September 20, 1993, to give interested individuals, organizations, and agencies the opportunity to present written or verbal testimony. Later in the process, drafts of the revised guideline were sent out for peer review. AHCPR selected peer reviewers from those who had expressed interest in the guideline, participated in the open forum, or were nominated by professional organizations or panel members. The 22 technical specialists were included among the peer reviewers. The reviewers were asked to evaluate the comprehensiveness of the literature review as well as the panel's findings and recommendations. The panel incorporated their comments into the final revision of the guideline.

Literature Search

The panel initiated a comprehensive literature search of topics relating to adult UI. The bibliography from the original guideline was the starting point for this literature search.

The search for literature published since the final literature search conducted for the 1992 guideline was performed through the National Library of Medicine. Over the course of the update process, three searches were conducted. Abstracts of approximately 1,500 articles that met the search criteria were each independently evaluated by panel members for scientific quality and relevance to the guideline update. Approximately 1,200 articles were obtained for further evaluation.

Additional articles came from panel members, from the open forum process, and from unsolicited sources. All articles were entered into a comprehensive bibliography, classified by topic, and screened systematically to determine if they contained information of use to the update panel.

Literature Review and Data Abstraction

The articles were categorized and assigned to corresponding subcommittees for screening and further review. These categories were prevalence, prevention, and quality of life; cost; causes and diagnostic evaluation; behavioral treatment; pharmacological treatment; surgery; supportive devices; and professional and public education. The methodology to identify and evaluate the scientific evidence on each assessment and treatment method included a systematic evaluation of each study's quality and its applicability to adult patients with UI. The panel screened all articles, using minimum article selection criteria to select articles for data abstraction. The panel subcommittees used a common data abstraction method, but because of the varied nature of the subject, each subcommittee determined its own inclusion/exclusion criteria. The pharmacology subcommittee restricted review to clinical efficacy studies of drugs likely to be available in the United States. Because few such studies exist in other areas, it was not possible to place similar restrictions on the review of behavioral and surgical interventions. Minimum criteria generally required that articles represent a designed study (not a case report) with outcome defined in some manner. The articles selected were then sent to technical specialists for review for data abstraction and for confirmation of the data abstraction process. The technical specialists followed the same data abstraction process to evaluate the quality and to abstract pertinent data from each article. The articles on behavioral, pharmacologic, and surgical treatments were further reviewed and summaries of results (with total number of subjects and a range or average of improvement or success rates) provided. The papers on diagnostic, supportive, and health education were not judged applicable for meta-analysis.The panel then reviewed the available data to decide how much weight to give each study in developing the recommendation statements for the update guideline.

Outcome Measures

The panel was aware of the limits of and issues surrounding current outcome measures while evaluating the available data on assessment and treatment methods for UI. The current outcome measure of UI treatment is to stop urine leakage or to reduce its amount, frequency, or both. Measuring urine leakage or wetting is difficult, however. The panel agreed that UI outcome can be measured in many domains (e.g., patients' opinions, diaries, pad tests, quality-of-life scales, urodynamic tests) and that each of these domains is continuous and not discrete. The International Continence Society and other groups are considering standardization of outcome measures.

The wide variability in outcomes measured in different articles made it difficult to choose a single outcome measure to assess treatment. Because the subjective outcome of "cure," improvement, or both was cited in studies much more often than objective measures, this was the outcome the panel generally relied on. When sufficient articles presented results on incontinent episodes, these were also noted.

Developing the Guideline Recommendations

To develop recommendations for each assessment and treatment method, the panel considered (1) the quality and amount of evidence, (2) the consistency of findings among studies, (3) the clinical applicability of the evidence to adult patients with UI, and (4) the evidence on harms or costs.

Specific recommendation statements were developed by the panel collectively. The panel rated the strength of evidence supporting each recommendation, based on the following criteria:

• A.
• The recommendation is supported by scientific evidence from properly designed and implemented controlled trials providing statistical results that consistently support the guideline statement.
• B.
• The recommendation is supported by scientific evidence from properly designed and implemented clinical series that support the guideline statement.
• C.
• The recommendation is supported by expert opinion.

Please note that these ratings represent the strength of the supporting research evidence, not the strength of the recommendation itself. The strength of each recommendation is conveyed in the language describing it.