A new clinical guideline from the Women's Preventive Services Initiative (WPSI) recommends annual screening all women, even adolescents, for urinary incontinence, but editorialists say this recommendation is premature and relies on insufficient evidence. "Although minimum screening intervals are unknown, given the prevalence of urinary incontinence, that many women do not volunteer symptoms, and the multiple, frequently changing risk factors associated with incontinence, annual testing is reasonable," the authors write. "[A[lthough increasing parity, advancing age, and obesity are associated with an increased risk for urinary incontinence, these factors should not be used to limit screening," they add. Nancy O'Reilly, MHS, from the American College of Obstetricians and Gynecologists, Washington, DC, and colleagues published the clinical guideline online today in Annals of Internal Medicine on behalf of the WPSI. Screening should address symptoms, including the type and degree of incontinence, as well as whether those symptoms affect the woman's activities and quality of life, the authors explain. In an accompanying editorial, Robin J. Bell, MBBS, PhD, MPH, and Susan R. Davis, MBBS, PhD, both from Monash University, Melbourne, Victoria, Australia, question the value of screening questionnaires currently in use. "Although questionnaires are available to identify urinary incontinence in women, the systematic review accompanying the WPSI recommendation found limited evidence to support their diagnostic accuracy in the community," they write. "The same review reports that no trials have examined the benefits and harms of urinary incontinence screening. Nonetheless, the WPSI argues that we should not wait for direct evidence and bases its recommendation on a chain of indirect evidence." In fact, the literature review the editorialists refer to, also published in the journal today, showed insufficient evidence on the overall effectiveness or harms of screening. And none of the included studies evaluated the effectiveness of screening to reduce adverse effects or harms. "In the absence of direct evidence of the benefits and harms of screening, the WPSI based its recommendation on the high prevalence of urinary incontinence in women; its effect on health, quality of life, and function; and indirect evidence on the accuracy of tests that may be used for screening in primary care," O'Reilly and colleagues explain in the guideline. The authors identified 17 studies that evaluated the diagnostic accuracy of 18 screening questionnaires when compared with a clinical diagnosis or diagnostic test results. The studies included between 69 and 1911 participants from primary care, gynecology, or urogynecology clinics located in the United States, United Kingdom, Denmark, Austria, Norway, Finland, and Australia. Of the 17 studies, 14 were of poor quality and had limitations, including being based in referral clinics or enrolling only symptomatic women. Twelve of these included women with incontinence and may not be pertinent to a screening population. "Most studies enrolled participants who had incontinence symptoms, although 5 studies of 6 methods did not and are most relevant to screening," the authors note. One good-quality and two fair-quality studies evaluated four screening methods in women who were not symptomatic. In these studies, areas under the receiver-operating characteristic curve for stress, urge, and any type of incontinence were 0.79, 0.88, and 0.88 for the Michigan Incontinence Symptom Index; 0.85, 0.83, and 0.87 for the Bladder Control Self-Assessment Questionnaire; and 0.68, 0.82, and 0.75 for the Overactive Bladder Awareness Tool. Sensitivity and specificity for any type of incontinence were 66% and 80%, respectively, for the Incontinence Screening Questionnaire. In the editorial, Bell and Davis challenge the wisdom of trusting inadequate data. "We must learn from experience in women's health, in which faith in indirect evidence often proved naive when direct evidence became available. A randomized trial of ovarian cancer screening with ultrasonography and CA-125 levels showed that more women in the screened group were given a diagnosis of cancer and received treatment, with no reduction in mortality but with many more complications," they write. Instead, researchers should conduct a randomized trial that directly evaluates the benefits and harms of screening women for urinary incontinence, they say. "This trial should be designed to assess the benefit–harm balance for screening at different life stages (from adolescence to old age) and to identify high-risk groups, such as women with comorbid pelvic floor conditions, for whom the benefits of screening might outweigh the risks." Designing such a study would be challenging because researchers would first need to agree on a specific screening tool, and most existing questionnaires apply to symptomatic women and not the general population. For this reason, these questionnaires would likely result in many false-positive results and cause many women to undergo unnecessary diagnostic and invasive testing. "If screening were associated with even a small amount of harm and the proportion of women who would benefit from early identification were modest, then the net benefit might be marginal or negative. Therefore, we advocate caution in implementing the WPSI recommendation until there is direct evidence for a net benefit of annual screening for urinary incontinence," Bell and Davis conclude. Source
