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Validation of a Two-Item Quantitative Questionnaire for the Triage of Women With Urinary Incontinence

From the ¹Greater Baltimore Medical Center, Baltimore, Maryland; ²University of Miami, Miami, Florida; ³Wayne State University, Detroit, Michigan; ⁴Washington University School of Medicine, St. Louis, Missouri; ⁵Princess Anne Hospital, Southampton, United Kingdom; ⁶University of Manitoba, Winnipeg, Canada; and ⁷Lilly Research Laboratories, Indianapolis, Indiana.

	ABSTRACT

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
OBJECTIVE: To evaluate the reproducibility, construct validity, and preferences for the 2-item Stress/Urge Incontinence Questionnaire.

METHODS: The questionnaire asks a patient to recall the number of stress urinary incontinence and urge urinary incontinence episodes she experienced during the preceding week. The 4-week prospective study included 3 office visits and enrolled women with stress, urge, or mixed urinary incontinence symptoms. The test–retest reproducibility was assessed after 3 days, and the construct validity of the questionnaire was evaluated against a diary and other measures of incontinence severity and effect. The bother associated with completing (patients) or analyzing (physicians) the diary was assessed. Both groups also reported their time requirements and preferences for the questionnaire or diary.

RESULTS: Reproducibility for the classification of symptoms was moderately strong ( = .536). Test–retest agreement was good (64–80%) for all but balanced mixed incontinence (38%). Intraclass correlations revealed good reproducibility for the number of stress (.694), urge (.703), and total (.726) incontinence episodes. Significant (P < .01) correlations with other measures of incontinence established construct validity. Patients and physicians reported it took less time to complete the questionnaire than the diary, but the majority said the completion or analysis of the diary was of little or no bother and preferred the diary.

CONCLUSION: The Stress/Urge Incontinence Questionnaire is a valid tool that can be used in clinical practice to differentiate between symptoms of stress and urge urinary incontinence to make an initial diagnosis, especially in primary care where incontinence is not a focus of the practice.

LEVEL OF EVIDENCE: III

Primary care physicians and general gynecologists often provide the initial diagnosis and treatment for women with urinary incontinence. Unfortunately many primary care physicians do not feel adequately prepared to properly evaluate and manage women with urinary incontinence and often do not ask women whether they have experienced urine leakage.^3,4 The categorization of incontinence symptoms, as recommended by the International Consultation on Incontinence, is key in the assessment of women with incontinence.⁵ Urinary diaries are valid and reproducible,⁶ but there is concern that patients and physicians find diaries inconvenient and could delay a diagnosis. A validated tool that provides immediate results would be a valuable option for clinicians who need a simple, quick assessment instrument.

A 2-item tool, 1 question for stress urinary incontinence and 1 for urge urinary incontinence has been suggested.⁷ The objectives of this study were to evaluate the test–retest reproducibility and the construct validity of a 2-item Stress/Urge Incontinence Questionnaire in a large clinical trial. An additional aim was to assess participants' and physicians' preferences for the Stress/Urge Incontinence Questionnaire compared with a 1-week paper urinary diary.

	MATERIALS AND METHODS

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Women aged 18 years and older who reported an average of at least 4 incontinence episodes per week were enrolled in the study from October 2003 to May 2004. Participants, who were either recruited by the study investigators or responded to advertisements for the study, were eligible at the completion of this study to enter a double-blind, randomized trial of an investigational pharmacologic treatment for urinary incontinence. The incontinence symptoms could include only stress urinary incontinence, only urge urinary incontinence, or a combination of both (mixed urinary incontinence) and must have been present for a minimum of 3 months before study entry. To include participants who might typically see a primary care provider for treatment of incontinence, participants could not have received treatment for incontinence by a continence expert within the past 5 years. Prior surgery, including correction of incontinence, was allowed if the procedure was completed 6 months before a subject entered the study. Participants who performed pelvic floor muscle training could not initiate or change their regimen within 3 months before study entry or during the study. Written informed consent was obtained from all participants before enrollment and each study site's ethical review board approved the protocol. The principal investigators included 33 urologists, 23 gynecologists, and 7 primary care physicians.

The 4-week study period included 3 office visits (Fig. 1). The Stress/Urge Incontinence Questionnaire (box), which asks the patient to recall the number of stress urinary incontinence and urge urinary incontinence episodes she experienced over the preceding week using standard, understandable descriptions of stress urinary incontinence and urge urinary incontinence episodes, was administered at all 3 visits. Patients also completed the Stress/Urge Incontinence Questionnaire at home 3 days after Visit 1. The questionnaire responses at Visit 1 were used to classify participants as having symptoms of pure stress urinary incontinence, stress predominant mixed urinary incontinence, balanced mixed urinary incontinence, urge predominant mixed urinary incontinence, or pure urge urinary incontinence (box).

View larger version (13K): [in this window] [in a new window]   Fig. 1. Study design and the timing of administering the Stress/Urge Incontinence Questionnaire and tools used to validate the Stress/Urge Incontinence Questionnaire. S/UIQ, Stress/Urge Incontinence Questionnaire; ICIQ-SF, International Consultation on Incontinence Questionnaire Short Form; I-QOL, Incontinence Quality of Life questionnaire; PGI-S, Patient Global Impression of Severity rating; PGI-B, Patient Global Impression of Bother rating. Bent. Stress/Urge Incontinence Questionnaire. Obstet Gynecol 2005.

View larger version (50K): [in this window] [in a new window]

A 1-week paper diary was completed before Visit 2. The paper diary asks the participant to record the time of voids and incontinence episodes in each day and the subtype of the incontinence episodes (stress or urge symptoms). The collection of the paper diary allowed for participants and investigators to evaluate the Stress/Urge Incontinence Questionnaire compared with a standard method of assessing incontinence symptoms. Paper diaries have proved to be highly reproducible on test–retest analysis with incontinent women enrolled in a clinical trial for treatment of urinary incontinence independent of the physiologic subtype of their incontinence (r = .86 to .91).⁶

Also at Visit 2, a questionnaire asked participants to recall how much time was required to complete the paper diary and Stress/Urge Incontinence Questionnaire in addition to how much bother was associated with completing the diary (http://greenjournal.org/cgi/content/full/106/4/767/DC1). A similar questionnaire was completed by the physicians regarding the analysis of the diary and Stress/Urge Incontinence Questionnaire results (http://greenjournal.org/cgi/content/full/106/4/767/DC2). Both participants and physicians also rated their preference for the Stress/Urge Incontinence Questionnaire or diary.

A 2-week electronic diary (e-diary) was completed between Visit 2 and Visit 3. The e-diary recorded similar data to the paper diary. Participants entered the time of voids and stress or urge incontinence episodes. The stress, urge, and total (stress and urge) Incontinence Episode Frequency, which is the count of the number of incontinence episodes, is obtained from the subject diaries. The last 7 days of data from the e-diaries are used to directly compare the Incontinence Episode Frequency results recorded in the diary to the results from the Stress/Urge Incontinence Questionnaire. The e-diaries included a data lock-out system to encourage real-time data collection and to prevent participants from reviewing diary records before completing the Stress/Urge Incontinence Questionnaire, thus providing a better separation of the 2 measurements. The e-diary is expected to have similar reproducibility and validity as a paper diary because both tools ask the same types of questions.

Several additional tools, intended to provide supplementary data to assess the construct validity of the Stress/Urge Incontinence Questionnaire, were administered at visit 3. First, the International Consultation on Incontinence Questionnaire Short Form is a 4-item questionnaire proposed by the International Consultation on Incontinence.⁸ The International Consultation on Incontinence Questionnaire Short Form items include the frequency, volume, and life effect of incontinence and generates a total score from 0 to 21. A fourth question characterizes the type of incontinence symptoms. The reliability and validity of the International Consultation on Incontinence Questionnaire Short Form questionnaire has been established and reported.⁹ Second, the Incontinence Quality of Life is a 22-item validated, condition-specific, quality of life questionnaire.^10,11 The Incontinence Quality of Life Questionnaire is 1 of the 2 quality-of-life instruments that received the highest ("highly recommended") rating from the International Consultation on Incontinence for condition-specific measures of incontinence effect in men and women.⁸ Third, the Patient Global Impression of Severity Scale consists of a single, validated question¹² that asks patients to self-describe their current urinary tract condition. The 4 possible responses are "Normal," "Mild," "Moderate," and "Severe." Fourth, the Patient Global Impression of Bother is a 1-item questionnaire that asks participants to determine how bothered they are by their incontinence according to 5 categories (0 = "Not at all" to 4 = "Extremely").

The reproducibility of the Stress/Urge Incontinence Questionnaire was evaluated by comparing the first questionnaire (completed at Visit 1) with a second questionnaire completed 3 days later. Both the incontinence symptom subtype and the number of incontinence episodes were assessed for reproducibility. The scores for the incontinence symptom subtype were judged according to a standard method.¹³ For the number of incontinence episodes, the intraclass correlation coefficient was calculated between the 2 sets of results.

The Stress/Urge Incontinence Questionnaire responses were correlated with the results from the diary and other measures of incontinence severity, bother, and effect to establish construct validity. The Spearman correlation coefficient was used to determine the degree of association between the Stress/Urge Incontinence Questionnaire results and the e-diary Incontinence Episode Frequency, International Consultation on Incontinence Questionnaire Short Form, the Incontinence Quality of Life Questionnaire total score, the Patient Global Impression of Severity, and Patient Global Impression of Bother ratings, all determined at Visit 3. All statistical analyses were completed using the Statistical Analysis System v.8 software (SAS Institute, Cary, NC).

	RESULTS

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A total of 723 women participated in the study. Overall, the mean age was 53.6 years (range 19–85 years), and 61.7% of the women were postmenopausal. The mean body mass index was 31.0 kg/m², and most of the participants (87%) were white. Approximately one-sixth (16.6%) of the women currently performed pelvic floor muscle training. Previous continence surgery was reported by 6.8% of the participants.

Reproducibility for the classification of symptom subtypes (Table 1) was moderately strong ( = .536). Test–retest agreement was good for all but balanced mixed urinary incontinence, which was strictly defined as exactly the same number of stress urinary incontinence and urge urinary incontinence episodes (box). For the number of incontinence episodes, intraclass correlations indicated good reproducibility for the stress (.694), urge (.703), and total (.726) incontinence episodes.

Construct validity was established by demonstrating significant (all P < .01) Spearman correlations with the electronic diary (.82), the International Consultation on Incontinence Questionnaire Short Form (.63), the Patient Global Impression of Severity (.40), and the Patient Global Impression of Bother (.25). The Incontinence Quality of Life Questionnaire, in which lower scores represent lower quality of life, was significantly inversely correlated (–.38) with the Stress/Urge Incontinence Questionnaire results, as expected.

Figure 2 summarizes the distribution of incontinence episodes on the e-diary (total Incontinence Episode Frequency, stress Incontinence Episode Frequency, and urge Incontinence Episode Frequency in each mixed incontinence subgroup, with the categories based on the Stress/Urge Incontinence Questionnaire at Visit 1 as described previously). In the stress predominant and urge predominant mixed urinary incontinence subgroups, a substantial proportion of the incontinence episodes were urge and stress, respectively. The proportion of stress and urge episodes in the balanced mixed urinary incontinence group was nearly equal.

View larger version (28K): [in this window] [in a new window]   Fig. 2. Distribution of Incontinence Episode Frequency by Mixed Urinary Incontinence subtype. IEF, Incontinence Episode Frequency. Bent. Stress/Urge Incontinence Questionnaire. Obstet Gynecol 2005.

Assessment of the Stress/Urge Incontinence Questionnaire is reported in Table 2. Participants reported that more time was required to complete the paper diary compared with the Stress/Urge Incontinence Questionnaire. Similarly, the diary required more time for the physicians to evaluate the data compared with the Stress/Urge Incontinence Questionnaire, although the difference was smaller than for the participants' responses. The majority of participants and physicians said the completion or analysis of the diary was of little or no bother and had at least some preference for the diary rather than the Stress/Urge Incontinence Questionnaire.

	DISCUSSION

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
The Stress/Urge Incontinence Questionnaire was reproducible as a baseline measure of incontinence. The construct validity of the Stress/Urge Incontinence Questionnaire was demonstrated by the significant correlations with the diary results and multiple other measures of baseline incontinence severity, bothersomeness, and effect. The moderate correlations of the Stress/Urge Incontinence Questionnaire results with the International Consultation on Incontinence Questionnaire Short Form, Incontinence Quality of Life Questionnaire, Patient Global Impression of Severity, and Patient Global Impression of Bother were expected and indicate that each tool measures a different aspect of a subject's incontinence symptoms or the effect of the condition on a patient's life. The Stress/Urge Incontinence Questionnaire subgroup assignments were authenticated when the e-diary Incontinence Episode Frequency data were compared across the mixed urinary incontinence subgroups (Fig. 2). The e-diary data also documented that the study population did represent a true mixed urinary incontinence population, because all mixed urinary incontinence groups had appreciable proportions of both stress urinary incontinence and urge urinary incontinence. Perhaps surprisingly, the participants and physician investigators were not bothered by the paper diary and preferred it to the Stress/Urge Incontinence Questionnaire even though the diaries required more time to complete and analyze.

The reproducibility of the Stress/Urge Incontinence Questionnaire was similar to a tool tested in an elderly population.¹⁴ In another study, the test–retest reliability of a 6-question (3 urge, 3 stress) instrument resulted in correlations of 0.91 and 0.83 for stress and urge incontinence scores,¹⁵ but this questionnaire used a fixed scale (scoring range of 0 to 5), so the results are not directly comparable to the current study. As expected, the Stress/Urge Incontinence Questionnaire correlation with e-diary Incontinence Episode Frequency was the strongest (.82) of any of the tools used here for validation, because the 2 instruments are recording the same symptoms using different methods. For comparison, a global impression tool such as the Patient Global Impression of Severity had a weaker, but significant, correlation (0.36) with Incontinence Episode Frequency results from a paper diary.¹²

A limitation of the current study is that most of the investigators were incontinence specialists, whereas primary care providers would be more likely to use the Stress/Urge Incontinence Questionnaire in clinical practice. Although the study population was intended to be similar to the typical patients presenting with incontinence to a primary care clinic, the participants in this study might have been more motivated and less bothered to complete the more detailed assessment tools such as the diary. The Stress/Urge Incontinence Questionnaire, while convenient, does not provide some of the information that would be obtained from more detailed tools (eg, urinary diaries) such as the frequency of urination, type and volume of fluid intake, and nocturia. Furthermore, questions about urgency or other lower urinary tract complaints are not included in the Stress/Urge Incontinence Questionnaire.

Due to differences in clinical practice, specialists, compared with primary care physicians, typically spend more time with a patient during an office visit.¹⁶ Most incontinence specialists and their patients might prefer a urinary diary whereas a generalist might prefer the Stress/Urge Incontinence Questionnaire. When time restrictions limit the focus on incontinence assessment and care, the Stress/Urge Incontinence Questionnaire is a validated and time-saving alternative to a urinary diary that can be used to differentiate symptoms of stress urinary incontinence and urge urinary incontinence for an initial diagnosis. Especially as public awareness of the prevalence of incontinence increases and more patients seek treatment, clinicians will need to differentiate stress and urge incontinence symptoms quickly to make initial patient management decisions.

APPENDIX
The Duloxetine Mixed Urinary Incontinence Study Group included the following principal investigators and their staff:

James Bailen, MD, Jeffersonville, IN; Joseph Banno, MD, Urological Associates, Peoria, IL; Barbara Bates, MD, Wenatchee Valley Medical Center, Wenatchee, WA; Alfred Bent, MD, Greater Baltimore Medical Center, Baltimore, MD; Marc Blasser, MD, Urology Associates of Northeast Florida, Orange Park, FL; Stanley Brosman, MD, Pacific Clinical Research, Santa Monica, CA; Charles Butrick, MD, Urogynecology Center, Overland Park, KS; James Capo, MD, Executive Health & Research Associates, Atlanta, GA; David Chaikin, MD, Morristown Memorial Hospital, Morristown, NJ; Lynn Conrad, MD, Urology Center of the South, Germantown, TN; Adnan Dahdul, MD, Future Care Studies, Springfield, MA; Karlotta Davis, MD, MPH, University of Colorado Health Sciences Center, Aurora, CO; Jeffrey Dell, MD, Institute for Female Pelvic Medicine, Knoxville, TN; Ananias Diokno, MD, William Beaumont Hospital, Royal Oak, MI; Renee Edwards, MD, Oregon Health & Science University, Portland, OR; Robert Feldman, MD, Miami Research Associates, Miami, FL; Paul Fine, MD, Baylor College of Medicine, Dept. of Ob/Gyn, Houston, TX; Sheldon Freedman, MD, Clinical Research Solutions, Las Vegas, NV; Steven Gange, MD, Western Urological Clinic, Salt Lake City, UT; Pablo Gomery, MD, Massachusetts General Hospital, Boston, MA; Angelo Gousse, MD, University of Miami School of Medicine, Miami, FL; Christopher Graham, MD, San Antonio, TX; William Gray, MD, Spokane, WA; Marko Gudziak, MD, Michigan Institute of Urology, St. Clair Shores, MI; Richard Harris, MD, RMD Clinical Research Institute, Melrose Park, IL; Susan Hendrix, DO, Wayne State University, Detroit, MI; Nicolette Horbach, MD, Northern Virginia Pelvic Surgery Associates, P.C., Annandale, VA; Ron Israeli, MD, Staten Island Urological Research, PC, Staten Island, NY; J. Daniel Johnson, MD, Harris Methodist Hospital Fort Worth, Fort Worth, TX; Jed Kaminetsky, MD, University Urology Associates, New York, NY; Roy Kaplan, MD, East Bay Clinical Trial Center, Concord, CA; Carl Klutke, MD, Washington University School of Medicine, St. Louis, MO; Peter Kwong, MD, Devine Tidewater Urology, Norfolk, VA; Samuel Lederman, MD, Radiant Research, West Palm Beach, FL; Bruce Levine, MD, Phoenix Ob-Gyn Associates, LLC, Moorestown, NJ; Sean Manion, MD, Longmont Medical Research Network, Longmont, CO; Leonard Marks, MD, Urological Sciences Research Foundation, Culver City, CA; Terry Mason, MD, Prairie Medical Associates, Chicago, IL; Myron Murdock, MD, Greenbelt, MD; Alexander Murray, MD, Greensboro, NC; Richard Myers, MD, Jacksonville Center for Clinical Research, Jacksonville, FL; Eric Rovner, MD, University of Pennsylvania, Philadelphia, PA; Howard Schafer, MD, Arnett Clinic, Lafayette, IN; Michael Scutella, MD, Square One Clinical Research, Erie, PA; Joel Slutsky, MD, Kankakee Urological Associates, Kankakee, IL; Brian Snyder, MD, Southgate Medical Group, West Seneca, NY; Steven Swift, MD, Medical University of South Carolina, Charleston, SC; Michael Valley, MD, Park Nicollet Clinic, Minneapolis, MN; Paul Abrams, MD, Southmead Hospital, Bristol, Avon, United Kingdom; Christopher Chapple, MD, Royal Hallamshire Hospital, Sheffield, South Yorkshire, United Kingdom; Lindsay Morrison, MD, Southern General Hospital, Glasgow, Scotland, United Kingdom; Vikram Khullar, MD, St Mary's Hospital, London, United Kingdom; Douglas Tincello, MD, Leicester General Hospital, Leicester, Leicestershire, United Kingdom; Simon Jackson, MD, John Radcliffe Infirmary, Headington, Oxford, United Kingdom; Ashwani Monga, MD, Princess Anne Hospital, Southampton, United Kingdom; Lawrence Stewart, MD, Western General Hospital, Edinburgh, Scotland, United Kingdom; Robert Freeman, MD, Derriford Hospital, Plymouth, Devon, United Kingdom; Anthony Smith, MD, St. Mary's Hospital For Women And Children, Manchester, United Kingdom; Gerald Brock, MD, St. Joseph's Health Center London, London, Ontario, Canada; Steven Bryniak, MD, St. John, New Brunswick, Canada; Richard Casey, MD, Trafalgar Professional Center, Oakville, Ontario, Canada; Russell Egerdie, MD, Urology Associates, Kitchener, Ontario, Canada; Gary Gray, MD, Edmonton Prostate & Urological Research Center, Edmonton, Alberta, Canada; Gary Steinhoff, MD, Victoria, British Columbia, Canada; Chui Yuen, MD, Manitoba Clinic, Winnipeg, Manitoba, Canada; Joseph Zadra, MD, The Male/Female Health And Research Centre, Barrie, Ontario, Canada

	Footnotes

 
* For members of the Duloxetine Mixed Urinary Incontinence Study Group, see the Appendix.

The authors thank Guangbin Peng for completing statistical analyses.

Presented in part at the 53rd Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, May 9–11, 2005, San Francisco, California.

Corresponding author: Dr. David Muram, Eli Lilly and Company Corporate Center, DC 4109, Indianapolis, Indiana 46285; e-mail: dmuram{at}lilly.com.

Financial Disclosure: Sponsored by Eli Lilly and Company and Boehringer Ingelheim. Drs. Meadows, Yalcin, and Muram are full-time employees of Eli Lilly and Company and hold stock and stock options in the company.

doi:10.1097/01.AOG.0000178168.33249.49

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This Article Abstract Full Text (PDF) Participant Preference Questionnaire Investigator Preference Questionnaire Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Bent, A. E. Search for Related Content PubMed PubMed Citation Articles by Bent, A. E.