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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04016298
Other study ID # Pro00032238
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 31, 2019
Est. completion date May 25, 2022

Study information

Verified date May 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Prevention of Lower Urinary Symptoms (PLUS) Research Consortium is working to optimize prevention of lower urinary tract symptoms (LUTS) in women and adolescent females across their life spans. The ability to measure bladder health and key risk and protective factors is crucial to the PLUS mission. To describe and measure the spectrum of bladder health in diverse populations, researchers need a valid and reliable instrument. To date, the Consortium's work on design of a bladder health instrument has been a culmination of expert opinion, information from focus groups, and incorporation of previously validated items and language where appropriate, along with cognitive interviews of participants from the general public. The next step in the consortium's work is to prospectively collect data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that can assess the full range of bladder health of women. This will be through a combination of general population recruitment for completing mailed surveys, clinical population recruitment for completing surveys and an in-person evaluation, and postpartum women.


Recruitment information / eligibility

Status Completed
Enrollment 1222
Est. completion date May 25, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Community dwelling - Age =18 years old - Female sex assigned at birth - Fluent in written and spoken English - Able to read and provide informed consent Exclusion Criteria: - Institutional living arrangement, e.g., skilled nursing, long term care or rehabilitation center - Physical or mental condition that would prohibit self-administration of questionnaire either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States University of Alabama at Birmingham Birmingham Alabama
United States Loyola University Chicago Chicago Illinois
United States University of Minnesota Minneapolis Minnesota
United States Yale University New Haven Connecticut
United States University of Pennsylvania Philadelphia Pennsylvania
United States Washington University School of Medicine Saint Louis Missouri
United States University of California, San Diego San Diego California

Sponsors (9)

Lead Sponsor Collaborator
University of Minnesota Loyola University Chicago, University of Alabama at Birmingham, University of California, San Diego, University of Illinois at Chicago, University of Michigan, University of Pennsylvania, Washington University School of Medicine, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (24)

American Educational Research Association. Standards for Educational and Psychological Testing. (Association AP, Education NC on M in, (U.S.) JC on S for E and PT, eds.). Washington, DC: Washington, DC : American Educational Research Association; 2014.

Bandilla W, Bosnjak M, Altdorfer P. Survey Administration Effects?: A Comparison of Web-Based and Traditional Written Self-Administered Surveys Using the ISSP Environment Module. Soc Sci Comput Rev. 2003;21(2):235-243. doi:10.1177/0894439303021002009.

Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. — View Citation

Brady SS, Bavendam TG, Berry A, Fok CS, Gahagan S, Goode PS, Hardacker CT, Hebert-Beirne J, Lewis CE, Lewis JB, Kane Low L, Lowder JL, Palmer MH, Wyman JF, Lukacz ES; Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium. The Prevention of Lower Urinary Tract Symptoms (PLUS) in girls and women: Developing a conceptual framework for a prevention research agenda. Neurourol Urodyn. 2018 Nov;37(8):2951-2964. doi: 10.1002/nau.23787. Epub 2018 Aug 22. — View Citation

CAMPBELL DT, FISKE DW. Convergent and discriminant validation by the multitrait-multimethod matrix. Psychol Bull. 1959 Mar;56(2):81-105. — View Citation

Chin HB, Baird DD, McConnaughey DR, Weinberg CR, Wilcox AJ, Jukic AM. Long-term Recall of Pregnancy-related Events. Epidemiology. 2017 Jul;28(4):575-579. doi: 10.1097/EDE.0000000000000660. — View Citation

Cronbach L. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16(3):297-334. doi:10.1007/BF02310555.

Dillman DA, Sangster RL, Tarnai J, Rockwood TH. Understanding differences in people's answers to telephone and mail surveys. New Dir Eval. 1996;1996(70):45-61. doi:10.1002/ev.1034.

Gorsuch RL. Common Factor Analysis versus Component Analysis: Some Well and Little Known Facts. Multivariate Behav Res. 1990 Jan 1;25(1):33-9. doi: 10.1207/s15327906mbr2501_3. — View Citation

Hawkins M, Elsworth GR, Osborne RH. Application of validity theory and methodology to patient-reported outcome measures (PROMs): building an argument for validity. Qual Life Res. 2018 Jul;27(7):1695-1710. doi: 10.1007/s11136-018-1815-6. Epub 2018 Feb 20. — View Citation

Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol. 1996 Jun;77(6):805-12. — View Citation

Kane MT. Validating the Interpretations and Uses of Test Scores. J Educ Meas. 2013;50(1):1-73. doi:10.1111/jedm.12000.

Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997 Dec;104(12):1374-9. — View Citation

Lukacz ES, Bavendam TG, Berry A, Fok CS, Gahagan S, Goode PS, Hardacker CT, Hebert-Beirne J, Lewis CE, Lewis J, Low LK, Lowder JL, Palmer MH, Smith AL, Brady SS. A Novel Research Definition of Bladder Health in Women and Girls: Implications for Research and Public Health Promotion. J Womens Health (Larchmt). 2018 Aug;27(8):974-981. doi: 10.1089/jwh.2017.6786. Epub 2018 May 24. — View Citation

Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. Births: Final Data for 2017. Natl Vital Stat Rep. 2018 Nov;67(8):1-50. — View Citation

McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993 Mar;31(3):247-63. — View Citation

Messick S. The interplay of evidence and consequences in the validation of performance assessments. ETS Res Rep Ser. 1992;1992(1):i-42. doi:10.1002/j.2333-8504.1992.tb01470.x.

Messick S. VALIDITY. Educ Test Serv Res Rep Ser. 1987;1987(2):i-208. doi:10.1002/j.2330-8516.1987.tb00244.x.

Miller JM, Ashton-Miller JA, Delancey JO. Quantification of cough-related urine loss using the paper towel test. Obstet Gynecol. 1998 May;91(5 Pt 1):705-9. — View Citation

Naughton MJ, Donovan J, Badia X, Corcos J, Gotoh M, Kelleher C, Lukacs B, Shaw C. Symptom severity and QOL scales for urinary incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S114-23. Review. — View Citation

Schwarz N, Strack F, Hippler H, Bishop G. The impact of administration mode on response effects in survey measurement. Jobe JB, Loftus EF, eds. Appl Cogn Psychol. 1991;5(3):193-212. doi:10.1002/acp.2350050304.

Streiner D. Health Measurement Scales : A Practical Guide to Their Development and Use. Fifth edit. (Norman GR, Cairney J, ebrary I, eds.). New York, New York: New York, New York : Oxford University Press; 2015.

Swartz RJ, de Moor C, Cook KF, Fouladi RT, Basen-Engquist K, Eng C, Carmack Taylor CL. Mode effects in the center for epidemiologic studies depression (CES-D) scale: personal digital assistant vs. paper and pencil administration. Qual Life Res. 2007 Jun;16(5):803-13. Epub 2007 Feb 13. — View Citation

Vernon SW, Tiro JA, Vojvodic RW, Coan S, Diamond PM, Greisinger A, Fernandez ME. Reliability and validity of a questionnaire to measure colorectal cancer screening behaviors: does mode of survey administration matter? Cancer Epidemiol Biomarkers Prev. 2008 Apr;17(4):758-67. doi: 10.1158/1055-9965.EPI-07-2855. Epub 2008 Apr 1. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Bladder Health Instrument Multi-item measurement is used to assess the range of bladder health dimensions as defined by the model of bladder health adopted by the PLUS consortium. It is anticipated that the self-administeredBHI instrument (PAPI or CASI) will consist of approximately 85 items: 53-67 are items all respondents will be asked to answer, and 48 are asked only of women who self-identify as experiencing a specific LUTS. The items cover the range of bladder health dimensions specified by our model. Will be assessed throughout the duration of study, an average of one year.
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