Health-related QoF Between OAB-wet and OAB-dry Women

Quality of Life Clinical Trial

Official title:

Comparisons of Health-Related Quality of Life Between Overactive Bladder-wet and -Dry Women Based on Bladder Diary

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806855
• Other study ID #: 201810092RINB
• Status: Completed
• Start date: July 1, 2009
• Est. completion date: January 31, 2018

Study information

• Verified date: November 2018
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Overactive bladder syndrome (OAB) has a great negative impact on health-related quality of life. In literatures, few studies reported the comparisons of health related quality of life between OAB-wet and OAB-dry female patients. Thus, our aim is to compare the clinical variables and health-related quality of life between OAB-wet and OAB-dry women.

Description:

Between July 2009 and January 2018, all women with OAB visiting a medical center for evaluation were reviewed. The classification of OAB-wet or OAB-dry is based on the record of the three-day bladder diary of each patient. The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet, otherwise, OAB-dry. Besides, only female OAB patients with available King's Health Questionnaire (KHQ) data were reviewed in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1071
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. More than 20-year-old

2. Female

3. Diagnosed with overactive bladder by bladder diary

Exclusion Criteria:

1. Younger than 20-year-old

2. Pregnant or planned to be pregnant

Related Conditions & MeSH terms

• Quality of Life

Intervention

Diagnostic Test:
• Bladder diary
3-day bladder diary

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

References & Publications (7)

Coyne KS, Sexton CC, Bell JA, Thompson CL, Dmochowski R, Bavendam T, Chen CI, Quentin Clemens J. The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: results from OAB-POLL. Neurourol Urodyn. 2013 Mar;32(3):230-7. doi: 10.1002/nau.22295. Epub 2012 Jul 27. — View Citation

Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic burden of urgency urinary incontinence in the United States: a systematic review. J Manag Care Pharm. 2014 Feb;20(2):130-40. Review. — View Citation

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798. Review. — View Citation

Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27. Review. — View Citation

Onukwugha E, Zuckerman IH, McNally D, Coyne KS, Vats V, Mullins CD. The total economic burden of overactive bladder in the United States: a disease-specific approach. Am J Manag Care. 2009 Mar;15(4 Suppl):S90-7. — View Citation

Powell LC, Szabo SM, Walker D, Gooch K. The economic burden of overactive bladder in the United States: A systematic literature review. Neurourol Urodyn. 2018 Apr;37(4):1241-1249. doi: 10.1002/nau.23477. Epub 2018 Jan 13. Review. — View Citation

Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. Epub 2002 Nov 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Quality of life	Use questionnaire to evaluate the difference in QoF of OAB-wet and OAB-dry women	Between July 2009 and January 2018