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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03806855
• Collaborator: (none)
• Enrollment: 1,071
• Actual Duration (Months): 103

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life	Diagnostic Test: Bladder diary

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1071 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Comparisons of Health-Related Quality of Life Between Overactive Bladder-wet and -Dry Women Based on Bladder Diary
• Actual Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jan 31, 2018
• Actual Study Completion Date: Jan 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
OAB-wet 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.	Diagnostic Test: Bladder diary; 3-day bladder diary
OAB-dry 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 absence of urgency associated incontinence was defined to be OAB-dry.	Diagnostic Test: Bladder diary; 3-day bladder diary

Outcome Measures

Primary Outcome Measures

1. Difference in Quality of life [Between July 2009 and January 2018]

   Use questionnaire to evaluate the difference in QoF of OAB-wet and OAB-dry women

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Ho-Hsiung Lin, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT03806855
• Other Study ID Numbers: 201810092RINB
• First Posted: Jan 16, 2019
• Last Update Posted: Jan 16, 2019
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital: Health Related Quality of Life; Overactive Bladder; Bladder Diary

Study Results

No Results Posted as of Jan 16, 2019