Impact of OAB Symptoms on Quality of Life in Croatia

Overactive Bladder Clinical Trial

— OAB-CRO  

Official title:

Impact of OAB Symptoms on Work, Quality of Life and Treatment-seeking Behavior in Croatia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04865328
• Other study ID #: PetrovaGyn
• Status: Not yet recruiting
• Start date: May 10, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: April 2021
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Overactive bladder (OAB) has a negative impact on the daily activities of affected individuals. OAB affects an estimated 12-17% of adults and has a similar reported prevalence in men and women. It has the potential to impair multiple domains of quality of life, including restriction of social and work life, while also resulting in higher healthcare resource use and costs.

The primary objective of the present study was to evaluate, in a Croatian population reporting symptoms of OAB, the effect on work productivity and treatment behaviors (treatment seeking, receiving treatment, treatment dissatisfaction and treatment discontinuation).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: May 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• consenting adult patients who had an OAB diagnosis by their healthcare practitioner and were about to start mirabegron treatment as part of routine clinical practice were eligible for enrollment.

Exclusion Criteria:

• mixed incontinence where stress incontinence was the predominant symptom (as determined by the investigator)

• severe uncontrolled hypertension (i.e. systolic blood pressure =180 mm Hg and/or diastolic blood pressure =110 mm Hg)

• anxiety and/or depression

• pregnancy

• women who reported having either a current or previous (within one month) urinary tract infection

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• Overactive Bladder-Validated 8-question Screener (OAB-V8)
OAB-V8 is an eight-item, self-reported questionnaire that assesses the burden of OAB and the degree of bother caused by the symptoms. Since its development as a subscale of the overactive bladder questionnaire (OAB-q), the OAB-V8 questionnaire has been used to screen for OAB and to assess OAB symptom burden and severity.

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre Zagreb, Croatia	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OAB-V8 score > 8	The primary study objective is to investigate the impact of individual LUTS on specific outcomes in the population reporting OAB symptoms. OAB-V8 score.	At the point of recruitment