Impact of OAB Symptoms on Quality of Life in Croatia

• Conditions: Overactive Bladder
• Interventions: Other: Overactive Bladder-Validated 8-question Screener (OAB-V8)

• Registration Number: NCT04865328
• Lead Sponsor: University of Zagreb

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-04-25
• Last Update Submitted: 2021-04-25
• Study First Posted: 2021-04-29
• Last Update Posted: 2021-04-29
• Study Start: 2021-05-10
• Primary Completion: 2021-12-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OAB group	Overactive Bladder-Validated 8-question Screener (OAB-V8)	Group with diagnosed overactive bladder.

Primary Outcome Measures

Name	Time	Method
OAB-V8 score > 8	At the point of recruitment	The primary study objective is to investigate the impact of individual LUTS on specific outcomes in the population reporting OAB symptoms. OAB-V8 score.

Trial Locations

Locations (1)

Clinical Hospital Centre Zagreb, Croatia; 🇭🇷 Zagreb, Croatia