Impact of OAB Symptoms on Quality of Life in Croatia

NCT ID: NCT04865328

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2022-05-01

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).

Conditions

Overactive Bladder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

OAB group

Group with diagnosed overactive bladder.

Overactive Bladder-Validated 8-question Screener (OAB-V8)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Mislav Mikuš

MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Hospital Centre Zagreb, Croatia

Zagreb, , Croatia

Countries

Croatia

References

Mikus M, Ostroski M, Beljan P, Karadza M, Dumancic S, Sprem Goldstajn M, Coric M, Kalafatic D, Oreskovic S. Validation of the Croatian Version of the 8-Item Overactive Bladder Questionnaire (OAB-V8). Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):e687-e690. doi: 10.1097/SPV.0000000000001098.

Reference Type: DERIVED

PMID: 34534199 (View on PubMed)

Other Identifiers

PetrovaGyn

Identifier Type: -

Identifier Source: org_study_id