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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04865328
Other study ID # PetrovaGyn
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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