Impact of OAB Symptoms on Quality of Life in Croatia

NCT04865328 | Unknown

• 1 other identifier: PetrovaGyn
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

OAB group

Group with diagnosed overactive bladder.

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

Interventions

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

OAB group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with diagnosed overactive bladder without treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

Clinical Hospital Centre Zagreb, Croatia

Zagreb, 10 000, Croatia

Location

Related Publications (1)

• 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.

  PMID: 34534199 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 29, 2021
• Study Start: May 10, 2021
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)