Overactive BladderOAB-CRONCT04865328
Impact of OAB Symptoms on Quality of Life in Croatia
An observational study of Overactive Bladder, run by University of Zagreb at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Overactive Bladder-Validated 8-question Screener (OAB-V8)
- How many people
- 250 participants
- Where
- 1 siteCroatia
- Study dates
- 10 May 2021to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with diagnosed overactive bladder without treatment.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of OAB Symptoms on Work, Quality of Life and Treatment-seeking Behavior in Croatia
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
- Being tested
- Overactive Bladder-Validated 8-question Screener (OAB-V8)
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| OAB group | Group with diagnosed overactive bladder. Receives: Other: Overactive Bladder-Validated 8-question Screener (OAB-V8) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the point of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start10 May 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mislav Mikuš, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865328
- Sponsor's protocol ID
- PetrovaGyn
- Acronym
- OAB-CRO
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no intention to share IPD.
Publications
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.
PubMed 34534199
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of OAB Symptoms on Work, Quality of Life and Treatment-seeking Behavior in Croatia
- ClinicalTrials.gov ID
- NCT04865328
- Acronym / sponsor ID
- OAB-CRO / PetrovaGyn
- Conditions
- Overactive Bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 10 May 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OAB group | – | Other: Overactive Bladder-Validated 8-question Screener (OAB-V8)Group with diagnosed overactive bladder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with diagnosed overactive bladder without treatment.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | OAB group |
Primary outcome
OAB-V8 score > 8
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 34534199Mikus 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.
- Individual participant dataSharing planned: No. We have no intention to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OAB-V8 score > 8 (time frame: At the point of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04865328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.