Overactive Bladder (OAB)NCT07371000
Early Detection of OAB and Elimination of Negative Impact on Quality of Life
A study testing Standardized Screening Protocol in people with Overactive Bladder (OAB), run by Institute of Health Information and Statistics of the Czech Republic at 20 sites in Czechia.
Trial summary
Overactive bladder (OAB) is one of the most common health problems in the adult population. The goal of this project is to improve the awareness of the problem and to correctly refer the targeted persons to a specialist or a doctor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Standardized Screening Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 20 sitesCzechia
- Study dates
- 1 Sep 2025to 31 Aug 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Consent to Participate in the Project and Consent to the Processing of Personal Data (online and paper format)
- Men and women over 18 years of age with increased urinary frequency (more than 7 times in 24 hours)
- Optional inclusion criteria:
- Nycturia and/or urge incontinence.
Who cannot join
- Unsigned Consent to Participate in the Project and Consent to the Processing of Personal Data.
- Current treatment of OAB, acute problems, suspicion of another disease causing OAB symptoms (haematuria, suspected bladder cancer, etc.)
- Inflammation of the lower urinary tract.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Czechia20 sites
Brno University Hospital
Brno
GYN-LINE, s.r.o.
Brno
České Budějovice Hospital
České Budějovice
Hospital Hořovice
Hořovice
University Hospital Hradec Králové
Hradec Králové
Hospital Jablonec nad Nisou
Jablonec nad Nisou
AGYNO s.r.o.
Karlovy Vary
Oblastní nemocnice Kolín a.s.
Kolín
Olomouc University Hospital
Olomouc
GYNOVA s.r.o.
Ostrava
Hospital AGEL Ostrava - Vítkovice a.s.
Ostrava
University Hospital Ostrava
Ostrava
Gyncare Michael Švec s.r.o.
Pilsen
Mulačova nemocnice
Pilsen
General University Hospital
Prague
GynUp! s.r.o.
Prague
University Hospital Bulovka
Prague
University Thomayer Hospital
Prague
Uroklinikum s.r.o.
Prague
Sokolov Hospital
Sokolov
About this study
Official title: Early Detection of Overactive Bladder and Elimination of Negative Impact on Quality of Life
Overactive bladder (OAB) is one of the most common health problems in the adult population. The goal of this project is to improve the awareness of the problem and to correctly refer the targeted persons to a specialist or a doctor. This will be provided by an online screening tool, designed as web platform and mobile application, where the data will be stored in respect to GDPR. People with a positive result from the online screening tool will be offered an examination by a specialist (gynaecologist, urogynaecologist, urologist) involved in the project. The specialist will have access to the results from the online screening tool - he/she will log into the web platform with a view of the participants profile. He/she will perform the diagnosis, confirm or refute the diagnosis and complement it with any further diagnostic tests and set the standard treatment.
Read the detailed description
Overactive bladder (OAB) is one of the most common health problems in the adult population (15-20% prevalence), with just under half of those affected seeking professional medical help. The goal of this project is to improve the awareness of the problem and to correctly refer the targeted participants to a specialist or a doctor who is knowledgeable about the problem and who will set up an adequate therapy.
A targeted PR campaign will direct those interested in joining the pilot screening project to a website with information about OAB and information about the pilot screening process. The web platform will also guide the user to create a secure user profile to participate in the project, where they will complete validated questionnaires related to OAB, necessary personal and family history data to optimize follow-up diagnosis during the in-person examination with a specialist, and a validated questionnaire measuring quality of life. After completing the online screening tool, the user will be offered a referral to a specialist in the vicinity. Participation in the online screening tool will be conditional on checking the online Consent to Participate box and Consent to Disclose Personal Data in accordance with GDPR.
People with a positive result from the online screening tool will be offered an examination by a specialist (gynaecologist, urogynaecologist, urologist) involved in the project. The specialist will have access to the results from the online screening tool - he/she will log into the web platform with a view of the participant's profile. He/she will perform the diagnosis, confirm or refute the diagnosis and complement it with any further diagnostic tests and set the standard treatment.
The data collected will be used to properly evaluate the pilot project in line with its objectives. An analysis of the problems and risks of the project with regard to the whole pilot screening process and a simplified cost evaluation will also be carried out.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Standardized Screening Protocol
- Keywords
- Overactive bladder, Screening, Telemedicine, Online screening tool
- 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.
Standardized Screening ProtocolOther
After completing the online screening tool (including validated questionnaires), selected participants are offered an appointment with a specialist who will perform a diagnosis, confirm or rule out OAB and set up adequate therapy according to recommended procedures.
| Study group | Role | What they receive |
|---|---|---|
| OAB Screening Arm | Other | Participants matching all the inclusion \& exclusion criteria will undergo a standardized screening process for the diagnosis of OAB. This process involves the use of an online screening self-testing tool, where the data from individual questionnaires specific to OAB diagnosis will be evaluated by a specialist. Receives: Other: Standardized Screening Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot testing with 1,000 participants
Pilot testing of the procedure on a sample of 1,000 people who will undergo an online self-diagnostic screening tool and be examined by a urogynecologist/urologist.
Measured: From enrollment to the end of examination in 3 months
Number of participants (completion of anonymous screening test)
Number of participants who complete anonymous screening test based on three questions reffering to urology health
Measured: from enrollment up to 1 week
Percentage of people with suspected OAB who agreed to participate in a follow-up examination with specialist
Measured: From enrollment up to 3 months
Percentage of people with a specialist confirmed diagnosis of OAB at the face-to-face visit
Measured: Through study completion, an average of 6 months
Percentage of people who attended follow-up examination after 3 months
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- General University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Jaromír Mašata, Professor, Study director, General University Hospital of Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371000
- Sponsor's protocol ID
- UZIS 2024/3
- Status last verified
- Nov 2026
- First submitted
- 14 Jan 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Overactive Bladder and Elimination of Negative Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT07371000
- Acronym / sponsor ID
- UZIS 2024/3
- Conditions
- Overactive Bladder (OAB)
- Keywords
- Overactive bladder, Screening, Telemedicine, Online screening tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- General University Hospital, Prague
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 27 Jan 2026 (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) is one of the most common health problems in the adult population. The goal of this project is to improve the awareness of the problem and to correctly refer the targeted persons to a specialist or a doctor. This will be provided by an online screening tool, designed as web platform and mobile application, where the data will be stored in respect to GDPR. People with a positive result from the online screening tool will be offered an examination by a specialist (gynaecologist, urogynaecologist, urologist) involved in the project. The specialist will have access to the results from the online screening tool - he/she will log into the web platform with a view of the participants profile. He/she will perform the diagnosis, confirm or refute the diagnosis and complement it with any further diagnostic tests and set the standard treatment.
Detailed description
Overactive bladder (OAB) is one of the most common health problems in the adult population (15-20% prevalence), with just under half of those affected seeking professional medical help. The goal of this project is to improve the awareness of the problem and to correctly refer the targeted participants to a specialist or a doctor who is knowledgeable about the problem and who will set up an adequate therapy.
A targeted PR campaign will direct those interested in joining the pilot screening project to a website with information about OAB and information about the pilot screening process. The web platform will also guide the user to create a secure user profile to participate in the project, where they will complete validated questionnaires related to OAB, necessary personal and family history data to optimize follow-up diagnosis during the in-person examination with a specialist, and a validated questionnaire measuring quality of life. After completing the online screening tool, the user will be offered a referral to a specialist in the vicinity. Participation in the online screening tool will be conditional on checking the online Consent to Participate box and Consent to Disclose Personal Data in accordance with GDPR.
People with a positive result from the online screening tool will be offered an examination by a specialist (gynaecologist, urogynaecologist, urologist) involved in the project. The specialist will have access to the results from the online screening tool - he/she will log into the web platform with a view of the participant's profile. He/she will perform the diagnosis, confirm or refute the diagnosis and complement it with any further diagnostic tests and set the standard treatment.
The data collected will be used to properly evaluate the pilot project in line with its objectives. An analysis of the problems and risks of the project with regard to the whole pilot screening process and a simplified cost evaluation will also be carried out.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OAB Screening Arm | Other | Other: Standardized Screening ProtocolParticipants matching all the inclusion \& exclusion criteria will undergo a standardized screening process for the diagnosis of OAB. This process involves the use of an online screening self-testing tool, where the data from individual questionnaires specific to OAB diagnosis will be evaluated by a specialist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed Consent to Participate in the Project and Consent to the Processing of Personal Data (online and paper format)
- Men and women over 18 years of age with increased urinary frequency (more than 7 times in 24 hours)
- Nycturia and/or urge incontinence.
Key exclusion criteria (3 listed)
- Unsigned Consent to Participate in the Project and Consent to the Processing of Personal Data.
- Current treatment of OAB, acute problems, suspicion of another disease causing OAB symptoms (haematuria, suspected bladder cancer, etc.)
- Inflammation of the lower urinary tract.
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 |
|---|---|---|
| Standardized Screening ProtocolAfter completing the online screening tool (including validated questionnaires), selected participants are offered an appointment with a specialist who will perform a diagnosis, confirm or rule out OAB and set up adequate therapy according to recommended procedures. | Other | OAB Screening Arm |
Primary outcome
Pilot testing with 1,000 participants
Time frame: From enrollment to the end of examination in 3 months
Pilot testing of the procedure on a sample of 1,000 people who will undergo an online self-diagnostic screening tool and be examined by a urogynecologist/urologist.
Number of participants (completion of anonymous screening test)
Time frame: from enrollment up to 1 week
Number of participants who complete anonymous screening test based on three questions reffering to urology health
Percentage of people with suspected OAB who agreed to participate in a follow-up examination with specialist
Time frame: From enrollment up to 3 months
Percentage of people with a specialist confirmed diagnosis of OAB at the face-to-face visit
Time frame: Through study completion, an average of 6 months
Percentage of people who attended follow-up examination after 3 months
Time frame: Through study completion, an average of 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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.
Jaromír Mašata, Professor study director
General University Hospital of Prague
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Screening Protocol in people with Overactive Bladder (OAB), run by Institute of Health Information and Statistics of the Czech Republic at 20 sites in Czechia.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pilot testing with 1,000 participants (time frame: From enrollment to the end of examination in 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.