Early Detection of OAB and Elimination of Negative Impact on Quality of Life

January 22, 2026 updated by: Institute of Health Information and Statistics of the Czech Republic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia
        • Not yet recruiting
        • Brno University Hospital
        • Contact:
      • Brno, Czechia
        • Not yet recruiting
        • GYN-LINE, s.r.o.
        • Contact:
          • Martin Huser, M.D.
      • Hořovice, Czechia
        • Not yet recruiting
        • Hospital Hořovice
        • Contact:
          • Tomáš Hyndrák, M.D.
      • Hradec Králové, Czechia
        • Not yet recruiting
        • University Hospital Hradec Kralove
        • Contact:
          • Ondřej Novák, M.D.
      • Jablonec nad Nisou, Czechia
        • Not yet recruiting
        • Hospital Jablonec nad Nisou
        • Contact:
          • Vít Mairich, M.D.
      • Karlovy Vary, Czechia
        • Not yet recruiting
        • AGYNO s.r.o.
        • Contact:
          • Martin Smažinka, M.D.
      • Kolín, Czechia
        • Not yet recruiting
        • Oblastni nemocnice Kolin a.s.
        • Contact:
          • Jitka Konvalinová, M.D.
      • Olomouc, Czechia
        • Not yet recruiting
        • Olomouc University Hospital
        • Contact:
      • Ostrava, Czechia
        • Not yet recruiting
        • University Hospital Ostrava
        • Contact:
          • Jan Krhut, M.D.
      • Ostrava, Czechia
        • Not yet recruiting
        • GYNOVA s.r.o.
        • Contact:
          • Olga Szabová, M.D.
      • Ostrava, Czechia
        • Not yet recruiting
        • Hospital AGEL Ostrava - Vítkovice a.s.
        • Contact:
          • Petr Vašek, M.D.
      • Pilsen, Czechia
        • Not yet recruiting
        • Gyncare Michael Švec s.r.o.
        • Contact:
          • Zdeněk Rušavý, M.D.
      • Pilsen, Czechia
        • Not yet recruiting
        • Mulačova nemocnice
        • Contact:
          • Pavel Chaloupka, M.D.
      • Prague, Czechia
        • Recruiting
        • General University Hospital
        • Contact:
      • Prague, Czechia
        • Not yet recruiting
        • University Hospital Bulovka
        • Contact:
          • Petr Hubka, M.D.
      • Prague, Czechia
        • Not yet recruiting
        • GynUp! s.r.o.
        • Contact:
          • Jiří Chaloupecký, M.D.
      • Prague, Czechia
        • Not yet recruiting
        • University Thomayer Hospital
        • Contact:
          • Petr Kolek
      • Prague, Czechia
        • Not yet recruiting
        • Uroklinikum s.r.o.
        • Contact:
          • Tomáš Fučík, M.D.
      • Sokolov, Czechia
        • Not yet recruiting
        • Sokolov Hospital
        • Contact:
          • Vladimír Velický, M.D.
      • České Budějovice, Czechia
        • Not yet recruiting
        • České Budějovice Hospital
        • Contact:
          • Erika Francová, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: OAB Screening Arm
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.
Other: Standardized Screening Protocol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of examination in 3 months
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
from enrollment up to 1 week
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
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
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
Through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Collaborators

General University Hospital, Prague

Investigators

  • Study Director: Jaromír Mašata, Professor, General University Hospital of Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZIS 2024/3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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