NCT07371000

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Sep 2025Aug 2026

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

January 14, 2026

Last Update Submit

January 22, 2026

Conditions

Keywords

Overactive bladderScreeningTelemedicineOnline screening tool

Outcome Measures

Primary Outcomes (5)

  • 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.

    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

    from enrollment up to 1 week

  • Percentage of people with suspected OAB who agreed to participate in a follow-up examination with specialist

    From enrollment up to 3 months

  • Percentage of people with a specialist confirmed diagnosis of OAB at the face-to-face visit

    Through study completion, an average of 6 months

  • Percentage of people who attended follow-up examination after 3 months

    Through study completion, an average of 9 months

Study Arms (1)

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.

Other: Standardized Screening Protocol

Interventions

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.

OAB Screening Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Brno University Hospital

Brno, Czechia

NOT YET RECRUITING

GYN-LINE, s.r.o.

Brno, Czechia

NOT YET RECRUITING

České Budějovice Hospital

České Budějovice, Czechia

NOT YET RECRUITING

Hospital Hořovice

Hořovice, Czechia

NOT YET RECRUITING

University Hospital Hradec Králové

Hradec Králové, Czechia

NOT YET RECRUITING

Hospital Jablonec nad Nisou

Jablonec nad Nisou, Czechia

NOT YET RECRUITING

AGYNO s.r.o.

Karlovy Vary, Czechia

NOT YET RECRUITING

Oblastní nemocnice Kolín a.s.

Kolín, Czechia

NOT YET RECRUITING

Olomouc University Hospital

Olomouc, Czechia

NOT YET RECRUITING

GYNOVA s.r.o.

Ostrava, Czechia

NOT YET RECRUITING

Hospital AGEL Ostrava - Vítkovice a.s.

Ostrava, Czechia

NOT YET RECRUITING

University Hospital Ostrava

Ostrava, Czechia

NOT YET RECRUITING

Gyncare Michael Švec s.r.o.

Pilsen, Czechia

NOT YET RECRUITING

Mulačova nemocnice

Pilsen, Czechia

NOT YET RECRUITING

General University Hospital

Prague, Czechia

RECRUITING

GynUp! s.r.o.

Prague, Czechia

NOT YET RECRUITING

University Hospital Bulovka

Prague, Czechia

NOT YET RECRUITING

University Thomayer Hospital

Prague, Czechia

NOT YET RECRUITING

Uroklinikum s.r.o.

Prague, Czechia

NOT YET RECRUITING

Sokolov Hospital

Sokolov, Czechia

NOT YET RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jaromír Mašata, Professor

    General University Hospital of Prague

    STUDY DIRECTOR

Central Study Contacts

Kateřina Ondrášková, Msc

CONTACT

Lucie Mandelová, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 27, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations