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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Health Information and Statistics of the Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Standardized Screening Protocol

    Other intervention

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: OAB Screening ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of examination in 3 months
2

Number of participants (completion of anonymous screening test)

Number of participants who complete anonymous screening test based on three questions reffering to urology health

Time frame
from enrollment up to 1 week
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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