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

Institute of Health Information and Statistics of the Czech Republic

Status: Enrolling

Conditions: Overactive Bladder (OAB)

Treatments: Other: Standardized Screening Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07371000

UZIS 2024/3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,000 participants in 1 patient group

OAB Screening Arm

Other group

Description:

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.

Treatment:

Other: Standardized Screening Protocol