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

Официальное название

Early Detection of Overactive Bladder and Elimination of Negative Impact on Quality of Life

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Pilot testing with 1,000 participants [Срок оценки: From enrollment to the end of examination in 3 months]
• Number of participants (completion of anonymous screening test) [Срок оценки: from enrollment up to 1 week]
• Percentage of people with suspected OAB who agreed to participate in a follow-up examination with specialist [Срок оценки: From enrollment up to 3 months]
• Percentage of people with a specialist confirmed diagnosis of OAB at the face-to-face visit [Срок оценки: Through study completion, an average of 6 months]
• Percentage of people who attended follow-up examination after 3 months [Срок оценки: Through study completion, an average of 9 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Чехия · 20 центров

• 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
• … и ещё 12 центров

Идентификаторы

NCT: NCT07371000 · UZIS 2024/3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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