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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Screening Protocol | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Optional inclusion criteria:
- Nycturia and/or urge incontinence.
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kateřina Ondrášková, Msc | Contact | 604603143 | katerina.ondraskova@uzis.cz | |
| Lucie Mandelová, PhD | Contact | lucie.mandelova@uzis.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jaromír Mašata, Professor | General University Hospital of Prague | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno University Hospital | Not yet recruiting | Brno | Czechia |
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| GYN-LINE, s.r.o. | Not yet recruiting | Brno | Czechia |
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| České Budějovice Hospital | Not yet recruiting | České Budějovice | Czechia |
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| Hospital Hořovice | Not yet recruiting | Hořovice | Czechia |
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| University Hospital Hradec Králové | Not yet recruiting | Hradec Králové | Czechia |
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| Hospital Jablonec nad Nisou | Not yet recruiting | Jablonec nad Nisou | Czechia |
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| AGYNO s.r.o. | Not yet recruiting | Karlovy Vary | Czechia |
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| Oblastní nemocnice Kolín a.s. | Not yet recruiting | Kolín | Czechia |
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| Olomouc University Hospital | Not yet recruiting | Olomouc | Czechia |
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| GYNOVA s.r.o. | Not yet recruiting | Ostrava | Czechia |
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| Hospital AGEL Ostrava - Vítkovice a.s. | Not yet recruiting | Ostrava | Czechia |
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| University Hospital Ostrava | Not yet recruiting | Ostrava | Czechia |
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| Gyncare Michael Švec s.r.o. | Not yet recruiting | Pilsen | Czechia |
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| Mulačova nemocnice | Not yet recruiting | Pilsen | Czechia |
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| General University Hospital | Recruiting | Prague | Czechia |
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| GynUp! s.r.o. | Not yet recruiting | Prague | Czechia |
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| University Hospital Bulovka | Not yet recruiting | Prague | Czechia |
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| University Thomayer Hospital | Not yet recruiting | Prague | Czechia |
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| Uroklinikum s.r.o. | Not yet recruiting | Prague | Czechia |
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| Sokolov Hospital | Not yet recruiting | Sokolov | Czechia |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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