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This study assesses the feasibility, and acceptability of a (mobile) application for men presenting at their physician's office with LUTS/BPH; starting with medical therapy and naïve for treatment. Patients will be enrolled in the study by their physician (GP or urologist). The patients will receive a daily medication reminder including frequent feedback on medication adherence. Furthermore, standard questionnaires will be filled out via the application. The hypothesis of this pilot study is that application is feasible and accepted in this group of patients.
Rationale:
One of the next developments in healthcare is digitalization, including (mobile) applications that could support healthcare providers. A significant number of aging men suffer from lower urinary tract symptoms (LUTS), often caused by benign prostate hyperplasia (BPH). LUTS/BPH is primarily treated by physicians (GPs or Urologists). Optimal evaluation of patients with LUTS/BPH, treatment selection and follow-up by the physicians and medication adherence are essential in the management of LUTS. This pilot project represents a strong collaboration between a urological association, urologists, and physicians in supporting healthcare improvement for LUTS/BPH with the use of a (mobile) application. The hypothesis is that the (mobile) application can support the patient in medication adherence and improve the adherence by feedback and that the application can help to collect objective disease information with electronic questionnaires.
Objectives:
The primary objective is to assess the feasibility, and acceptability of a (mobile) application for men presenting at their general practitioner/or urologist with LUTS/BPH who are either: under treatment, or who may require medical therapy for the first time.
The secondary objectives are to identify potential gaps, clarify controversial points of the application, to document the communication between patients, physicians and supervising urologists in order to optimize (if necessary) the application, to assess medication adherence and to record if treatment provided by physicians is in compliance with the guidelines recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyBPH Care | All patients enrolled in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyBPH Care mobile app | Device | The application that will give daily medication reminders and via which the questionnaires can be filled out. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a mobile application for LUTS | The feasibility is assessed by the application use for men presenting at their general practitioner/or urologist with LUTS/BPH who are either: under treatment, or who may require medical therapy for the first time. The patient application will be judged as Definitely Feasible if the study is completed for ≥70% eligible patients, Possibly Feasible (completed for 50-69% eligible patients) or Not Feasible (completed for <50%). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and satisfaction of a mobile application for LUTS | In order to assess the acceptance and satisfaction of the mobile application including the application subjective quality and perceived impact, a questionnaire will be used. This questionnaire is based on a standardized application rating questionnaire, namely the user Mobile Application Rating Scale (uMARS). Outcomes are described and compared between centers. |
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Inclusion Criteria:
Male
Age ≥ 40
Bothersome LUTS
Start of medical therapy for LUTS
Either:
In possession of a smartphone, tablet or computer with internet connection
Access to email
Fluent speaking and reading of the national language
Signed informed consent
Exclusion Criteria:
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The population will be men, age ≥ 40, presenting at their physician's office with LUTS/BPH symptoms and are either: a) treatment naïve for LUTS/BPH or b) under medical treatment.
The study will be conducted by five centers in five countries: Institute for Monitoring of Urogenital Diseases in Larissa, Greece, the Istanbul Medipol University in Turkey, the Hospital Universitario la Zarzuela in Spain, the Hospital de San António in Portugal, and the University of Florence in Italy. The participating physicians will be from these areas and thus so will the participants.
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| Name | Affiliation | Role |
|---|---|---|
| Stavros Gravas, MD | Societe Internationale d'Urologie | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases | Larissa | 10 | Greece | |||
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 6 months |
| Medication adherence | Self-reported medication adherence by the patient via the application over the full period of the pilot. | 6 months |
| Compliance to guidelines | Descriptive comparison between the medication prescribed by the physician and the advised medication according to the international guidelines based on the patient characteristics. | At baseline |
| Referral network | Evaluation of the referral communication between the physicians and the supervising urologist by questions in the final questionnaire. | At the end of the 6 months period |
| University of Florence |
| Florence |
| Italy |
| Hospital de Santo Antonio | Porto | Portugal |
| Hospital Universitario la Zarzuela | Madrid | 28023 | Spain |
| Istanbul Medipol University | Istanbul | Turkey (Türkiye) |
| D052801 |
| Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |