| Primary sponsors | Société Internationale d'Urologie |
|---|---|
| Secondary sponsors (if any) | |
| Overall study status | Ongoing |
| Recruitment status | Recruiting |
Descriptive Information | |
| Study 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 (General Practitioners 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 general practitioners in supporting healthcare improvement for LUTS/BPH with use of an (mobile) application. Note: In the time of COVID-19, patients who are already under treatment are given the opportunity to participate in the study. The patient can be informed about the study during their phone consultation. |
| Study objectives | Primary objective: 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.
Secondary objectives: 1. To capture medical adherence using electronic reminders. 2. To record if treatment provided by physicians is in compliance with the guidelines recommendations. 3. To evaluate the communication between physicians and supervising urologists |
| Medical condition | Benign prostatic hyperplasia |
| Study population | The population will be men, age ≥ 40 yrs, presenting at their physician’s office with LUTS/BPH symptoms and are either: a) treatment naïve for LUTS/BPH or b) under medical treatment. |
| Treatment type | Observational |
| Primary outcome measures | 1.Feasibility of a mobile application for LUTS. The feasibility is assessed by the application use of patients. 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%). [Time Frame: 6 months] |
| Secondary outcome measures | 1. 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. [Time Frame: 6 months] 2. Medication adherence. Self-reported medication adherence by the patient via the application over the full period of the pilot. [Time Frame: 6 months] 3. Compliance to guidelines 4. Referral network |
Recruitment Information | |
| Date of first enrollment | 2019-04-04 |
| Study start date | 2019-04-01 |
| Estimated study completion date | 2021-04-10 |
| Estimated primary completion date | 2021-04-01 |
| Eligibility | Please see inclusion and exclusion criteria below. |
| Inclusion criteria | In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Male - Age ≥ 40 - Bothersome LUTS - No previous LUTS/BPH invasive treatment (medical or invasive) - 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
Note: COVID-19 related considerations If new or ongoing participants show symptoms consistent with COVID-19 or have tested positive using a test consistent with the institutional standard of care, the study participation should be evaluated as per local health authority instructions to ensure safety of the patient. |
| Exclusion criteria | A potential subject who meets any of the following criteria will be excluded from participation in this study: - Previous LUTS/BPH treatment with medication or surgery - Previous pelvic surgery or radiotherapy - History of neurological disease - History of bladder or prostate cancer - Unable to provide informed consent - Analphabet - Unable to operate a smartphone/ tablet/computer - Incapable of understanding the language in which the information for the patient is given
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| Primary Facility Contact | |
| Title | Ms. |
| First name | Christine |
| Last name | Albino |
| Telephone | +1-514-465-0367 |
| [email protected] | |
| Overall Study Officials | |
| First name | Stavros |
| Last name | Gravas |
| Degree | MD, PhD, FEBU |
| Organizational affiliation | University Hospital of Larissa and Institute for Monitoring of Urogenital Diseases |
| Official's role | Study Director |
Centers/Contacts | |
| Greece - Leader | |
| Name | Stavros Gravas, MD, PhD, FEBU |
| Spain - Leader | |
| Name | Ignacio Moncada, MD |
| Portugal - Leader | |
| Name | Vitor Cavadas, MD |
| Italy - Leader | |
| Name | Mauro Gacci, MD |
| Turkey - Leader | |
| Name | Jean de la Rosette, MD, PhD |
| Turkey | |
| Name | Selcuk Guven, MD, PhD |
Publications/Documents | |
| Publication status | Pending |
| If other, please specify | |
| Publication link | |
