NCT03228485

Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

The Feasibility and Acceptability of a (Mobile) Application for Men With LUTS/BPH: a Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Société Internationale d'Urologie · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostatic Hyperplasia
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DEVICE	MyBPH Care mobile app	The application that will give daily medication reminders and via which the questionnaires can be filled out.

Timeline

• Start date: 2019-04-04
• Primary completion: 2023-01-31
• Completion: 2023-03-01
• First posted: 2017-07-25
• Last updated: 2025-05-18

Locations

5 sites across 5 countries: Greece, Italy, Portugal, Spain, Turkey (Türkiye)