Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

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

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Prostatic Hyperplasia
• Intervention / Treatment: Device: MyBPH Care mobile app

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Greece
  • Larissa, Greece, 10
    • University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases
• Italy
  • Florence, Italy
    • University of Florence
• Portugal
  • Porto, Portugal
    • Hospital de Santo Antonio
• Spain
  • Madrid, Spain, 28023
    • Hospital Universitario La Zarzuela
• Turkey
  • Istanbul, Turkey
    • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Male
• Age ≥ 40
• Bothersome LUTS
• Start of medical therapy for LUTS

• Either:

  1. No previous LUTS/BPH treatment (medical or invasive), or
  2. Under medical treatment
• 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:

• Previous LUTS/BPH treatment with 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MyBPH Care; All patients enrolled in this study.	Device: MyBPH Care mobile app; The application that will give daily medication reminders and via which the questionnaires can be filled out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Société Internationale d'Urologie
• Investigators: Study Chair: Stavros Gravas, MD, Societe Internationale d'Urologie

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Smartphone; mhealth; Application; Pilot
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: uCARE-2018-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No