Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

NCT03228485 | Completed

• 1 other identifier: uCARE-2018-002
• Study Type: observational
• Target: 200
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

Smartphone; Application; Pilot; mhealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acceptability and satisfaction of a mobile application for LUTS

  6 months

• Medication adherence

  6 months

• Compliance to guidelines

  At baseline

• Referral network

  At the end of the 6 months period

Study Arms (1)

MyBPH Care

All patients enrolled in this study.

Device: MyBPH Care mobile app

Interventions

MyBPH Care mobile app DEVICE

The application that will give daily medication reminders and via which the questionnaires can be filled out.

MyBPH Care

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male
• Age ≥ 40
• Bothersome LUTS
• Start of medical therapy for LUTS
• Either:
• No previous LUTS/BPH treatment (medical or invasive), or
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Internationale d'Urologie: lead

Study Sites (5)

University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases

Larissa, 10, Greece

Location

University of Florence

Florence, Italy

Location

Hospital de Santo Antonio

Porto, Portugal

Location

Hospital Universitario la Zarzuela

Madrid, 28023, Spain

Location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stavros Gravas, MD

  Societe Internationale d'Urologie

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 25, 2017
• Study Start: April 4, 2019
• Primary Completion: January 31, 2023
• Study Completion: March 1, 2023
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

GR (1); PT (1); ES (1); TU (1); IT (1)