Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

NCT ID: NCT03228485

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-04

Study Completion Date

2023-03-01

Brief Summary

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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.

Detailed Description

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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

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Prostatic Hyperplasia Lower Urinary Tract Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MyBPH Care

All patients enrolled in this study.

MyBPH Care mobile app

Intervention Type DEVICE

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

Interventions

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MyBPH Care mobile app

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Société Internationale d'Urologie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stavros Gravas, MD

Role: STUDY_CHAIR

Societe Internationale d'Urologie

Locations

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University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases

Larissa, , Greece

Site Status

University of Florence

Florence, , Italy

Site Status

Hospital de Santo Antonio

Porto, , Portugal

Site Status

Hospital Universitario la Zarzuela

Madrid, , Spain

Site Status

Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Greece Italy Portugal Spain Turkey (Türkiye)

Other Identifiers

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uCARE-2018-002

Identifier Type: -

Identifier Source: org_study_id

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