Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

May 14, 2025 updated by: Société Internationale d'Urologie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of a mobile application for LUTS
Time Frame: 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability and satisfaction of a mobile application for LUTS
Time Frame: 6 months
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
Time Frame: 6 months
Self-reported medication adherence by the patient via the application over the full period of the pilot.
6 months
Compliance to guidelines
Time Frame: At baseline
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
Time Frame: At the end of the 6 months period
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société Internationale d'Urologie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Stavros Gravas, MD, Societe Internationale d'Urologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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