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NCT Number: NCT03228485

Benign Prostatic Hyperplasia (BPH) Mobile Application 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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases, Larissa, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

MyBPH Care mobile app

Device

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

Primary outcomes

  1. 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%).

Secondary outcomes

  1. 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.

  2. Medication adherence

    Time frame: 6 months

    Self-reported medication adherence by the patient via the application over the full period of the pilot.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Société Internationale d'Urologie

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2017
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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