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Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

S

Société Internationale d'Urologie

Status

Completed

Conditions

Lower Urinary Tract Symptoms
Prostatic Hyperplasia

Treatments

Device: MyBPH Care mobile app

Study type

Observational

Funder types

Other

Identifiers

NCT03228485
uCARE-2018-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

MyBPH Care
Description:
All patients enrolled in this study.
Treatment:
Device: MyBPH Care mobile app

Trial contacts and locations

5

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Central trial contact

Jean de la Rosette, MD, PhD; Stavros Gravas, MD

Data sourced from clinicaltrials.gov

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