Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03228485
• Other study ID #: uCARE-2018-002
• Status: Active, not recruiting
• Start date: April 4, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Société Internationale d'Urologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 30, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• MyBPH Care mobile app
The application that will give daily medication reminders and via which the questionnaires can be filled out.

Locations

Country	Name	City	State
Greece	University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases	Larissa
Italy	University of Florence	Florence
Portugal	Hospital de Santo Antonio	Porto
Spain	Hospital Universitario la Zarzuela	Madrid
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Société Internationale d'Urologie

Countries where clinical trial is conducted

Greece,  Italy,  Portugal,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptability and satisfaction of a mobile application for LUTS	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
Secondary	Medication adherence	Self-reported medication adherence by the patient via the application over the full period of the pilot.	6 months
Secondary	Compliance to guidelines	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
Secondary	Referral network	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