Clinical trial NCT03228485: Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study
Official title: The Feasibility and Acceptability of a (Mobile) Application for Men With LUTS/BPH: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: Smartphone
Application
Pilot
mhealth
Lead sponsor: Société Internationale d'Urologie
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of a mobile application for LUTS
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability and satisfaction of a mobile application for LUTS
timeFrame: 6 months
measure: Medication adherence
timeFrame: 6 months
measure: Compliance to guidelines
timeFrame: At baseline
measure: Referral network
timeFrame: At the end of the 6 months period
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases
city: Florence
country: Italy
facility: University of Florence
city: Porto
country: Portugal
facility: Hospital de Santo Antonio
city: Madrid
country: Spain
facility: Hospital Universitario la Zarzuela
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Societe Internationale d'Urologie
name: Stavros Gravas, MD
role: STUDY_CHAIR
References: