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Clinical Trials/NCT03228485
NCT03228485
Completed
Not Applicable

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

Société Internationale d'Urologie5 sites in 5 countries200 target enrollmentApril 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostatic Hyperplasia
Sponsor
Société Internationale d'Urologie
Enrollment
200
Locations
5
Primary Endpoint
Feasibility of a mobile application for LUTS
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2019
End Date
March 1, 2023
Last Updated
11 months ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Bothersome LUTS
  • Start of medical therapy for LUTS
  • 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

Outcomes

Primary Outcomes

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

  • Acceptability and satisfaction of a mobile application for LUTS(6 months)
  • Medication adherence(6 months)
  • Compliance to guidelines(At baseline)
  • Referral network(At the end of the 6 months period)

Study Sites (5)

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