Collaborative Applied Research

Registry Studies

The feasibility and acceptability of a (mobile) application for men with LUTS/BPH: a pilot study (ClinicalTrials.gov ID: NCT03228485, uCARE 2018-002)

Primary sponsorsSociété Internationale d'Urologie
Secondary sponsors (if any)
Overall study statusOngoing
Recruitment statusRecruiting

Descriptive Information

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 (General Practitioners 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 general practitioners in supporting healthcare improvement for LUTS/BPH with use of an (mobile) application.

Note: In the time of COVID-19, patients who are already under treatment are given the opportunity to participate in the study. The patient can be informed about the study during their phone consultation.

Study objectives

Primary objective:

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.

 

Secondary objectives:

1.  To capture medical adherence using electronic reminders.

2.  To record  if  treatment  provided  by  physicians  is  in  compliance  with  the  guidelines recommendations.

3.  To evaluate the communication between physicians  and supervising urologists

Medical conditionBenign prostatic hyperplasia
Study populationThe population will be men, age ≥ 40 yrs, presenting at their physician’s office with LUTS/BPH symptoms and are either: a) treatment naïve for LUTS/BPH or b) under medical treatment.
Treatment typeObservational
Primary outcome measures

1.Feasibility of a mobile application for LUTS. The feasibility is assessed by the application use of patients. 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%).

[Time Frame: 6 months]

Secondary outcome measures

1. 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. [Time Frame: 6 months]

2. Medication adherence. Self-reported medication adherence by the patient via the application over the full period of the pilot. [Time Frame: 6 months]

3. 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. [Time Frame: At baseline]

4. Referral network
Evaluation of the referral communication between the physicians and the supervising urologist by questions in the final questionnaire.
[Time Frame: At the end of the 6 months period]

Recruitment Information

Date of first enrollment2019-04-04
Study start date2019-04-01
Estimated study completion date2021-04-10
Estimated primary completion date2021-04-01
Eligibility

Please see inclusion and exclusion criteria below.

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

-      Male

-      Age ≥ 40

-     Bothersome LUTS

-     No previous LUTS/BPH invasive treatment (medical or invasive)

-     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

 

Note: COVID-19 related considerations

If new or ongoing participants show symptoms consistent with COVID-19 or have tested positive using a test consistent with the institutional standard of care, the study participation should be evaluated as per local health authority instructions to ensure safety of the patient.

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

-     Previous LUTS/BPH treatment with medication or 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 Facility Contact
TitleMs.
First nameChristine
Last nameAlbino
Telephone+1-514-465-0367
Email[email protected]
Overall Study Officials
First nameStavros
Last nameGravas
DegreeMD, PhD, FEBU
Organizational affiliationUniversity Hospital of Larissa and Institute for Monitoring of Urogenital Diseases
Official's roleStudy Director

Centers/Contacts

Greece - Leader
NameStavros Gravas, MD, PhD, FEBU
Spain - Leader
NameIgnacio Moncada, MD
Portugal - Leader
NameVitor Cavadas, MD
Italy - Leader
NameMauro Gacci, MD
Turkey - Leader
NameJean de la Rosette, MD, PhD
Turkey
NameSelcuk Guven, MD, PhD

Publications/Documents

Publication statusPending
If other, please specify
Publication link
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