Prostatic HyperplasiaNCT03228485
Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study
An observational study of Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Société Internationale d'Urologie at 5 sites in 5 countries.
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). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- MyBPH Care mobile app
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 4 Apr 2019to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male
- Age ≥ 40
- Bothersome LUTS
- Start of medical therapy for LUTS
- Either:
- No previous LUTS/BPH treatment (medical or invasive), or
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Greece1 site
University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases
Larissa, 10
About this study
Official title: The Feasibility and Acceptability of a (Mobile) Application for Men With LUTS/BPH: a Pilot Study
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.
Read the 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.
- Being tested
- MyBPH Care mobile app
- Keywords
- Smartphone, Application, Pilot, mhealth
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyBPH Care mobile appDevice
The application that will give daily medication reminders and via which the questionnaires can be filled out.
| Study group | Role | What they receive |
|---|---|---|
| MyBPH Care | All patients enrolled in this study. Receives: Device: MyBPH Care mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 6 months
Medication adherence
Self-reported medication adherence by the patient via the application over the full period of the pilot.
Measured: 6 months
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.
Measured: At baseline
Referral network
Evaluation of the referral communication between the physicians and the supervising urologist by questions in the final questionnaire.
Measured: At the end of the 6 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start4 Apr 2019
- Primary completion31 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Internationale d'Urologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stavros Gravas, MD, Study chair, Societe Internationale d'Urologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228485
- Sponsor's protocol ID
- uCARE-2018-002
- Status last verified
- May 2025
- First submitted
- 20 Jul 2017
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Acceptability of a (Mobile) Application for Men With LUTS/BPH: a Pilot Study
- ClinicalTrials.gov ID
- NCT03228485
- Acronym / sponsor ID
- uCARE-2018-002
- Keywords
- Smartphone, Application, Pilot, mhealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Société Internationale d'UrologieUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyBPH Care | – | Device: MyBPH Care mobile appAll patients enrolled in this study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Male
- Age ≥ 40
- Bothersome LUTS
- Start of medical therapy for LUTS
- Either:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyBPH Care mobile appThe application that will give daily medication reminders and via which the questionnaires can be filled out. | Device | MyBPH Care |
Primary outcome
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%).
4 secondary outcomes
Acceptability and satisfaction of a mobile application for LUTS
Time frame: 6 months
Medication adherence
Time frame: 6 months
Compliance to guidelines
Time frame: At baseline
Referral network
Time frame: At the end of the 6 months period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros Gravas, MD study chair
Societe Internationale d'Urologie
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Société Internationale d'Urologie at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Greece, Italy, Portugal, Spain, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a mobile application for LUTS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025; AzTrials last refreshed its copy on 29 Oct 2026.