Overactive BladderOABNCT04534946
A Pilot Study Evaluating the Usability of the Oabi Mobile Application
An observational study of Overactive Bladder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Our primary purpose is to assess the use feasibility and acceptability of the study phone app called, "Oabi" app with patients diagnosed with overactive bladder disorder (OAB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- This is not an intervention study
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 31 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a primary diagnosis of overactive bladder disorder
Who may be able to join
- Patients with a primary diagnosis of OAB (with active OAB symptoms) with or without urge incontinence who are:
- Treatment-naive patients who started a new treatment within two weeks prior to the study enrollment
- Transitioning to another treatment (pharmacotherapy)
- Transitioning from behavioral therapy to pharmacotherapy
- Adults aged 18 yrs and above.
- Own a Smartphone with Android Operating System with an OS of 5.0 or higher or willing to use a study phone as their primary for the duration of the study (Samsung Galaxy S6).
Show all 9Show fewer
- Sufficient understanding of the English language to be able to read and understand study procedures.
- Willing to participate in the research study and sign informed consent.
- Has adequate access to the internet to use the app.
Who cannot join
- Subjects unable or unwilling to participate for at least three months.
- Subjects with vision, hearing, and/or speech problems that may limit their participation in data collection procedures.
- Subjects with physical limitations that limit may their ability to use a Smartphone, effectively navigate a Smartphone app, and type on a Smartphone.
- Participants with the history of urological surgery or those currently using a urinary sling.
- Participants on botox treatment for OAB.
- Participants with OAB symptoms due to coexisting conditions such as urinary tract infection (UTI), and or benign prostatic hypertrophy (BPH).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mass General/North Shore Center
Salem, Massachusetts, 01970
About this study
Our primary purpose is to assess the use feasibility and acceptability of the study phone app called, "Oabi" app with patients diagnosed with overactive bladder disorder (OAB).
Read the detailed description
Tracking overactive bladder disorder can be an important part of managing the disease. It can help the patient and the health care providers keep a tab on what is working to help manage OAB symptoms. Tracking urination patterns can actually help patients normalize their bladder problems. By focusing on certain behaviors and habits that contribute to their OAB and changing those behaviors, patients can effectively control OAB symptoms. The Oabi mobile application has been created with the goal of helping patients learn more about their day-to-day symptoms as well as track and self-manage their symptoms. Additionally, the Oabi app connects patients with their HCP via a clinician portal to boost communication, and encourage patient-provider interaction. The goal of this pilot study is to evaluate the usability and acceptability of the Oabi mobile app.
- Conditions
- Overactive Bladder
- Being tested
- This is not an intervention study
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is not an intervention studyOther
This is not an intervention study
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobile application usability
To assess the usability and acceptability of the mobile app via post-pilot survey
Measured: 12 weeks
Secondary outcomes (1)
User application engagement
To assess participant engagement with the Oabi app, to assess provider engagement and satisfaction with the Oabi clinician portal, to assess the perceived value of the app in how it impacts the HCP-patient dialogue and patient care related to the management of OAB (qualitatively), and to gather recommendations for modifications to the Oabi app and clinician portal from users.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start20 Mar 2017
- Primary completion31 Mar 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Kamal Jethwani, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534946
- Sponsor's protocol ID
- 2016P002386
- Acronym
- OAB
- Status last verified
- Aug 2020
- First submitted
- 26 Mar 2018
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Usability of the Oabi Mobile Application
- ClinicalTrials.gov ID
- NCT04534946
- Acronym / sponsor ID
- OAB / 2016P002386
- Conditions
- Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Sep 2020 (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.
Our primary purpose is to assess the use feasibility and acceptability of the study phone app called, "Oabi" app with patients diagnosed with overactive bladder disorder (OAB).
Detailed description
Tracking overactive bladder disorder can be an important part of managing the disease. It can help the patient and the health care providers keep a tab on what is working to help manage OAB symptoms. Tracking urination patterns can actually help patients normalize their bladder problems. By focusing on certain behaviors and habits that contribute to their OAB and changing those behaviors, patients can effectively control OAB symptoms. The Oabi mobile application has been created with the goal of helping patients learn more about their day-to-day symptoms as well as track and self-manage their symptoms. Additionally, the Oabi app connects patients with their HCP via a clinician portal to boost communication, and encourage patient-provider interaction. The goal of this pilot study is to evaluate the usability and acceptability of the Oabi mobile app.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a primary diagnosis of overactive bladder disorder
Key inclusion criteria (9 listed)
- Patients with a primary diagnosis of OAB (with active OAB symptoms) with or without urge incontinence who are:
- Adults aged 18 yrs and above.
- Own a Smartphone with Android Operating System with an OS of 5.0 or higher or willing to use a study phone as their primary for the duration of the study (Samsung Galaxy S6).
- Sufficient understanding of the English language to be able to read and understand study procedures.
- Willing to participate in the research study and sign informed consent.
Key exclusion criteria (6 listed)
- Subjects unable or unwilling to participate for at least three months.
- Subjects with vision, hearing, and/or speech problems that may limit their participation in data collection procedures.
- Subjects with physical limitations that limit may their ability to use a Smartphone, effectively navigate a Smartphone app, and type on a Smartphone.
- Participants with the history of urological surgery or those currently using a urinary sling.
- Participants on botox treatment for OAB.
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 |
|---|---|---|
| This is not an intervention studyThis is not an intervention study | Other | – |
Primary outcome
Mobile application usability
Time frame: 12 weeks
To assess the usability and acceptability of the mobile app via post-pilot survey
1 secondary outcome
User application engagement
Time frame: 12 weeks
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 1 Sep 2020.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Kamal Jethwani, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Massachusetts General Hospital at 1 site in United States.
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 9 inclusion and 6 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Mobile application usability (time frame: 12 weeks). 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 1 Sep 2020.