A Pilot Study Evaluating the Usability of the Oabi Mobile Application

NCT04534946 | Completed

• 1 other identifier: 2016P002386
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Mobile application usability

  To assess the usability and acceptability of the mobile app via post-pilot survey

  12 weeks

Secondary Outcomes (1)

• User application engagement

  12 weeks

Interventions

This is not an intervention study OTHER

This is not an intervention study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a primary diagnosis of overactive bladder disorder

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Mass General/North Shore Center

Salem, Massachusetts, 01970, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kamal Jethwani, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: September 1, 2020
• Study Start: March 20, 2017
• Primary Completion: March 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)