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Welcome tothe NOVASTIM study: Non-invasive Stimulation Therapy for Overactive Bladder: A Randomized Controlled Trial.
The purpose of this study is to help researchers who are hard at work developing new treatments for OAB. This study is being conducted to verify that saphenous nerve stimulation with the NiNA device is non-inferior to the use of medication in reducing the number of daily urgency urinary incontinence episodes
The NOVASTIM app is a proprietary platform of ObvioHealth being used to manage a trial tocollect data regarding changes in OAB symptoms of participants.Changes in OAB symptoms will be measured at appropriate study time points using the following instruments: Bladder diary (3-day), OAB-q and other self-administered questionnaires. Additional assessments of subject satisfaction and preferences will be obtained via subject study surveys and questionnaires at various study time points.
The NOVASTIM app will allow for ease of reporting on behalf of participant and gives direct communication to study team support for users without delay. By creating an opportunity to study the changing symptoms through self-administered questionnaires and instruments, it increases accessibility to participation while reducing overhead costs of physical sites.
The result? Robust data collection, increased compliance, faster time to completion, andaverage cost savings of ~50% vs. traditional on-site trials.
Once deemed eligible, the participant will receive an email with the NOVASTIM download link and their login ID.
Upon download, the participants create a OAB CDUT account and complete the InformedConsent process. A series of screens explains the parameters of the study, including:
•Privacy Policy
•Data Gathering & Usage
•Study Tasks & Surveys
•Time Commitment
•Option to Withdraw
Subjects will have the opportunity to connect with a member of the study team to ask questions prior to signing the informed consent form.
They will go on to complete three electronic questionnaire to further verify eligibility and collect demographics. After this is done, there will be an a 60-minute interview where the participant will be asked about their experiences with the app and main bladder diary.There are no risks involved in this study because it involves a phone interview and an in-app electronic questionnaire.