Skip to main content
Case Study

Overactive Bladder Case Study

Genito Urinary
Men's/Women's Health
Download the PDF

Objective

To evaluate the safety and efficacy of a novel medical device for the treatment of OAB, and test multiple versions of the device's companion app to determine how to best drive compliance to maximize device efficacy.

Methodology

This is a 52-week at-home, randomized, active control study comparing the device to the current Rx standard of care. Patients will complete screening/enrollment during a home visit from a study nurse.

Over the duration of the study, the ObvioHealth app collects efficacy and safety data that the COACH team will monitor in real-time and proactively address to mitigate safety and compliance concerns.

FDA submission will include valuable data substantiating that the device and companion app is capable of delivering real-world results superior to Rx alone.

Case Study

Overactive Bladder Case Study

Genito Urinary
Men's/Women's Health
Studying a medical device for the treatment of overactive bladder. ObvioHealth is conducting an innovative study seeking FDA approval of a wearable neuromodulation device for the treatment of overactive bladder (OAB).
Download the PDF

Objective

To evaluate the safety and efficacy of a novel medical device for the treatment of OAB, and test multiple versions of the device's companion app to determine how to best drive compliance to maximize device efficacy.

Methodology

This is a 52-week at-home, randomized, active control study comparing the device to the current Rx standard of care. Patients will complete screening/enrollment during a home visit from a study nurse.

Over the duration of the study, the ObvioHealth app collects efficacy and safety data that the COACH team will monitor in real-time and proactively address to mitigate safety and compliance concerns.

FDA submission will include valuable data substantiating that the device and companion app is capable of delivering real-world results superior to Rx alone.

Case Study

Overactive Bladder Case Study

Genito Urinary
Men's/Women's Health
Download the PDF

Objective

To evaluate the safety and efficacy of a novel medical device for the treatment of OAB, and test multiple versions of the device's companion app to determine how to best drive compliance to maximize device efficacy.

Methodology

This is a 52-week at-home, randomized, active control study comparing the device to the current Rx standard of care. Patients will complete screening/enrollment during a home visit from a study nurse.

Over the duration of the study, the ObvioHealth app collects efficacy and safety data that the COACH team will monitor in real-time and proactively address to mitigate safety and compliance concerns.

FDA submission will include valuable data substantiating that the device and companion app is capable of delivering real-world results superior to Rx alone.

Case Study

Overactive Bladder Case Study

Genito Urinary
Men's/Women's Health
Download the PDF

Objective

To evaluate the safety and efficacy of a novel medical device for the treatment of OAB, and test multiple versions of the device's companion app to determine how to best drive compliance to maximize device efficacy.

Methodology

This is a 52-week at-home, randomized, active control study comparing the device to the current Rx standard of care. Patients will complete screening/enrollment during a home visit from a study nurse.

Over the duration of the study, the ObvioHealth app collects efficacy and safety data that the COACH team will monitor in real-time and proactively address to mitigate safety and compliance concerns.

FDA submission will include valuable data substantiating that the device and companion app is capable of delivering real-world results superior to Rx alone.

Case Study

Overactive Bladder Case Study

Genito Urinary
Men's/Women's Health
Download the PDF

Objective

To evaluate the safety and efficacy of a novel medical device for the treatment of OAB, and test multiple versions of the device's companion app to determine how to best drive compliance to maximize device efficacy.

Methodology

This is a 52-week at-home, randomized, active control study comparing the device to the current Rx standard of care. Patients will complete screening/enrollment during a home visit from a study nurse.

Over the duration of the study, the ObvioHealth app collects efficacy and safety data that the COACH team will monitor in real-time and proactively address to mitigate safety and compliance concerns.

FDA submission will include valuable data substantiating that the device and companion app is capable of delivering real-world results superior to Rx alone.

Case Study

Overactive Bladder Case Study

Studying a medical device for the treatment of overactive bladder. ObvioHealth is conducting an innovative study seeking FDA approval of a wearable neuromodulation device for the treatment of overactive bladder (OAB).

Genito Urinary
Men's/Women's Health
Download the PDF

Objective

To evaluate the safety and efficacy of a novel medical device for the treatment of OAB, and test multiple versions of the device's companion app to determine how to best drive compliance to maximize device efficacy.

Methodology

This is a 52-week at-home, randomized, active control study comparing the device to the current Rx standard of care. Patients will complete screening/enrollment during a home visit from a study nurse.

Over the duration of the study, the ObvioHealth app collects efficacy and safety data that the COACH team will monitor in real-time and proactively address to mitigate safety and compliance concerns.

FDA submission will include valuable data substantiating that the device and companion app is capable of delivering real-world results superior to Rx alone.

Back to Top
Case Study

Overactive Bladder Case Study

Studying a medical device for the treatment of overactive bladder. ObvioHealth is conducting an innovative study seeking FDA approval of a wearable neuromodulation device for the treatment of overactive bladder (OAB).

Genito Urinary
Men's/Women's Health
Download the PDF

Objective

To evaluate the safety and efficacy of a novel medical device for the treatment of OAB, and test multiple versions of the device's companion app to determine how to best drive compliance to maximize device efficacy.

Methodology

This is a 52-week at-home, randomized, active control study comparing the device to the current Rx standard of care. Patients will complete screening/enrollment during a home visit from a study nurse.

Over the duration of the study, the ObvioHealth app collects efficacy and safety data that the COACH team will monitor in real-time and proactively address to mitigate safety and compliance concerns.

FDA submission will include valuable data substantiating that the device and companion app is capable of delivering real-world results superior to Rx alone.

Discover More Case Studies

Discover More News

Discover More White Papers

Discover More Blogs

Discover More Playbooks

Discover More Webinars

Discover More Events

Infectious Disease

COVID-19 Case Study: Monitoring Patients Remotely Using Digital Devices

ObvioHealth successfully conducted a clinical trial for RedHill Biopharma to test the safety and efficacy of an oral medication for the treatment of COVID-19 symptoms. We designed this decentralized study to be conducted where the majority of patients recover from illness—in their homes. When the trial was launched in 2021, its unique combination of home health visits, electronic patient-reported outcomes (ePRO), and remote monitoring devices was pioneering—COVID-19 studies were typically conducted inside hospitals.

› Read More
Genito Urinary

The First-Ever Fully Virtual Clinical Trial in Urogynecology

ObvioHealth and Renovia conducted a groundbreaking study on the efficacy of an at-home medical device for the treatment of stress and mixed urinary incontinence. Read more below to understand how we delivered a successful, fully virtual clinical trial in the midst of the pandemic.

› Read More