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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

Challenge

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.

Solution

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

Challenge

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.

Solution

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

Challenge

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.

Solution

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

Challenge

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.

Solution

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

Challenge

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.

Solution

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).

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

Challenge

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.

Solution

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.

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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

Challenge

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.

Solution

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.

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