Case Study

Overactive Bladder Case Study

Genito Urinary
Men's/Women's Health

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).

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

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

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

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

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

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

When older DCT subjects are more compliant than their

ObvioHealth recently completed the first-ever fully virtual urogynecology study to evaluate a medical digital intravaginal device for female stress urinary incontinence. In this randomized trial, pelvic floor muscle contractions were monitored.

350

Participants in 
14 weeks

350

Participants in 
14 weeks
*$67 Per Participant