CAUTION-Investigational Device. Limited by Federal or U.S. law to investigational use
Guardian StUDY FOR OVERACTIVE BLADDER (OAB)
Now Actively Recruiting
Protect PNS is being studied for the treatment of urgency urinary incontinence associated with OAB for patients who have failed pharmaceutical treatment. OAB is characterized by symptoms including urgency, frequency, nocturia and often with a leakage of urine.
Eligibility
General Qualifications for Participation in the Guardian Study:
(for a complete description, please speak with your Clinical Study Investigator)
- ≥ 18 years of age
- Diagnosis of OAB with or without urgency urinary incontinence
- Average urinary frequency > 8-times per 24-hr day based on a 3-day voiding diary
- Self-reported bladder symptoms present > 3-months
- Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, medications etc.)
- Ambulatory and able to use a toilet independently, without difficulty
Study Participation
As a participant in this clinical study you can expect the following:
(for a complete description, please speak with your Clinical Study Investigator)
- Visit #1 will be to learn about the study and confirm participation
- Visit #2 will focus on securing baseline health data
- Visit #3 is reserved for implantation of the device
- Visit #4 and #5 will be follow-up visits 2 and 4 weeks apart, respectively
- Total of 13 visits will be completed to assess progress during the trial
Study site Locations
We are adding new sites around the country on a weekly basis. Please contact us below for more information for a study site near you.