SNM (Sacral Neuromodulation) is a well-established therapy for subjects with Urinary and Fecal dysfunction. To date, over 200,000 subjects worldwide have received InterStim® SNM implants.
Axonics Sacral Neuromodulation Therapy for Urinary Control is indicated for the treatment of the symptoms of Urinary Urgency Incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.
The primary objective is to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of Urinary Urgency Incontinence (UUI) designed to gain pre-market approval in the United States.
To be eligible for the project you must have:
Diagnosis of Urinary Urgency Incontinence (UUI) demonstrated on a 72-hour voiding diary defined as:
- a minimum of four (4) leaking episodes associated with urgency,
- at least 50% of all leaking episodes associated with urgency, and
- at least one leaking episode each 24-hour period.
Greater than or equal to 6 months’ history of UUI diagnosis
For male subjects only:
- Peak flow rate > 15 cc/s as verified by uroflowmetry within 6 months prior to enrollment
- Residual bladder volume < 150 cc tested within 6 months prior to enrollment
- Positive motor response on at least two (2) implanted electrodes during intraoperative test in the S3 (preferred) or S4 foramen
21 years of age and older
Failed conservative therapy and second-line drug therapy and is not a candidate for additional conservative or second-line therapy
No changes to current regimen of medications that affect bladder function for at least four (4) weeks prior to beginning the baseline voiding diary and baseline questionnaires
Willing and capable of providing informed consent
Capable of participating in all testing associated with this clinical investigation