Research and Market Approval
The methodology was first invented by Dr. Marshall Stoller at UCSF Medical Center, San Francisco, and was first known as the SANS protocol.
In 2000, Dr. Stoller reported that 98 patients were treated with the SANS device with an approximate 80% success rate in treating urge incontinence syndrome, including urgency and frequency. In a corroborative multi-center study by Govier, et al., 71% of patients achieved success. Additionally, in a study by Shafik, et al., 78% of patients achieved a long-term improvement in faecal incontinence when treated with PTNS.
Regulatory clearances were based on these data. A PTNS device received FDA-clearance for urinary urgency, urinary frequency and urge incontinence in 2000; in 2010, the clearance was updated to include Overactive Bladder (OAB). A PTNS device received the CE mark for urinary urgency, urinary frequency and urge incontinence and fecal incontinence in 2005.
Since 2005, Uroplasty has marketed the Urgent PC Neuromodulation System, the only PTNS device commercially available today.
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