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.
Read more about this topic: Percutaneous Tibial Nerve Stimulation
Famous quotes containing the words research, market and/or approval:
“The working woman may be quick to see any problems with children as her fault because she isn’t as available to them. However, the fact that she is employed is rarely central to the conflict. And overall, studies show, being employed doesn’t have negative effects on children; carefully done research consistently makes this clear.”
—Grace Baruch (20th century)
“At market and fair, all folks do declare,
There is none like the Boy that sold Broom, green Broom.”
—Unknown. Broom, Green Broom (l. 23–24)
“Consult. To seek another’s approval of a course already decided on.”
—Ambrose Bierce (1842–1914)