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 and, research, market and/or approval:
“I did my research and decided I just had to live it.”
—Karina O’Malley, U.S. sociologist and educator. As quoted in the Chronicle of Higher Education, p. A5 (September 16, 1992)
“One of the most important findings to come out of our research is that being where you want to be is good for you. We found a very strong correlation between preferring the role you are in and well-being. The homemaker who is at home because she likes that “job,” because it meets her own desires and needs, tends to feel good about her life. The woman at work who wants to be there also rates high in well-being.”
—Grace Baruch (20th century)
“The only reason to invest in the market is because you think you know something others don’t.”
—R. Foster Winans (b. 1948)
“The approval of the public is to be avoided like the plague. It is absolutely essential to keep the public from entering if one wishes to avoid confusion. I must add that the public must be kept panting in expectation at the gate by a system of challenges and provocations.”
—André Breton (1896–1966)