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)
“The research on gender and morality shows that women and men looked at the world through very different moral frameworks. Men tend to think in terms of “justice” or absolute “right and wrong,” while women define morality through the filter of how relationships will be affected. Given these basic differences, why would men and women suddenly agree about disciplining children?”
—Ron Taffel (20th century)
“the old palaces, the wallets of the tourists,
the Common Market or the smart cafés,
the boulevards in the graceful evening,
the cliff-hangers, the scientists,
and the little shops raising their prices
mean nothing to me.”
—Anne Sexton (1928–1974)
“I am thankful to God for this approval of the people. But while deeply grateful for this mark of their confidence in me, if I know my heart, my gratitude is free from any taint of personal triumph. I do not impugn the motives of any one opposed to me. It is no pleasure to me to triumph over any one.”
—Abraham Lincoln (1809–1865)