Over the past decade, Cogentix Medical has worked to make Urgent PC, and Percutaneous Tibial Nerve Stimulation (PTNS), a proven part of the overactive bladder (OAB) algorithm of care. Urgent PC has evolved over the years, and continues to prove the science behind its technology.
Since its creation, thousands of healthcare providers have supported us through this process by delivering well over 1-million treatments.
History of Urgent PC
The history of PTNS starts about 30 years ago with Dr. Marshall Stoller, from UCSF Medical Center, San Francisco, who initiated a 10-year period of patient study applying intermittent PTNS culminating in a patent issued in 1993 for a method of using a needle electrode for PTNS.
In 1999, Dr. Fred Govier, et al, from UCSF Medical Center, expanded on Stoller’s data by initiating a multi-center prospective of safety and efficacy study of PTNS for OAB. In that same year, CE Mark was issued for the first PTNS device with FDA clearance following the next year, in 2000. While the PTNS data was solid, the technology struggled to find adoption until 2004 when Cogentix Medical, previously known as Uroplasty, acquired the Urgent PC technology.
Since Cogentix acquired the technology, we’ve made strides in advancing the technology and awareness of this treatment. In 2005, Cogentix updated the Urgent PC technology and obtained 510(k) clearance for the Urgent PC stimulator and lead set. Then in 2006, Cogentix developed the next generation of Urgent PC featuring a new control interface and an ergonomic design.
Investing in Clinical Data
But it took more than a pretty face, and an updated interface, to make Urgent PC and PTNS a recognized part of the algorithm of care for OAB sufferers. For one thing, providers weren’t convinced of its clinical efficacy. For another, there was no established reimbursement.
From 2007 – 2009 the company conducted multiple randomized studies to compare Urgent PC to drug and sham treatments, including a SUmiT Trial, Overactive Bladder Innovative Therapy (OrBIT) Trial, OrBIT Trial 12 Month Study, and Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation (STEP) study.
Creating Change in Overactive Bladder Care
Armed with solid clinical data, Cogentix and Urgent PC advocates had what was needed to influence changes in the treatment of OAB.
One part was the inclusion of PTNS into the AUA/SUFU OAB guideline as a recommended treatment for patients refractory to behavioral and drug therapies. This milestone was a great affirmation of the validity of the Urgent PC clinical data and its place as an important treatment for OAB.
But perhaps an even greater accomplishment was the strides Cogentix made in securing reimbursement for the procedure. In August 2014, the company was able to proudly announce that Medicare would reimburse for Urgent PC therapy nationwide. This meant that the 48 million Medicare beneficiaries would now have access to the only non-drug, and non-surgical, third-line therapy for OAB!
Cogentix has also achieved many major milestones with private payers, Urgent PC currently has market access to the majority of private payers. For more information, visit the Urgent PC Coverage Finder.
A History of Success
PTNS has come a long way since 1987, and Urgent PC continues to be the first PTNS treatment for patients suffering with OAB. After years of studies on its validity, refining its design, and developing its technology, the current Urgent PC is now a recommended procedure in the AUA/SUFU guideline and is a procedure that’s reimbursed by Medicare and numerous private payers.
Urgent PC is indicated for the treatment of Overactive Bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence. Treatment with Urgent PC is contraindicated for patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function or patients who are pregnant or planning to become pregnant during the duration of the treatment. Most patients don't experience side-effects. If side-effects occur, they are typically temporary and include mild pain and skin inflammation at or near the stimulation site. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For complete instructions for use, storage, warnings, indications, contraindications, precautions, adverse reactions and disclaimer of warranties, please refer to the insert accompanying each product or online at www.cogentixmedical.com. Urgent PC is a registered trademark of Cogentix Medical © 2016 Cogentix Medical. All rights reserved.