Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation (STEP) Healthcare professionals and researchers have long been looking for ways to blunt the debilitating effects of Overactive Bladder (OAB) syndrome. An additional challenge is finding a therapy that can work over time since Overactive Bladder is a chronic condition that requires ongoing treatment. Thankfully, Urgent® PC is up to the challenge.
STEP Study Design
To evaluate long-term effectiveness of Urgent PC, researchers embarked the study. This was a 3-year extension of the landmark SUmIT trial, a randomized, double blind, sham-controlled trial conducted across 23 geographically diverse clinical centers in the United States. One of the main objectives of the STEP Study was to evaluate how often and how many follow-up treatments may be necessary to maintain a positive clinical response. The key to the research for patients was a 3-month tapering protocol with a fixed 14-week schedule.
The STEP Study researchers focused on 50 patients who had participated in the SUmIT trial and shown marked improvement after PTNS was delivered via the Urgent PC Neuromodulation System.
Research findings demonstrate that over the entire three year research period, more than ¾ of the patients maintained moderate or marked improvement of their OAB symptoms and only one Urgent PC treatment a month was needed for follow-up maintenance. Patients maintained a decrease in how often they experienced accidents, had to use the bathroom, both during the day and at night, and suffered incontinence episodes.
For most Urgent PC patients, the therapy changed their lives and improved their quality of life. In addition, no major side-affects were reported after use of the Urgent PC device.
The STEP Study showed OAB sufferers and medical professionals that there is safe, long-term, minimally invasive, and highly effective treatment is available for this chronic condition; all provided by Urgent PC Neuromodulation Therapy.
No other PTNS device has been used in the major clinical research trials regarding OAB and nerve stimulation therapy. The extensive testing and research supported the inclusion of PTNS in treatment guidelines from the American Urological Association and other prominent medical groups.
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.