Posted on Apr 5, 2016 11:31:00 AM by Cogentix Medical

Clinical Proof: Urgent PC is THE Proven PTNS

If you were to propose to me a treatment that included putting a needle into my ankle to treat my Tried, Trusted, and True: Urgent PC is the Proven PTNSoveractive bladder (OAB), I would be skeptical. However, as they say, “the proof is in the pudding.” The proof of the Urgent PC Neuromodulation System spans across 50 peer-reviewed studies over the past 20 years and demonstrates that percutaneous nerve stimulation (PTNS) is an effective, low risk, and preferred treatment for OAB patients. Based on this clinical record, Urgent PC has been established to be the go-to PTNS treatment for OAB.

A Summary of Urgent PC Clinical Results

In Urgent PC clinical studies, including the randomized control trials by Peters and Finazzi-Argò, up to 80% of patients respond to PTNS treatment with substantial decreases in urgency, frequency, and urge incontinence. In addition, recent meta-analysis from MacDiarmid and Burton reinforce a high average response rate.

Urgent PC is Superior to Sham

Urgent PC versus Sham? The results are in and a comparative study that included 220 participants within 23 geographically different clinics in the U.S. demonstrated that the improvements provided by Urgent PC are not due to a placebo effect.  54.5% of Urgent PC patients reported moderate or marked improvements in bladder symptoms compared to 20.9% of sham subjects (p<0.001). Urgent PC patients demonstrated statistically significant subjective improvements compared to sham (urinary urgency – p=0.003, urinary frequency – p<0.001, urinary urge incontinence – p=0.02) (patient GRA). These results allowed the authors to conclude that Urgent PC therapy should be considered a viable treatment for OAB symptoms.

Urgent PC Compared to Drugs

A randomized trial for PTNS versus the extended-release tolterodine was favorable to PTNS therapy, especially in subjective response to therapy where 79.5% of patients reported cure or improvement, compared to the 54.8% of subjects given tolterodine as a treatment (p= 0.01).  Objective measures improved similarly in both groups for reductions in urinary frequency, urge urinary incontinence episodes, urge severity and nighttime voids, as well as for improvement in voided volume. 

Urgent PC Compared to 3rd Line Treatments

Medication is usually the first option provided to OAB sufferers but as you know, only a minority of patients find long-term success with drug therapy. Fortunately for your patients, there are several 3rd-line therapies recommended for the treatment of OAB, including Sacral Neuromodulation (SNM), onabotulinumtoxin A (Botox), and PTNS (Urgent PC). A recent study aimed to discover which treatment was preferred by patients, and PTNS came out on top.

When comparing these options, researchers discovered that 81% of the patients who had experience with OAB medications were willing to try all three 3rd-line treatments. However, after rating them, 98% of the participants expressed a willingness to try PTNS therapy, and 57% preferred the PTNS approach over the other two therapies. Using best-worst scaling (BWS), OAB patients reported that the implant required by SNM, and the delivery of the botulinum toxin, via the urethra, were seen as negatives by respondents. For PTNS, the BWS ratings viewed the regularly scheduled visits as negatives, but the “needle inserted in ankle,” and “minimal side effects” were viewed as positives.

Urgent PC History of Safety

As far as Urgent PC side-effects goes, there are minimal effects. Even in the very early clinical studies, Urgent PC delivered excellent results with very little risk. In the Investigational Device Exemption (IDE) study, 14-percent of patients had side-effects but all of them were transient and non-serious. In more recent studies, we’ve seen even lower rates of side-effects.

With over 50 studies indicating safety, efficacy, and preference, Urgent PC is the proven PTNS device for treating patients who are suffering with OAB.

Urgent PC eBook CTA

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. 

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