Let’s face it. On paper, PTNS with the Urgent PC system doesn’t seem like the most logical choice. The clinician inserts a needle near a patient’s ankle, attaches a stimulator, and turns it on for 30 minutes. Repeat one time a week for 12 weeks, and presto, change-o you have a better bladder?
Sure there’s science behind it, and there are countless positive clinical publications showing consistent clinical performance of up to 80%, but the company needed something to show, once and for all, that the improvement wasn’t all in patients’ heads.
The Placebo Factor
Everyone knows that the mind is a powerful thing and, often times, just thinking something makes it so. That certainly happens with some drugs and medical devices, which explains why blind trials are valuable – to filter out any results created by the power of suggestion.
Measuring the placebo factor requires treating some patients with sham devices or fake pills, and comparing the results with patients who are treated with the real device or drug. The placebo effect is well-documented, especially in the treatment of overactive bladder. In fact, one meta-analysis found a 41% improvement/cure rate in subjects in placebo groups compared to a 56% improvement/cure rate in the active OAB drug treatment groups.
Urgent PC is unique in that it is a medical device that is so minimally-invasive and low-risk that you can actually do a Sham comparative study. The result was the Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) trial.
Urgent PC vs Sham
According to the study, Urgent PC results were superior to the Sham, an unusual and compelling result for a medical device. In particular, the study found:
- 54.5% of Urgent PC patients reporting 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)
- Urgent PC patients had statistically significant objective improvements in frequency (p=0.01), nighttime voids (p=0.04), voids with moderate to severe urgency (p<0.0001) and urinary urge incontinence episodes (p=0.002) compared to sham (voiding diaries)
- No serious device-related adverse events or malfunctions were reported.
- Level 1 evidence that 12 weeks of Urgent PC therapy provides patients with OAB clinically and statically significant symptom improvement compared to validated sham.
SUmiT was an institutional review board-approved, double-blind, randomized, sham-controlled trial. The landmark study involving 220 participants was conducted across 23 geographically diverse clinical centers in the United States. It reinforced the strong, compelling performance of PTNS when delivered via the Urgent PC device. Furthermore, SUmiT concluded that Urgent PC therapy should be considered a viable treatment for OAB symptoms.
Urgent PC Data
For medical professionals, it is compelling to note that Urgent PC is the only PTNS device that boasts substantial clinical results in over 50 studies. In addition, Urgent PC system was used exclusively in all of the major clinical studies, including:
- Overactive Bladder Innovative Therapy (OrBIT) Trial
- OrBIT Trial 12 Month Study
- Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation (STEP)
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 © 2015 Cogentix Medical. All rights reserved.