Posted on Mar 3, 2015 3:14:00 PM by Rebecca Anderson

Urgent PC By the Numbers – Remarkable Results

PTNS Success Statistics

Patients suffering from overactive bladder (OAB) often have a hard time finding helpful treatments – Urgent PC By the Numbers particularly ones that work over the long term. Research points to Urgent PC as an extremely effective option for difficult OAB cases. While patient frustration and failure are common with the first- and second-line OAB treatments – behavior modification and medications – Urgent PC is different. Studies show significant results and few side-effects for Urgent PC patients, especially compared to other third-line treatments. In the first article of our new series, Urgent PC By the Numbers, we’ll look into the studies that show how Urgent PC provides remarkable results.

The Urgent PC Neuromodulation System delivers percutaneous tibial nerve stimulation therapy (PTNS) to OAB patients by sending mild electrical impulses up the tibial nerve to the sacral nerves, which are responsible for pelvic floor function and voiding. Dr. Scott MacDiarmid, a urologist who specializes in treating patients with OAB, says PTNS is an excellent form of treatment but thinks it’s dramatically underused.

Waiting for Results

Unfortunately, around 80 percent of OAB patients won’t find relief with OAB medications. Reasons for this can vary. Some patients just cannot tolerate certain OAB mediations, or they are taking a lot of medications already. Affordability is another concern. Limited income or insurance might make it difficult for patients to afford the medications. Contraindications are concerning as well. Narrow-angle glaucoma, gastric or urinary retention, and existing cognitive changes must be ruled out in order for patients to take these medications. Even when medications help, many patients discontinue use within the first year, either because of limited improvement, or irritating side-effects. 

When first and second-line therapies fail, patients can turn to AUA/SUFU-recommended third-line therapies to treat OAB including Urgent PC, BOTOX injections and sacral neuromodulation. However, Urgent PC is a third-line therapy option that gives patients hope without severe side-effects.

Consider the studies:

Urgent PC vs. Drugs

The OrBIT Trial (Overactive Bladder Innovative Therapy Trial) compared Urgent PC efficiency to drug tolterodine ER. During the 12-week study, both groups saw significant reductions in urgency, frequency, urge incontinence, urge severity, and nighttime voids.

In addition, significantly more Urgent PC patients reported improvement, and constipation and dry mouth were reported significantly less in the Urgent PC patients compared to the OAB drug patients.

Meta-Analysis

Systematic reviews of the OAB literature show consistent success for PTNS. 

The meta-analysis conducted by Burton et al. found a pooled subjective success rate of 61.4 percent across four studies, and a pooled objective success rate of 60.6 percent across seven PTNS studies. 

MacDiarmid and Staskin performed a meta-analysis of seven studies, involving 244 patients, and found:

  • Voids per day improved 23 percent
  • Voids per night improved 41 percent
  • Voiding volume improved 43 percent
  • Incontinence episodes improved 45 percent 

Urgent PC vs. Sham

Urgent PC patients showed superior results compared to sham patients in the Study of Urgent PC vs. Sham Effectiveness in the Treatment of Overactive Bladder Symptoms (SUmiT Trial). While placebo patients hit plateaus after six treatments, Urgent PC patients continued to improve from treatments 7-12.

  • Patients who used PTNS showed significant improvement in bladder symptoms: 54.5 percent reported moderately or markedly improved responses from baseline compared to 20.9 percent of sham subjects.
  • PTNS outperformed Sham by more than 30 percent after 13 weeks when comparing urgency, frequency and urge incontinence. Urgent PC is effective, and it’s not because of a placebo effect. Adverse affects were also mild and infrequent with Urgent PC.

It’s worth noting that it is unusual to conduct placebo trials for medical devices, in part because, placebo effects are higher for medical device interventions than for drugs. Outperforming sham by such high rates is significant.

Effective for all age groups

Urgent PC is also effective across age groups. In a secondary analysis of the SUmiT Trial data, around 60 percent of Urgent PC patients saw overall improvement. The study did not find any significant difference in age groups.

Urgent PC patients whose symptoms were markedly or moderately improved

Symptom

 ≥65 years

 <65 years

Overall

 59%

 58%

Urgency

 36%

 50%

Frequency

 43%

 52%

Urge Incontinence

 36%

 40%

Sixty-eight percent of male patients were markedly or moderately improved with Urgent PC treatment versus just 5 percent for men using Sham. Another analysis showed Urgent PC patients had significant improvements in frequency, urgency, and urge incontinence, and trend toward a significant decrease in nighttime voids.

Urgent PC Helps

If patients are not finding help for OAB with other treatments, Urgent PC is an effective treatment. With Urgent PC, patients saw improvements with daily voids, incontinence episodes and in overall quality of life. Age is no obstacle either, since there is no difference in success between age groups. With Urgent PC treatment, most patients see improvement by the sixth treatment but some respond later. It’s a long process, but encourage patients to finish the initial 12-treatment series before they decide if it’s helpful for them. 

In the second article of our series, Urgent PC by the numbers, we’ll compare side-effects among various OAB treatments.

Urgent PC eBook CTA

BOTOX is a registered trademark of Allergan, Inc.

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. 

Rebecca Anderson
Rebecca Anderson has been a marketer in the healthcare industry for over fifteen years, the last ten of which have been focused on Urgent PC and other products from Cogentix Medical. Rebecca has a special fondness for Urgent PC, having been part of the Uroplasty team that launched the product to U.S. and International markets.
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