PTNS Has No Severe Side-Effects
Although there are many treatment options for overactive bladder patients, the side-effects can outweigh the improvements. One notable exception is Urgent PC Therapy, which is low-risk and has few contraindications. Since the majority of patients are not helped by behavior therapy and drug treatment, it’s important to compare not only patient outcomes but also side-effects when considering the next line of therapy. A host of studies demonstrate how Urgent PC provides a great balance of strong improvement rates along with limited side-effects. In the second article of our series, Urgent PC By The Numbers, we look at how Urgent PC fares in a side-effect comparison with other treatments.
How Does Urgent PC Work?
The Urgent PC Neuromodulation System delivers Percutaneous Tibial Nerve Stimulation Therapy (PTNS), a low-risk, office-based treatment for OAB. During treatment, a slim 34-gauge needle electrode is temporarily placed at a 60-degree angle near the ankle. Using an external stimulator, mild impulses are sent via the electrode along the tibial nerve to the nerves responsible for bladder and pelvic floor function. The stimulation level is set for each treatment, based on the patient’s comfort level.
Urgent PC is much less invasive than the other third-line therapies – onabotulinumtoxinA injections into the bladder muscle or a neurostimulation device surgically implanted in the buttock.
Side-Effects in Clinical Studies
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 minor:
We’ve seen even lower rates of side-effects in more recent studies, including the The SUmiT Trial (Study of Urgent PC vs. Sham Effectiveness in the Treatment of Overactive Bladder), STEP study (Sustained Therapeutic Effect of Percutaneous Tibial Nerve Stimulation), and the OrBIT study (Overactive Bladder Innovative Therapy Trial):
Urgent PC Side-Effects in IDE, SUmiT and OrBIT trials
|Mild pain at stimulation site||0-6%|
|Swelling – leg or foot||0-6%|
|Mild bleeding – needle site||0-4%|
|Moderate pain – stimulation site||1-4%|
|Inflammation – needle site||0-3%|
|Bruising – needle site||0-2%|
Twenty years of experience with Urgent PC has refined the approach and may have contributed to better outcomes with reduced risk. What hasn’t changed is the severity of the side-effects. With more than 50 studies published, there has never been a report of a severe adverse event related to Urgent PC.
Side-Effect Comparison from the AUA/SUFU OAB Guideline
The American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) OAB Treatment Guideline recommend PTNS, intradetrusor onabotulinumtoxinA injections, and sacral neuromodulation (SNS) as third-line therapies for OAB, after behavior therapy and medications. The side-effects listed in those guidelines are instructive.
Regarding PTNS adverse events, the AUA/SUFU Guideline states: “Reported adverse events were minor; the most frequently reported events were painful sensation during stimulation that did not interfere with treatment and minor bleeding at the insertion site.” With the other third-line therapies, the lists in the AUA/SUFU Guideline are longer and the adverse events more severe.
For intradetrusor onabotulinumtoxinA, the Guideline reports, “outcomes occurred…in the context of high adverse events in the active treatment groups in some studies.” Listed side-effects include:
- Urinary retention
- PVR increase
- Need for self-catheterization
- Dry mouth
- Gross hematuria
- Urinary retention
- Eyelid weakness
- Arm or leg weakness
- Torso weakness
- Impaired vision
For SNS, the Guideline notes, “in contrast to PTNS studies…SNS studies reported frequent adverse events…” Among them:
- Pain at the stimulator site
- Pain at the lead site
- Lead migration
- Electric shock
- Need for surgical revision
Compare and Contrast
Transient mild pain or skin inflammation at or near the stimulation site are the most common side-effects associated with PTNS treatment. UTIs and retention are the most common moderately serious adverse side-effects for intradetrusor onabotulinumtoxinA injections with BOTOX®. SNS with InterStim® has high reoperation and failure rates up to 35 percent, and reoperation for a battery change is 100 percent. And long-term use of OAB medications is becoming more of a concern. We know that more than 80% of patients will discontinue their drugs within the first year due to side-effects. And, now there’s compelling evidence that long-term use of anticholinergics increases the risk of incident dementia and Alzheimer Disease. With these concerns on the table, Urgent PC is an excellent treatment option with minimal side-effects.
In the final two articles of our series, Urgent PC By the Numbers, we will look at reimbursement codes and patient treatment schedules.
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. Models are for illustrative purposes. Urgent is a registered trademark of Cogentix Medical © 2015 Cogentix Medical. All rights reserved.