Neuromodulators, also called electrical nerve stimulators, use mild electrical pulses to stimulate the nerves in the lower back, alleviating pain and improving urinary function. Neuromodulators are proving helpful for Interstitial Cystitis (IC) patients who are not getting enough relief from other treatments.
Some neuromodulators are worn externally, while others are surgically implanted devices. The majority of implanted neuromodulators work by sending mild electrical pulses to the sacral nerves in the lower back. The sacral nerves influence the bladder and the surrounding muscles that control urinary function. Prior to surgically implanting a neuromodulator, usually in the lower back, a stimulation test procedure is conducted. Patients are only considered for permanent implants when they respond positively to the test stimulator. In the remainder of this blog post, we will learn more about neuromodulation therapies for people with IC.
Types of FDA Approved Neuromodulators for Urinary Symptoms and Pain
There are a number of neuromodulators approved by the FDA to treat symptoms of IC. For additional resources, patients can ask their health care provider if there are any clinical trials researching implementing neuromodulators to treat IC that could be beneficial to them.
Urgent PC: The Urgent PC Neuromodulation System, also referred to as percutaneous tibial nerve neuromodulation (PTNS), is a combination of a lead set and a stimulator. This system was created to treat urinary frequency, urinary urgency, and urge incontinence. The stimulator generates a mild electrical impulse that is administered to the patient via the lead set. Utilizing a needle electrode positioned near the ankle as an entrance point, the stimulator’s impulses migrate along the tibial nerve to the nerves in the spine that manage pelvic floor function. The needle electrode is attached to a battery-powered stimulator. After turning on the stimulator, the doctor will monitor the patient’s reaction to identify the ideal intensity of the impulses.
Each treatment takes approximately half an hour and the initial sequence is 12 treatments that are generally scheduled a week apart. After a dozen preliminary treatments, the doctor will discuss the patient’s reaction to the therapy and ascertain how frequently they will need future treatments to preserve their results. For most patients, it requires at least half a dozen treatment sessions to observe improvements in their symptoms. However, we urge patients to proceed with their prescribed dozen treatments before they evaluate with their doctor whether or not this therapy is an effective treatment for their IC symptoms.
The most prevalent side-effects include temporary slight pain or skin inflammation near the stimulation area. This therapy isn’t recommended for patients with pacemakers/ implantable defibrillators, patients with nerve damage that could affect either percutaneous tibial nerve or pelvic floor function, patients prone to excessive bleeding, as well as patients who are pregnant or intending to become pregnant during the span of the therapy.
A study entitled, Posterior Tibial Nerve Stimulation in Patients with Intractable Interstitial Cystitis, found that of the 14 IC patients that participated in the study, 13 completed the 10 weeks of treatment with no complications. Furthermore, 12 out of 14 of the participants resumed treatment for a short period of time after the research concluded. Although there were no statistically substantial improvements in overall pain scores, voiding frequency/volumes, or in the ICPI/ICSI/SF-36 results. Nevertheless, there was remission in some patients, with one patient reporting a complete resolution of the pain.
InterStim Therapy for Urinary Control: This medical device is FDA approved for urinary urge incontinence, nonobstructive urinary retention, and significant symptoms of urgency-frequency in patients who have failed to respond to, or could not endure more conservative therapies. Some IC patients report that InterStim also helped relieve their pain, along with their symptoms of urinary urgency and frequency. However, it’s important to note that it has not yet been approved by the FDA for pain management.
Patients interested in surgical implants are initially assessed by their comprehensive medical history, a physical examination, their voiding journal, and performing a bladder function study. If the patient qualifies, they receive a short test stimulation from a urologist or urogynecologist. The test stimulation entails placing a needle into the lower back in a position where nerves move to the bladder. A lead (small wire) is positioned to transmit electrical impulses to the nerves that control the bladder. The patient goes home shortly after the test simulation with instructions to keep the test stimulator in position and to keep a voiding journal. After 3-7 days, the lead is then extracted by the doctor. Some patients have reported that the test stimulation was painful, while others reported little to no pain. If you are concerned about pain, please discuss pain management options with your doctor. Usually, local anesthesia is utilized during the test stimulation.
If the test stimulation is effective, and symptom improvement is noted within 5-7 days, then the permanent system can be surgically implanted with a general anaesthetic. This procedure typically requires an overnight stay in the hospital after implantation. After surgery, the patient is provided with a small remote that can be utilized to turn the device on/off and regulate the level of stimulation to nerves. This device can only be implanted by a urologist or urogynecologist who has been specially trained to execute this procedure.
IF 3WAVE: This device has been authorized by the FDA to be prescribed to treat pain, when combined with other forms of therapy, affiliated with IC. The IF 3WAVE is utilized to heal deep discomfort by transmitting nearly 50 times the strength of a TENS unit. It transmits two distinct variations of current; neuromuscular electrical stimulation (NMES) and pulses direct current (PDC) as well as a combination of both of these currents. This device features a digital screen, user-friendly pushbuttons, and a compliance monitor for monitoring utilization of the device.
If you are an IC patient who wants additional resources or if you’re concerned that you might have a gynecological problem that is undiagnosed, please contact Mangrove Women’s Health at (530) 345-0064, extension 281 to set up an appointment.