About the Therapy Sacral neuromodulation

PROVEN TREATMENT OPTION FOR BLADDER CONTROL AND BOWEL CONTROL

Sacral Neuromodulation is a proven treatment option for bladder control and bowel control. More than 225,000 patients worldwide have received Sacral Neuromodulation for Bladder Control and Bowel Control.*

Sacral Neuromodulation is delivered via the InterStim™ system. The implanted neurostimulator and lead electrically stimulate the sacral nerve which is thought to normalize neural communication between the bladder and brain1 and between the bowel and brain2. Unlike oral medications that target the muscular component of bladder control, Sacral Neuromodulation offers control of symptoms through direct modulation of the nerve activity.1,2

A distinct advantage of Sacral Neuromodulation delivered by the InterStim system is that it is tested for potential success prior to moving on to long-term therapy. The evaluation gives patients and physicians an opportunity to find out in as few as 3 to 7 days whether adequate symptom reduction is achieved.

The most common adverse events experienced during clinical studies of patients with Sacral Neuromodulation included pain at implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations. Any of these may require additional surgery or cause return of symptoms. See Indications, Safety, and Warnings for additional safety information.


HOW IT WORKS

S3 in the pelvic floor

The InterStim system for Bladder Control and Bowel Control helps to control symptoms of overactive bladder, non-obstructive urinary retention, and chronic fecal incontinence through direct modulation of the nerve activity.

The InterStim system electrically stimulates the sacral nerve which is thought to normalize neural communication between the bladder and brain1 and between the bowel and brain.2


SACRAL NEUROMODULATION FOR BLADDER CONTROL

Not all patients benefit from standard medical therapy.3-4 Standard pharmacological therapy for OAB consists of administering anti-cholinergic medications, which mainly treat the efferent limb of the micturition reflex (muscular activity).5

While anti-cholinergic drug therapy may alleviate OAB symptoms for some patients, they are not effective for everyone. More than 70% of patients stop taking medications within six months due to side effects and/or lack of efficacy.3 Furthermore, some of these medications may cause intolerable side effects for patients.3,4

While anticholinergic drugs address the muscle component in bladder control, Sacral Neuromodulation addresses the nerve component.1, 5 Medtronic Sacral Neuromodulation is thought to help normalize neural activity from the bladder to the brain, enabling patients to experience improved urinary function.1, 7, 8

Sacral Neuromodulation offers effective bladder control and proven efficacy in some patients for whom more conventional intervention has been unsatisfactory.6 Leading theories of mechanism of action suggest that Sacral Neuromodulation works by modulating neural communication traveling between the bladder and brain enabling patients to experience restored urinary function.1, 7


SACRAL NEUROMODULATION FOR BOWEL CONTROL

Not all patients benefit from conservative treatment options such as medication, diet modification, and exercise. Sacral Neuromodulation is a minimally invasive option that can restore bowel function. Sacral Neuromodulation for Bowel Control is effective, safe, and may offer patients improved quality of life.9


KEY COMPONENTS OF THE INTERSTIM SYSTEM

Sacral Neuromodulation System Components
  • Tined lead is placed parallel to the sacral nerve (targeting S3).
  • Implantable neurostimulator generates mild electrical pulses that are delivered through the lead electrodes.
  • Clinician and patient programmers are used to set the parameters of the electrical pulses.

TWO TYPES OF EVALUATION

The evaluation allows patients to try the therapy and assess not only its efficacy but also its tolerability and sensation so that they and their physician can make an educated decision whether or not to proceed with an InterStim system implant. In general, the evaluation is considered a success if the patient experiences a significant reduction in his or her bladder control or bowel control symptoms.

There are two types of evaluation for Sacral Neuromodulation, delivered by the InterStim system: the basic evaluation and the advanced evaluation. Either one can be used to test Sacral Neuromodulation for Bladder Control or Bowel Control. In both evaluations, a portable, external stimulator generates the stimulation which is delivered via a lead; the patient wears this stimulator throughout the evaluation. Patients complete a symptom diary prior to the evaluation to establish a baseline measure of incontinence; and during the evaluation to measure improvement.

The basic evaluation (also referred to as Peripheral Nerve Evaluation or PNE) is initiated through a simple, in-office procedure. The advanced evaluation (also referred to as Stage 1) is initiated through an outpatient procedure performed in a hospital or surgical center. Both evaluations are short-term, and the effects are reversible by removing the leads or turning off the device.

Complications can occur with the evaluation, including movement of the wire, technical problems with the device, and some temporary pain. Patients should be instructed on operating the test device and given other precautions related to the evaluation as well as activity restrictions.


*

Data from InterStim Sales Analysis. Medtronic, Inc. October 2016.

Restored function with the InterStim™ system is defined as ≥50% reduction in dysfunctional voiding symptoms from baseline.


1

Johnson M. Transcutaneous electrical nerve stimulation (TENS). Published online Oct 15, 2012.

2

Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. Br J Surg. 2013;100:959–968.

3

Yeaw J, Benner J, Walt JG et al. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009:15(9):724-736.

4

Haab F, Castro-Diaz D. Persistence with antimuscarinic therapy in patients with overactive bladder. Int J Clin Pract. 2005;59(8):931-937.

5

Hashim H, Abrams P. Drug treatment of overactive bladder: efficacy, cost and quality-of-life considerations. Drugs. 2004;64:1643-1656.

6

Noblett K, Siegel S, Mangel J et al. Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at 12 months in subjects with symptoms of OAB. Neurourol Urodyn. 2014. doi:10.1002/nau.22707.

7

Chancellor MB, Chartier-Kastler EJ. Neuromodulation. 2000;3(1):16-26.

8

Leng WW, Chancellor MB. Urol Clin N Am. 2005;32:11-18.

9

Hull T, Giese C, Wexner SD, Mellgren A, Devroede G, et al. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013;56:234–245.