Evaluations allow patients to try InterStim™ therapy to assess its efficacy so they can make an educated decision with their physician about whether to proceed with implantation. In general, the evaluation is successful if the patient experiences a significant (50% or greater) reduction in symptoms.
The basic evaluation (also referred to as peripheral nerve evaluation or PNE) is typically used to evaluate patients with bladder control problems. It is initiated through a simple, in-office procedure, during which the lead is placed in the upper buttock.
This lead connects to an external neurostimulator (ENS) that the patient wears on a belt. For approximately 3-7 days (depending on physician guidance) the patient completes a symptom diary that is eventually compared to a baseline (established by using a symptom diary prior to the evaluation).
The advanced evaluation (also referred to as Stage 1) is initiated through an outpatient procedure performed in a hospital or surgical center.
The patient also wears an ENS during the advanced evaluation, which lasts up to 14 days (depending on physician guidance). Symptom diaries are used to measure results.
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.
Goldman et al. International Continence Society best practice statement for use of sacral neuromodulation; Neurourology and Urodynamics 2018;1-26
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan® device, see the MRI SureScan® technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website
For applicable products, consult instructions for use on www.medtronic.com/manuals.
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