Patient Education & Consent
Patient Instructions
Prior to placement of the temporary lead, the patient completes a voiding diary (ideally at least 3 days).
After placement of the temporary lead, the patient should be instructed to avoid bending, stretching, or lifting heavy objects during the initial trial period to decrease the chance of wire dislodgment. The patient completes another voiding diary of several days’ duration while undergoing treatment.
The patient’s response to treatment is compared to the baseline voiding diary. If the change in symptoms is 50% or greater, he or she is a candidate for placement of the permanent stimulator.
Once implanted, the neurostimulator is activated. The physician will initially program the device and adjust the stimulator to optimize therapy. The patient will also be instructed on how to adjust the intensity of the pulse stimulation. The patient needs to understand that the therapy is “dynamic” and that, over time, adjustments in the pulse intensity and frequency may be necessary to optimize the clinical response. A programmer manual and video are available to educate patients on patient-controlled programming and stimulation adjustments.
The patient must be educated on the warnings and precautions regarding use of the device and activities and other devices which may interfere or be affected by the device (see Precautions and Warnings).
Elements of Informed Consent
Informed consent should be obtained for both the trial period and placement of the permanent device. Patients should be aware of the risks as noted in Other Adverse Effects. Furthermore, although determination of a successful test period (≥50% improvement in symptoms) enhances the likelihood of a positive outcome with placement of the permanent device, it is not a guarantee.
Equipment
Placement of the temporary lead may be performed with or without fluoroscopy. However, placement of the permanent lead and programmer should be performed with the use of fluoroscopy. A surgical instrument set and suture material is needed for placement of the permanent stimulator.
Patient Preparation
An improvement in symptoms of 50% or greater is recommended prior to placement of the permanent stimulator. Since the placement of the stimulator is a surgical procedure, the same considerations would apply to placement of the programmer as other surgical procedures regarding the use of aspirin, anti-inflammatories, and blood thinners.
Anesthesia
For the test phase, local anesthetic is used. Implantation of the permanent device is performed in the operating room under anesthesia.
Positioning
The patient is placed in a prone position for implantation.
Monitoring & Follow-up
Once implanted, the neurostimulator is activated. The physician initially programs the device and adjusts the stimulator to optimize the therapy for each patient. The patient will also need instructions so that he or she may adjust the intensity of the stimulation. Once an optimal strength and intensity of pulse stimulation has been determined, the patient can modulate the stimulator for maximal response.
Periodic follow-up, usually every 6-12 months, is recommended to monitor the therapy’s effectiveness.
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Figure depicts lead entering sacral foramen and Interstim device in place. Image reprinted with permission from Medtronic, Inc
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lead exiting back
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IPG being placed in subcutaneous pocket right buttock
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Incision for placement of implantable neurostimulator.
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Incision closed with neurostimulator in place.
