Comparison of Motor and Sensory Response With Interstim Stimulation
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | July 2009 |
| End Date: | February 2012 |
Comparison of Motor and Sensory Response With Interstim Stimulation for Overactive Bladder and Urgency-Frequency Syndrome
Sacral nerve stimulation (SNS) implantation is a minimally invasive procedure which has
current FDA approval for urinary urge incontinence, urgency-frequency syndrome and
non-obstructive urinary retention, and has been available in the United States since 1997.
The SNS delivers non-painful, mild electrical pulses to the sacral nerves to modulate the
reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal
voiding function. While SNS has been shown to have efficacy for the aforementioned
conditions, the exact mechanism of action is unknown, but it is believed to work primarily
through the somatic afferent system in promoting inhibitory reflex pathways to facilitate
urine storage. The degree of stimulation is thought to be at a level that only evokes a
sensory and not a motor response; however this has not been tested.
current FDA approval for urinary urge incontinence, urgency-frequency syndrome and
non-obstructive urinary retention, and has been available in the United States since 1997.
The SNS delivers non-painful, mild electrical pulses to the sacral nerves to modulate the
reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal
voiding function. While SNS has been shown to have efficacy for the aforementioned
conditions, the exact mechanism of action is unknown, but it is believed to work primarily
through the somatic afferent system in promoting inhibitory reflex pathways to facilitate
urine storage. The degree of stimulation is thought to be at a level that only evokes a
sensory and not a motor response; however this has not been tested.
SNS involves a two-stage procedure. The initial phase is considered the test stimulation
period where the patient is allowed to evaluate whether or not the therapy is effective in
controlling her symptoms. There are two techniques that exist in performing the test
stimulation. The first is an office-based procedure termed the percutaneous nerve evaluation
(PNE). This involves placing a temporary electrode wire through the S3 sacral foramen under
local anesthesia. The wire is secured with tape and connected to an external generator the
patient wears for a trial period of 3-7 days. If patients have at least 50% improvement in
their symptoms during the test phase, they are candidates for chronic implant of the lead and
implantable pulse generator (IPG). The advantage of the PNE is that it is an incision free
procedure performed in the office utilizing local anesthesia, and does not require
hospitalization. The disadvantage comes from the fact that the wire is not securely anchored
in place, and has the propensity to migrate away from the nerve with physical activity. The
second alternative is known as a staged implant introduced by Spinelli in 2003 (15,16) This
is typically performed as an outpatient procedure using local anesthesia, intravenous
sedation, and intra-operative fluoroscopy. This procedure involves placement of the chronic
quadripolar lead wire adjacent to a sacral nerve root (typically S3). The lead is
self-anchoring and therefore reduces the potential for migration. The patient goes through a
test phase that can last from 7-21 days. The advantage of this technique is that it allows
for a longer trial period with minimal risk of lead migration. The chronic wire also has 4
electrodes that can each be trialed as the active electrode to achieve optimal improvement in
patients' symptoms. In addition, during the 2nd stage, or final implant the previously placed
tined-lead remains in place and is simply connected to the IPG. This eliminates the chance of
variable lead placement from the test and implantation phases. The disadvantage of the staged
implant is that it requires two visits to the operating room and may be more costly to the
health care system. However, in a prospective study comparing the PNE to the staged implant,
there was a significantly higher rate of conversion to implant with the staged procedure vs.
the PNE (88% vs.46%). In addition, infection rates are not higher with the staged implant
when compared to the PNE (17).
period where the patient is allowed to evaluate whether or not the therapy is effective in
controlling her symptoms. There are two techniques that exist in performing the test
stimulation. The first is an office-based procedure termed the percutaneous nerve evaluation
(PNE). This involves placing a temporary electrode wire through the S3 sacral foramen under
local anesthesia. The wire is secured with tape and connected to an external generator the
patient wears for a trial period of 3-7 days. If patients have at least 50% improvement in
their symptoms during the test phase, they are candidates for chronic implant of the lead and
implantable pulse generator (IPG). The advantage of the PNE is that it is an incision free
procedure performed in the office utilizing local anesthesia, and does not require
hospitalization. The disadvantage comes from the fact that the wire is not securely anchored
in place, and has the propensity to migrate away from the nerve with physical activity. The
second alternative is known as a staged implant introduced by Spinelli in 2003 (15,16) This
is typically performed as an outpatient procedure using local anesthesia, intravenous
sedation, and intra-operative fluoroscopy. This procedure involves placement of the chronic
quadripolar lead wire adjacent to a sacral nerve root (typically S3). The lead is
self-anchoring and therefore reduces the potential for migration. The patient goes through a
test phase that can last from 7-21 days. The advantage of this technique is that it allows
for a longer trial period with minimal risk of lead migration. The chronic wire also has 4
electrodes that can each be trialed as the active electrode to achieve optimal improvement in
patients' symptoms. In addition, during the 2nd stage, or final implant the previously placed
tined-lead remains in place and is simply connected to the IPG. This eliminates the chance of
variable lead placement from the test and implantation phases. The disadvantage of the staged
implant is that it requires two visits to the operating room and may be more costly to the
health care system. However, in a prospective study comparing the PNE to the staged implant,
there was a significantly higher rate of conversion to implant with the staged procedure vs.
the PNE (88% vs.46%). In addition, infection rates are not higher with the staged implant
when compared to the PNE (17).
Inclusion Criteria:
- You are eligible to participate in this study if:
- you are at least 18 years of age or older
- you have the capacity to give informed consent
- you are currently implanted with a functioning Interstim device for the treatment
of urge urinary leakage or overactive bladder
Exclusion Criteria:
- You are not eligible to participate in this study if:
- you do not meet the inclusion criteria and/or are not able to fully empty your
bladder
- you have a history of an underlying neurologic disorder
- you are currently pregnant, or have an active urinary tract or vaginal infection
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