Comparison of Motor and Sensory Response With Interstim Stimulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Noblett, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00943904
First received: July 20, 2009
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Overactive Bladder
Urgency-Frequency
Device: Interstim implant for SNS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Comparison of Motor and Sensory Response With Interstim Stimulation for Overactive Bladder and Urgency-Frequency Syndrome

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Improvement in overactive bladder and urgency frequency syndrome. [ Time Frame: 6 months following enrollment ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interstim stimulation
Patients who receive the interstim implant in order to evaluate effectiveness of treatment
Device: Interstim implant for SNS
stimulates third sacral nerve root
Other Name: Sacral nerve Stimulation

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943904

Locations
United States, California
UCI Women's Healthcare
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen Noblett, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Karen Noblett, Division Director, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00943904     History of Changes
Other Study ID Numbers: 2009-6799
Study First Received: July 20, 2009
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
urinary leakage associated with urinary urgency
unable to fully empty bladder
Comparison: Motor&Sensory Response to Interstim Stimulation

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014