Comparison of Motor and Sensory Response With Interstim Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00943904
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : July 22, 2013
Information provided by (Responsible Party):
Karen Noblett, University of California, Irvine

Brief Summary:
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 or disease Intervention/treatment Phase
Overactive Bladder Urgency-Frequency Device: Interstim implant for SNS Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement in overactive bladder and urgency frequency syndrome. [ Time Frame: 6 months following enrollment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00943904

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

Responsible Party: Karen Noblett, Division Director, University of California, Irvine Identifier: NCT00943904     History of Changes
Other Study ID Numbers: 2009-6799
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by Karen Noblett, 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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms