Urinary incontinence and overactive bladder are medical conditions where the
patient either has frequent urges to urinate (urinary urgency-frequency), the inability to
urinate despite the feelings of a full bladder (urinary urge incontinence) or the inability to
completely empty the bladder (urinary retention). These conditions affect around 72
million people in North America and around 348 million people world wide. The patient
population breakdown is around 72% female and 28% male.1
Many options are available for treating urinary incontinence. These include
incontinence pads to absorb unintentional voiding episodes, physical therapy,
pharmacologic drug therapy, surgical interventions such as urethral slings and sacral
nerve stimulation (SNS). Most patients proceed from pads and physical therapy to drugs
and finally nerve stimulation. InterStim is the only FDA approved neurostimulation
system currently on the market for treating urinary urge incontinence, urinary urgencyfrequency
and non-obstructive urinary retention.2 The therapy consists of an implantable
neurostimulator (INS) and an associated lead which delivers the electrical stimulation
from the INS to the target sacral nerve. One aspect for successful application of SNS
therapy is using a foramen needle to locate the S3 sacral foramen and place the lead
electrodes adjacent to the S3 sacral nerve.
The activities documented in this thesis centered on the collection of sacral anatomy data as a design input for the evaluation of a lead implant template for use in
locating the S3 foramen. The project hypothesis is “Will the use of a lead implant
template help to improve the efficacy for locating the S3 foramen when implanting a
Sacral Nerve Stimulation lead for treating urinary incontinence?". The project was split
into two primary studies. The first half of the project centered on an anatomical study of
the morphological variation in dry bone sacrum and cadavers. The anatomical study was
intended to quantify the amount of variation that needs to be accommodated by the
implant template. The second half of the project centered on the efficacy evaluation of
the prototype template.
University of Minnesota M.S. thesis. November 2009. Major: Integrative biology and physiology. Advisors: Stephen A. Katz, Ph. D.,Kenneth P. Roberts, Ph. D., Anthony J. Weinhaus, Ph. D. 1 computer file (PDF); x, 47 pages, appendices A-C.
Stetz, Eric Michael.
A study of the sacral anatomy and its implications on the development of a guide to improve the efficacy of locating the S3 Foramen for implantation of a sacral nerve stimulation lead..
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