Pudendal nerve mapping towards improved neuromodulation for urinary retention
Project Number1OT2OD028191-01
Contact PI/Project LeaderBRUNS, TIMOTHY M.
Awardee OrganizationUNIVERSITY OF MICHIGAN AT ANN ARBOR
Description
Abstract Text
Our targeted medical condition is detrusor underactivity, a bladder problem in
which individuals are unable to effectively empty their bladder. This is a widespread clinical
problem that receives far less attention than overactive bladder and incontinence conditions. We
propose to use neuromodulation of the pudendal nerve, with the Medtronic Interstim implantable
neurostimulator, to evaluate stimulation-driven voiding in patients that are receiving the
stimulator as a treatment for bladder problems. We expect that this study represents a low level
of risk. Although we are studying an implant, the Interstim device is approved by the FDA for the
conditions under study and we are already implanting the device at this location, in an off-label
use. We will use imaging and electrophysiology to map the pudendal nerve in ten patients
receiving the implant. Next, we will create patient-specific computational models of the implant
and nerve, allowing us to simulate optimal stimulation paradigms for recruiting bladder excitation
pathways in the pudendal nerve. These optimal paradigms will be evaluated in a follow-up test
session with patients in which we will seek to drive bladder voiding responses. The final two
participants in this study will have detrusor underactivity, allowing us to evaluate whether our
approach works in the target patient group. Our study outcomes will include demonstrating
successfully-driven bladder contractions and voiding, creating validated patient-specific
computational models of pudendal nerve stimulation, and mapping pudendal nerve anatomy.
Figure 1 shows our overall study design, with example figures of our anticipated study
progression as implemented for another neuromodulation approach by our team [1].
A primary objective of the SPARC program is to enhance knowledge of anatomical and
functional neural innervation of autonomic organs towards improved neuromodulation therapies.
We believe our project aligns perfectly with this objective, as we will use imaging and
electrophysiology techniques to map a key nerve innervating pelvic organs in a relevant clinical
population. A principal outcome of the entire SPARC program will be a model for simulating a
user-selected neuromodulation therapy on an end organ. Our plan to perform patient-specific
modeling of pudendal nerve neuromodulation directly aligns with this program outcome, and
may integrate directly within that simulator.
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