Phase
Condition
Genitourinary Prolapse
Urinary Incontinence
Enuresis
Treatment
Medtronic Interstim II Model 3058 Neurostimulator
Participants received a Neurostimulator, which was used to map the pudendal nerve
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Clinically referred as having bladder problems that have not responded to conservative treatment. Normal clinical care includes referral to implant of Medtronic Interstim neurostimulator at the pudendal nerve. Fully eligible to receive an Interstim implant.
Adult (18 or older), capable of providing own informed consent and communicating clearly with research team
Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English
Capable of attending all experimental sessions (Visit 1: pre-stage-1 imaging, Visit 2: stage-1 surgery, Visit 3: CT after stage-2 surgery, Visit 3: cystometrogram test)
Exclusion
Implanted materials that prohibit magnetic imaging
Any medical problems that prevent an individual from laying flat in an MRI or CT scanner, are are claustrophobic.
Areflexive or atonic bladder
Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy.
Diagnosed neurogenic bladder, pudendal nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition.
Unwilling to allow de-identified data to be stored for future use or shared with other researchers.
Study Design
Study Description
Connect with a study center
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
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