Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

Last updated: July 26, 2024
Sponsor: University of Michigan
Overall Status: Completed

Phase

N/A

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

NCT04236596
HUM00165005
OT2OD028191
  • Ages > 18
  • All Genders

Study Summary

This study is to map the pudendal nerve. In this study the researchers will examine subjects who are already receiving an implanted stimulator at their pudendal nerve as part of their normal clinical care.

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

Total Participants: 22
Treatment Group(s): 2
Primary Treatment: Medtronic Interstim II Model 3058 Neurostimulator
Phase:
Study Start date:
September 14, 2020
Estimated Completion Date:
June 08, 2023

Study Description

The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical stimulation of this nerve can help with bladder problems and pelvic pain. Researchers do not understand how the nerve anatomy is different between people. Successfully mapping the pudendal nerve may help improve the medical care for future patients with bladder problems, pelvic pain, bowel problems, and sexual problems.

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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