Previously Implanted Pudendal Nerve Stimulation

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    University of Michigan
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Updated on 5 August 2020
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Summary

This study seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators.

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, bowel, and sexual problems, and pelvic pain. Researchers do not fully understand how the nerve helps with these functions or how the anatomy is different between people. Successful stimulation of the pudendal nerve may help improve medical care for future patients with bladder problems, pelvic pain, bowel problems, and/or sexual problems.

Details
Condition Urinary Retention, Underactive Bladder
Age 18years - 100years
Treatment Medtronic Interstim II Model 3058 Neurostimulator
Clinical Study IdentifierNCT04473469
SponsorUniversity of Michigan
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Previously received an implanted neurostimulator at the pudendal nerve
Adult (18 or older), capable of providing own informed consent and communicating clearly with the research team
Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English
Capable of attending the experimental session

Exclusion Criteria

Pregnant or planning to become pregnant during study. If a woman of child- bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy
Currently has a urinary tract infection (UTI)
Currently has or tested positive in the last 14 days for COVID-19, or is symptomatic for COVID-19
Unwilling to allow de-identified data to be stored for future use or shared with other researchers
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