Status:
COMPLETED
Previously Implanted Pudendal Nerve Stimulation
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Urinary Retention
Underactive Bladder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 neurostimulator...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04473469
Start Date
January 19 2021
End Date
May 2 2023
Last Update
June 3 2024
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109