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NCT04473469 Clinical Trial

Previously Implanted Pudendal Nerve Stimulation

Urinary Retention Clinical Trial

Official title:
Previously Implanted Pudendal Nerve Stimulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04473469
Other study ID # HUM00180124
Secondary ID OT2OD028191
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2021
Est. completion date May 2, 2023

Study information
Verified date December 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date May 2, 2023
Est. primary completion date May 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Medtronic Interstim II Model 3058 Neurostimulator
Patients will undergo stimulation of the pudendal nerve. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)
Lead Sponsor Collaborator
University of Michigan National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evoked bladder contractions of at least 20 centimeters of water (cmH2O) At least 50% of participants Visit 1, approximately 1 week after consent
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