- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04473469
Previously Implanted Pudendal Nerve Stimulation
December 5, 2023 updated by: Timothy Bruns, University of Michigan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mackenzie Moore, MPH
- Phone Number: 734-647-8568
- Email: mooremac@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cystometrogram
The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evoked bladder contractions of at least 20 centimeters of water (cmH2O)
Time Frame: Visit 1, approximately 1 week after consent
|
At least 50% of participants
|
Visit 1, approximately 1 week after consent
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tim Bruns, Ph.D., University of Michigan
- Principal Investigator: Priyanka Gupta, M.D., University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2021
Primary Completion (Actual)
May 2, 2023
Study Completion (Actual)
May 2, 2023
Study Registration Dates
First Submitted
July 13, 2020
First Submitted That Met QC Criteria
July 13, 2020
First Posted (Actual)
July 16, 2020
Study Record Updates
Last Update Posted (Actual)
December 7, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00180124
- OT2OD028191 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All de-identified IPD collected during the trial will be available.
IPD Sharing Time Frame
Will be available twelve months following publication of study findings, or earlier.
IPD Sharing Access Criteria
Anyone who wishes to access the data.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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