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Neuromodulation Device
Pudendal Nerve Stimulation for Urinary Retention
N/A
Waitlist Available
Led By Tim Bruns, Ph.D.
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2: stage-1 (approximately 3 weeks after consent)
Awards & highlights
Study Summary
This trial will help researchers map the pudendal nerve, which will help patients who receive implanted pudendal nerve stimulators as part of their clinical care.
Eligible Conditions
- Urinary Retention
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have bladder problems that haven't improved with usual treatments and you may be considered for a specific type of implant for nerve stimulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 2: stage-1 (approximately 3 weeks after consent)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2: stage-1 (approximately 3 weeks after consent)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evoked bladder contractions of at least 20 centimeters of water (cmH2O) during the stage-4 test
Secondary outcome measures
Selectivity index for selective stimulation of pudendal nerve branches for patient stimulation
Selectivity index for selective stimulation of pudendal nerve branches for simulated model stimulation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Medtronic Interstim II Model 3058 NeurostimulatorExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medtronic Interstim II Model 3058 Neurostimulator
2020
N/A
~30
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,794 Previous Clinical Trials
6,373,894 Total Patients Enrolled
2 Trials studying Urinary Retention
181 Patients Enrolled for Urinary Retention
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,566 Total Patients Enrolled
1 Trials studying Urinary Retention
5 Patients Enrolled for Urinary Retention
Tim Bruns, Ph.D.Principal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
45 Total Patients Enrolled
1 Trials studying Urinary Retention
5 Patients Enrolled for Urinary Retention
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that affects the nerves controlling urination.You have a medical condition that makes it hard for you to lie flat in an MRI or CT scanner, or you feel very uncomfortable in small, enclosed spaces."Exclusion" means that you are not allowed to participate in the study.You have a bladder that does not respond normally to signals.You have implanted materials that can't be used during a magnetic imaging test.You have bladder problems that haven't improved with usual treatments and you may be considered for a specific type of implant for nerve stimulation.
Urinary Retention Patient Testimony for trial: Trial Name: NCT04236596 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for prospective participants to join this trial?
"According to the details on clinicaltrials.gov, this medical research project is currently recruiting participants. It was first announced in September 2020 and updated recently in November 2022."
Answered by AI
How many participants are being enrolled in this research endeavor?
"Affirmative, according to clinicaltrials.gov the trial is currently recruiting participants. It was published on September 14th 2020 and last updated November 3rd 2022. This medical study requires 20 patients from a single facility."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Chronic urinary retention. Self cathing for the past 6 months due to infection and inability to void predictably. Currently infection free, but still need to self cath.
PatientReceived 1 prior treatment
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