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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~visit 2: stage-1 (approximately 3 weeks after consent)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2: stage-1 (approximately 3 weeks after consent) for reporting.

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

Medtronic Interstim II Model 3058 Neurostimulator (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04236596 — N/A
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
Recent research and studies
clinicaltrials.govStudy
Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
Timothy Bruns 2020. "Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04236596.
~5 spots leftby Apr 2025
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