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Neurostimulation Device

Pudendal Nerve Stimulation for Underactive Bladder

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1, approximately 1 week after consent
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at how different frequencies of pudendal nerve stimulation affect the bladder in patients who already have a pudendal nerve stimulator implanted.

Eligible Conditions
  • Urinary Retention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1, approximately 1 week after consent
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1, approximately 1 week after consent for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram
Secondary study objectives
Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP)
Selective Stimulation of Pudendal Nerve Branches

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CystometrogramExperimental Treatment1 Intervention
The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medtronic Interstim II Model 3058 Neurostimulator
2021
N/A
~10

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,812 Previous Clinical Trials
8,161,466 Total Patients Enrolled
1 Trials studying Urinary Retention
22 Patients Enrolled for Urinary Retention
University of MichiganLead Sponsor
1,853 Previous Clinical Trials
6,433,012 Total Patients Enrolled
2 Trials studying Urinary Retention
198 Patients Enrolled for Urinary Retention
Tim Bruns, Ph.D.Principal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
49 Total Patients Enrolled
1 Trials studying Urinary Retention
22 Patients Enrolled for Urinary Retention

Media Library

Medtronic Interstim II Model 3058 Neurostimulator (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04473469 — N/A
Urinary Retention Research Study Groups: Cystometrogram
Urinary Retention Clinical Trial 2023: Medtronic Interstim II Model 3058 Neurostimulator Highlights & Side Effects. Trial Name: NCT04473469 — N/A
Medtronic Interstim II Model 3058 Neurostimulator (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04473469 — N/A
~1 spots leftby Nov 2025
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