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Neurostimulation Device

Pudendal Nerve Stimulation for Underactive Bladder

N/A
Waitlist Available
Led By Priyanka Gupta, M.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
Previously received an implanted neurostimulator at the pudendal nerve
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1, approximately 1 week after consent
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have previously had a device implanted to stimulate the pudendal nerve.

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

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)

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
2020
N/A
~30

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,782 Previous Clinical Trials
6,364,652 Total Patients Enrolled
2 Trials studying Urinary Retention
198 Patients Enrolled for Urinary Retention
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,677 Total Patients Enrolled
1 Trials studying Urinary Retention
22 Patients Enrolled for Urinary Retention
Priyanka Gupta, M.D.Principal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
22 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are partaking in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this research project, which was initially advertised on January 19th 2021, is presently recruiting participants. A total of 10 individuals must be sourced from a single trial site."

Answered by AI

Are there any available slots still open to participants for this investigation?

"As evidenced by clinicaltrials.gov, this study is still accepting applications. It was first published on January 19th 2021 and has undergone revisions as recently as August 19th 2022."

Answered by AI
~1 spots leftby Mar 2025