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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 belowSelect...
You have previously had a device implanted to stimulate the pudendal nerve.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 1, approximately 1 week after consent
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1, approximately 1 week 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)
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a urinary tract infection (UTI).You have previously had a device implanted to stimulate the pudendal nerve.
Research Study Groups:
This trial has the following groups:- Group 1: Cystometrogram
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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