All > Urinary Retention

Sacral Neuromodulation for Overactive Bladder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic Urology/Urogynecology Department, Rochester, MNOveractive Bladder+2 MoreSacral Neuromodulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will collect signals from the body at different times to see how effective the therapy is.

Eligible Conditions
  • Overactive Bladder
  • Urinary Retention
  • Bowel Incontinence

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 1 day to 7 months

Month 7
Number of subjects with physiological signals collected at each timepoint

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
MetaWear Sensor
1
Maintenance group
3
Vibegron

Trial Design

1 Treatment Group

Pelvic health Electrically Evoked Recording (PEER) 2 Study
1 of 1

Experimental Treatment

300 Total Participants · 1 Treatment Group

Primary Treatment: Sacral Neuromodulation · No Placebo Group · N/A

Pelvic health Electrically Evoked Recording (PEER) 2 Study
Device
Experimental Group · 1 Intervention: Sacral Neuromodulation · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacral Neuromodulation
2018
N/A
~90

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 day to 7 months

Who is running the clinical trial?

MedtronicNeuroLead Sponsor
69 Previous Clinical Trials
20,473 Total Patients Enrolled
Nichole CarlsonStudy DirectorMedtronic Pelvic Health

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
People who have symptoms of overactive bladder.
You are willing and able to complete diary entries, answer questionnaires, attend visits, and follow the study's rules on your own.
You agree to keep taking your current OAB medication at the same dose and frequency throughout the study.
I'm sorry, but that is not an exclusion criterion. It is an inclusion criterion. However, I can simplify the language for you: Rewritten Inclusion Criterion: You have a condition called non-obstructive urinary retention.
You are planning to receive or are currently receiving a Medtronic InterStim lead implant for a specific medical condition that needs further evaluation.
You understand the study and agree to participate by signing a consent form.
If you have urinary urge incontinence, you must have experienced at least 3 episodes of it within the first 3 days of keeping a record. These episodes must have been accompanied by a mild, moderate, or severe sensation of needing to urinate urgently.
You experience urinary frequency and urgency at least 8 times a day, and have been diagnosed with overactive bladder (OAB).
If you have already decided with your doctor to get a Medtronic InterStim lead implant for your condition, you cannot join this study.
References

Frequently Asked Questions

Is enrollment for this trial currently open?

"Affirmative. Clinicaltrials.gov outlines that this research endeavour, which was launched on January 18th 2022, is actively seeking out participants. Approximately 300 patients need to be enrolled across 6 different medical facilities." - Anonymous Online Contributor

Unverified Answer

How many geographic sites have been identified to host this research project?

"Presently, this research endeavour is running at 6 sites: Hilliard, New Orleans and Edinburg among others. To minimise the burden of travel associated with participation in this trial, it is advised that participants select the location closest to them." - Anonymous Online Contributor

Unverified Answer

To what extent is this experiment being conducted with participants?

"Absolutely, the info on clinicaltrials.gov demonstrates that this trial has been actively enrolling participants since its launch on 18th January 2022 and was most recently updated on 22nd August of the same year. 300 patients are currently being sought from 6 different medical centres for participation in the study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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