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Neuromodulation System

StimRouter Treatment for Overactive Bladder

N/A
Waitlist Available
Led By Howard Goldman, MD
Research Sponsored by Bioness Inc
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 baseline through month 6
Awards & highlights

Study Summary

Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial

Eligible Conditions
  • Overactive Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1) Patient Voiding Diary
Adverse Events reported cumulatively throughout study
Secondary outcome measures
Seven-Day Patient Voiding Diary

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: StimRouter TreatmentExperimental Treatment1 Intervention
The Treatment group will receive therapeutic level StimRouter electrical stimulation. At the end of the Month 3 visit the Treatment group will continue to receive therapeutic level StimRouter electrical stimulation for an additional 3 months.
Group II: StimRouter ControlPlacebo Group1 Intervention
The Control group will receive sham (sub-therapeutic level only) StimRouter stimulation. At the end of the Month 3 visit the Control group will be allowed to receive therapeutic level StimRouter electrical stimulation for 3 months.

Find a Location

Who is running the clinical trial?

Bioness IncLead Sponsor
8 Previous Clinical Trials
557 Total Patients Enrolled
Keith McBrideStudy ChairBioness Inc
2 Previous Clinical Trials
179 Total Patients Enrolled
Howard Goldman, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial
2017. "Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02873312.
All > Overactive Bladder
~22 spots leftby Apr 2025
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