← Back to Search

Electrical Stimulation

PTNS Arm for Overactive Bladder

N/A
Waitlist Available
Led By Mary E McVearry, DPT, WCS
Research Sponsored by Walter Reed National Military Medical Center
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 2 years
Awards & highlights

Study Summary

The purpose of this study is to determine whether transcutaneous sacral nerve stimulation (TENS SNS) versus percutaneous tibial nerve stimulation (PTNS) is a more effective therapeutic option for subjects with idiopathic overactive bladder (OAB) who have failed conventional therapy. Our primary hypothesis is that TENS therapy is a more effective treatment option due to ease of use and improved subject compliance with this form of therapy.

Eligible Conditions
  • Overactive Bladder
  • Urge Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Acoustic Stimulation

Trial Design

2Treatment groups
Active Control
Group I: PTNS ArmActive Control1 Intervention
Subjects randomized to the PTNS arm will undergo PTNS treatment once weekly for 30 minutes for 12 weeks total. If at 12 weeks they are considered to have a positive response to therapy, they will continue maintenance therapy in a tapered fashion: subjects will come in every 2 weeks for the next 8 weeks for 30 minute treatments (4 visits total), then every 3-4 weeks for 30 minute treatments for the remaining 32 weeks of the year (8-10 visits).
Group II: TENS ArmActive Control1 Intervention
Subjects randomized to the TENS arm of the study will begin therapy after their baseline evaluation is complete. They will be issued a home TENS device (EMPI TENS Select) and will administer self-treatment daily for 2 hours per day (1 hour in the morning and 1 hour in the evening) for a total of 12 weeks. If they are considered to have a positive response with TENS treatment, subjects will continue by weaning use over a three-month time period. They will begin with 3 x per week for 1 month, then 2 x per week for 1 month, then 1 x per week for 1 month, all at 2 hours per day.

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor
137 Previous Clinical Trials
34,383 Total Patients Enrolled
International Urogynecological Association (Grant)UNKNOWN
Section on Women's Health (Grant)UNKNOWN

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
Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments
Shannon Lamb 2013. "Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01940367.
All > Overactive Bladder
~10 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top