A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

University of Rochester1 site in 1 country15 target enrollmentJuly 2016

ConditionsUrge Incontinence Overactive Bladder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urge Incontinence
Sponsor: University of Rochester
Enrollment: 15
Locations: 1
Primary Endpoint: Number of incontinence episodes per day
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.

Registry

clinicaltrials.gov

Start Date

July 2016

End Date

May 1, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Rochester

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who are clinically diagnosed with urge incontinence, defined as urinary leakage associated with a sudden, strong desire to pass urine that is difficult to defer.
•Patients with urge predominant mixed incontinence.
•Patients will need to have answered at "Yes" to "leakage related to feeling urgency" on the UDI 6 questionnaire.
•Over 18 years of age.
•English speaking who are able to give informed consent to participate in the study.
•Patients who have four urinary incontinence episodes.

Exclusion Criteria

•Stress incontinence desiring surgical management.
•Previous treatment of refractory urge incontinence such as PTNS, SNS, or Intradetrusor onabotulinumtoxin A injections.
•Neurological conditions affecting continence such as multiple sclerosis, a history of spinal shock within the past year, or neurologic impairment requiring a wheelchair.
•Urethral diverticulum.
•Daily catheterization due to urinary retention.
•The use of anticholinergic medications for less than 6 weeks.
•Patients who have pacemakers in place.
•Patients with limited mobility requiring a wheelchair.
•Elevated PVR \> 200 cc
•Untreated urinary tract infection, defined as symptoms and a urine culture with greater than 100,000 cfu/ ml within the last 1 month prior to treatment.