A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

November 16, 2018 updated by: University of Rochester
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.
  • Female
  • 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.
  • Uncorrected Stage 3 prolapse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tibial Nerve
Transcutaneous electrical stimulation will be placed on the posterior tibial nerve.
Device: Transcutaneous Electrical Nerve Stimulation
Other Names:
  • TENS device
Active Comparator: Parasacral
Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina.
Device: Transcutaneous Electrical Nerve Stimulation
Other Names:
  • TENS device
Sham Comparator: Shoulder
Transcutaneous electrical stimulation will be placed on the shoulder.
Device: Transcutaneous Electrical Nerve Stimulation
Other Names:
  • TENS device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of incontinence episodes per day
Time Frame: 6 weeks
Patients will self-report the number of incontinence episodes.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of bladder voids per day
Time Frame: 6 weeks
Patients will self-report the number of times they void their bladder.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB00060370

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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