A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
Primary Purpose
Urge Incontinence, Overactive Bladder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation
Sponsored by
About this trial
This is an interventional device feasibility trial for Urge Incontinence focused on measuring transcutaneous electrical nerve stimulation
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.
- 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.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Tibial Nerve
Parasacral
Shoulder
Arm Description
Transcutaneous electrical stimulation will be placed on the posterior tibial nerve.
Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina.
Transcutaneous electrical stimulation will be placed on the shoulder.
Outcomes
Primary Outcome Measures
Number of incontinence episodes per day
Patients will self-report the number of incontinence episodes.
Secondary Outcome Measures
Number of bladder voids per day
Patients will self-report the number of times they void their bladder.
Full Information
NCT ID
NCT02922842
First Posted
May 25, 2016
Last Updated
November 16, 2018
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT02922842
Brief Title
A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
Official Title
A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
underenrollment
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Incontinence, Overactive Bladder
Keywords
transcutaneous electrical nerve stimulation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tibial Nerve
Arm Type
Active Comparator
Arm Description
Transcutaneous electrical stimulation will be placed on the posterior tibial nerve.
Arm Title
Parasacral
Arm Type
Active Comparator
Arm Description
Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina.
Arm Title
Shoulder
Arm Type
Sham Comparator
Arm Description
Transcutaneous electrical stimulation will be placed on the shoulder.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Other Intervention Name(s)
TENS device
Primary Outcome Measure Information:
Title
Number of incontinence episodes per day
Description
Patients will self-report the number of incontinence episodes.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of bladder voids per day
Description
Patients will self-report the number of times they void their bladder.
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
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