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A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

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ClinicalTrials.gov Identifier: NCT02922842
Recruitment Status : Terminated (underenrollment)
First Posted : October 4, 2016
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
University of Rochester

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.

Condition or disease Intervention/treatment Phase
Urge Incontinence Overactive Bladder Device: Transcutaneous Electrical Nerve Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Device Feasibility
Official Title: A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
Study Start Date : July 2016
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tibial Nerve
Transcutaneous electrical stimulation will be placed on the posterior tibial nerve.
Device: Transcutaneous Electrical Nerve Stimulation
Other Name: 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 Name: TENS device

Sham Comparator: Shoulder
Transcutaneous electrical stimulation will be placed on the shoulder.
Device: Transcutaneous Electrical Nerve Stimulation
Other Name: TENS device




Primary Outcome Measures :
  1. Number of incontinence episodes per day [ Time Frame: 6 weeks ]
    Patients will self-report the number of incontinence episodes.


Secondary Outcome Measures :
  1. Number of bladder voids per day [ Time Frame: 6 weeks ]
    Patients will self-report the number of times they void their bladder.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922842


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester

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Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT02922842     History of Changes
Other Study ID Numbers: RSRB00060370
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by University of Rochester:
transcutaneous electrical nerve stimulation
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Incontinence
Urination Disorders