A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
| Status: | Terminated |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/22/2018 |
| Start Date: | July 2016 |
| End Date: | May 1, 2018 |
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.
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.
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.
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