Overactive Bladder, Urge Incontinence
Conditions
Keywords
transcutaneous electrical nerve stimulation
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.
Interventions
DEVICETranscutaneous Electrical Nerve Stimulation
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of incontinence episodes per day | 6 weeks | Patients will self-report the number of incontinence episodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of bladder voids per day | 6 weeks | Patients will self-report the number of times they void their bladder. |
Countries
United States
Outcome results
None listed