A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

Stopped early · Not applicable

Conditions studied: Urge Incontinence, Overactive Bladder

In brief

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.

Key facts

Study ID

NCT02922842

Run by

University of Rochester

People needed

15

Starts

2016-07-01

Expected to finish

2018-05-01

Last updated by the study team

2018-11-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.