A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

University of Rochester

Status: Terminated

Conditions: Overactive Bladder; Urge Incontinence

Treatments: Device: Transcutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02922842

RSRB00060370

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 3 patient groups

Tibial Nerve

Active Comparator group

Description:

Transcutaneous electrical stimulation will be placed on the posterior tibial nerve.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

Parasacral

Active Comparator group

Description:

Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

Shoulder

Sham Comparator group

Description:

Transcutaneous electrical stimulation will be placed on the shoulder.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation