A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

Not Applicable

Terminated

• Conditions: Urge Incontinence; Overactive Bladder
• Interventions: Device: Transcutaneous Electrical Nerve Stimulation

• Registration Number: NCT02922842
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-25
• Study Start: 2016-07
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shoulder	Transcutaneous Electrical Nerve Stimulation	Transcutaneous electrical stimulation will be placed on the shoulder.
Parasacral	Transcutaneous Electrical Nerve Stimulation	Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina.
Tibial Nerve	Transcutaneous Electrical Nerve Stimulation	Transcutaneous electrical stimulation will be placed on the posterior tibial nerve.

Primary Outcome Measures

Name	Time	Method
Number of incontinence episodes per day	6 weeks	Patients will self-report the number of incontinence episodes.

Secondary Outcome Measures

Name	Time	Method
Number of bladder voids per day	6 weeks	Patients will self-report the number of times they void their bladder.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States