A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02922842
• Other study ID #: RSRB00060370
• Status: Terminated
• Phase: N/A
• Start date: July 2016
• Est. completion date: May 1, 2018

Study information

• Verified date: November 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urge Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence, Urge

Intervention

Device:
• Transcutaneous Electrical Nerve Stimulation

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incontinence episodes per day	Patients will self-report the number of incontinence episodes.	6 weeks
Secondary	Number of bladder voids per day	Patients will self-report the number of times they void their bladder.	6 weeks