Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home (OAB Aim 2)

April 30, 2021 updated by: Theranova, L.L.C.
This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Females
  2. 55-100 years old
  3. Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary)
  4. Have self-reported bladder symptoms of more than 3 months
  5. Are ambulatory and able to use the toilet independently
  6. Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months
  7. Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe)
  8. Able to provide informed consent
  9. Capable and willing to follow all study-related procedures

Exclusion Criteria:

  1. Have primary complaint of stress urinary incontinence
  2. Have a pacemaker or implantable defibrillator
  3. Had botox injections in the bladder or pelvic floor muscles in the past 12 months
  4. Have a current urinary tract or vaginal infection
  5. Have an active implantable SNS device (InterStim & Bion)
  6. Have been diagnosed with peripheral neuropathy or nerve damage
  7. Currently pregnant
  8. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS Treatment Arm
This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.
Device: TENS
Transcutaneous electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Urge Incontinence Episodes
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Micturitions Per Day
Time Frame: Baseline and 8 weeks
Mean number of urinary voids per day (taken over a 3-day period)
Baseline and 8 weeks
Change in Health-related Quality of Life (HRQL)
Time Frame: Baseline and 8 weeks
Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theranova, L.L.C.

Collaborators

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

July 10, 2019

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

June 22, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD-12-1076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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