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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TENS
Sponsored by
Theranova, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring TENS

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TENS Treatment Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Urge Incontinence Episodes

Secondary Outcome Measures

Change in Micturitions Per Day
Mean number of urinary voids per day (taken over a 3-day period)
Change in Health-related Quality of Life (HRQL)
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.

Full Information

First Posted
June 22, 2018
Last Updated
April 30, 2021
Sponsor
Theranova, L.L.C.
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03595215
Brief Title
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Acronym
OAB Aim 2
Official Title
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theranova, L.L.C.
Collaborators
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
TENS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS Treatment Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
Transcutaneous electrical nerve stimulation
Primary Outcome Measure Information:
Title
Change in Urge Incontinence Episodes
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Micturitions Per Day
Description
Mean number of urinary voids per day (taken over a 3-day period)
Time Frame
Baseline and 8 weeks
Title
Change in Health-related Quality of Life (HRQL)
Description
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.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females 55-100 years old Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary) Have self-reported bladder symptoms of more than 3 months Are ambulatory and able to use the toilet independently 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 Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe) Able to provide informed consent Capable and willing to follow all study-related procedures Exclusion Criteria: Have primary complaint of stress urinary incontinence Have a pacemaker or implantable defibrillator Had botox injections in the bladder or pelvic floor muscles in the past 12 months Have a current urinary tract or vaginal infection Have an active implantable SNS device (InterStim & Bion) Have been diagnosed with peripheral neuropathy or nerve damage Currently pregnant Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Facility Information:
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

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Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home

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