Palo Alto, California 94304

  • Overactive Bladder

Purpose:

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.


Criteria:

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 is Available At:


Original ID:

CRD-12-1076


NCT ID:

NCT03595215


Secondary ID:


Study Acronym:

OAB Aim 2


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

55 Years


Maximum Age:

100 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Theranova, L.L.C.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Study Dates

Start Date:September 10, 2018
Completion Date:September 17, 2019
Completion Type:Actual
Primary Completion Date:July 10, 2019
Primary Completion Type:Actual
Verification Date:April 2021
Last Changed Date:April 30, 2021
First Received Date:June 22, 2018
First Results Date:November 13, 2019

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in Health-related Quality of Life (HRQL)
Time Frame:Baseline and 8 weeks
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Change in Micturitions Per Day
Time Frame:Baseline and 8 weeks
Safety Issues:False
Description:Mean number of urinary voids per day (taken over a 3-day period)
Outcome Type:Primary Outcome
Measure:Change in Urge Incontinence Episodes
Time Frame:Baseline and 8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:TENS
Description:Transcutaneous electrical nerve stimulation
Arm Name:TENS Treatment Arm

Study Arms

Study Arm Type:Experimental
Arm Name:TENS Treatment 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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Theranova, L.L.C.
Agency Class:Other
Agency Type:Collaborator
Agency Name:Stanford University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 26, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.