Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595215
Recruitment Status : Completed
First Posted : July 23, 2018
Results First Posted : January 3, 2020
Last Update Posted : May 21, 2021
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Theranova, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Device: TENS Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : July 10, 2019
Actual Study Completion Date : September 17, 2019

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




Primary Outcome Measures :
  1. Change in Urge Incontinence Episodes [ Time Frame: Baseline and 8 weeks ]

Secondary Outcome Measures :
  1. Change in Micturitions Per Day [ Time Frame: Baseline and 8 weeks ]
    Mean number of urinary voids per day (taken over a 3-day period)

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595215


Locations
Layout table for location information
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Theranova, L.L.C.
Stanford University
  Study Documents (Full-Text)

Documents provided by Theranova, L.L.C.:
Layout table for additonal information
Responsible Party: Theranova, L.L.C.
ClinicalTrials.gov Identifier: NCT03595215    
Other Study ID Numbers: CRD-12-1076
First Posted: July 23, 2018    Key Record Dates
Results First Posted: January 3, 2020
Last Update Posted: May 21, 2021
Last Verified: April 2021

Layout table for additional information
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
Keywords provided by Theranova, L.L.C.:
TENS
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations