Evaluation of the TheraNova Neuromodulation System to Provide Durable Relief of Overactive Bladder Symptoms
Primary Purpose
Overactive Bladder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TheraNova Neuromodulation Device
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
Individual completed the clinical study "Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms" (Protocol Number CRD-10-1330-01) as a subject in the Active Treatment group
- Individual has at least ≥4 incontinence events with associated moderate or severe urgency (UUI events), with at least one UUI event per day, as recorded in the baseline 3-day voiding diary at week 0 of the clinical study "Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms" (Protocol Number CRD-10- 1330-01)
- Individual is ambulatory and able to use the toilet independently
- Individual has not taken antimuscarinics, anticholinergics, beta-3 agonists, alpha blockers, 5-alpha reductase inhibitors, vasopressin analogues, tricyclic antidepressants, or phenazopyridine for at least 2 weeks prior to enrollment
- Individual is not taking diuretics or has been on a steady dose of diuretics for at least 3 months
- Individual is able to provide informed consent
- Individual is capable and willing to follow all study-related procedures
Exclusion Criteria:
Individual has recurrent UTI defined as ≥4 UTIs in the past 12 months
- Female of childbearing age (≤50 years old) who is pregnant as confirmed by urine pregnancy test, or who plans to become pregnant during the study period
- Individual has peripheral arterial disease
- Individual has the presence of a urinary fistula, bladder stone, or interstitial cystitis
- Individual has a diagnosis of prostate, urethral, or bladder cancer
- Individual has morbid obesity (BMI ≥ 40)
- Individual has clinically significant urethral stricture disease or bladder neck contracture
- Individual has a metallic implant that is exposed above the bone surface (e.g. a bone fracture fixation plate, but not an embedded bone screw) and is located under the skin on the bottom of the foot for either foot or under the skin on the anterior aspect of the mid-thigh for either leg.
- Individual has an implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
- Individual has been treated with percutaneous tibial nerve stimulation or pelvic floor muscle stimulation
- Individual has been treated with onabotulinumtoxinA in the past 9 months
- Individual has a clinically significant peripheral neuropathy
- Individual has a history of pelvic pain as primary diagnosis in the past 12 months (VAS score of >4 (scale of 0 to 10)) Individual has neurogenic bladder (i.e. Multiple Sclerosis, Parkinson's, Spinal Cord Injury)
- Individual has used an investigational drug, biologic, or medical device in the past 4 weeks
- Individual is deemed unsuitable for enrollment in the study by the investigator based on the subject's history or physical examination
Sites / Locations
- UC Davis HealthRecruiting
- Stanford University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Maintenance group
Arm Description
Subjects that completed the clinical study "Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms" that were in the active treatment group will be offered to extend treatment for 3 months.
Outcomes
Primary Outcome Measures
UUIs
change in the mean number of urge urinary incontinence (UUI) episodes per day from week 12 to week 24 (this study starts at 12 weeks)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05162833
Brief Title
Evaluation of the TheraNova Neuromodulation System to Provide Durable Relief of Overactive Bladder Symptoms
Official Title
Evaluation of the TheraNova Neuromodulation System to Provide Durable Relief of Overactive Bladder Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theranova, L.L.C.
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and durability of the TheraNova Neuromodulation System in overactive bladder (OAB) patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maintenance group
Arm Type
Experimental
Arm Description
Subjects that completed the clinical study "Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms" that were in the active treatment group will be offered to extend treatment for 3 months.
Intervention Type
Device
Intervention Name(s)
TheraNova Neuromodulation Device
Intervention Description
TENS device
Primary Outcome Measure Information:
Title
UUIs
Description
change in the mean number of urge urinary incontinence (UUI) episodes per day from week 12 to week 24 (this study starts at 12 weeks)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individual completed the clinical study "Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms" (Protocol Number CRD-10-1330-01) as a subject in the Active Treatment group
Individual has at least ≥4 incontinence events with associated moderate or severe urgency (UUI events), with at least one UUI event per day, as recorded in the baseline 3-day voiding diary at week 0 of the clinical study "Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms" (Protocol Number CRD-10- 1330-01)
Individual is ambulatory and able to use the toilet independently
Individual has not taken antimuscarinics, anticholinergics, beta-3 agonists, alpha blockers, 5-alpha reductase inhibitors, vasopressin analogues, tricyclic antidepressants, or phenazopyridine for at least 2 weeks prior to enrollment
Individual is not taking diuretics or has been on a steady dose of diuretics for at least 3 months
Individual is able to provide informed consent
Individual is capable and willing to follow all study-related procedures
Exclusion Criteria:
Individual has recurrent UTI defined as ≥4 UTIs in the past 12 months
Female of childbearing age (≤50 years old) who is pregnant as confirmed by urine pregnancy test, or who plans to become pregnant during the study period
Individual has peripheral arterial disease
Individual has the presence of a urinary fistula, bladder stone, or interstitial cystitis
Individual has a diagnosis of prostate, urethral, or bladder cancer
Individual has morbid obesity (BMI ≥ 40)
Individual has clinically significant urethral stricture disease or bladder neck contracture
Individual has a metallic implant that is exposed above the bone surface (e.g. a bone fracture fixation plate, but not an embedded bone screw) and is located under the skin on the bottom of the foot for either foot or under the skin on the anterior aspect of the mid-thigh for either leg.
Individual has an implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
Individual has been treated with percutaneous tibial nerve stimulation or pelvic floor muscle stimulation
Individual has been treated with onabotulinumtoxinA in the past 9 months
Individual has a clinically significant peripheral neuropathy
Individual has a history of pelvic pain as primary diagnosis in the past 12 months (VAS score of >4 (scale of 0 to 10)) Individual has neurogenic bladder (i.e. Multiple Sclerosis, Parkinson's, Spinal Cord Injury)
Individual has used an investigational drug, biologic, or medical device in the past 4 weeks
Individual is deemed unsuitable for enrollment in the study by the investigator based on the subject's history or physical examination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director of Clinical Engineering
Phone
4159268616
Email
clinicalstudy@theranova.com
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Overstreet-Benoit
Email
cboverstreet@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Elaine Waetjen, MD
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Batham
Email
kbatham@stanford.edu
First Name & Middle Initial & Last Name & Degree
Eric Sokol, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the TheraNova Neuromodulation System to Provide Durable Relief of Overactive Bladder Symptoms
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