Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
Primary Purpose
Overactive Bladder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TheraNova Neuromodulation System
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
Women and men ≥18 years of age
- Individual has a diagnosis of OAB with urge urinary incontinence or mixed incontinence (urge and stress) with urge urinary incontinence being the most bothersome type of urinary incontinence for at least 6 months (self-reported)
- Individual has ≥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
- Individual has a mean frequency of urinary voiding events per day ≥10 times in one 24-hour day as recorded in the baseline 3-day voiding diary
- Individual is ambulatory and able to use the toilet independently
- Individual has not taken antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment
- Individual is able to provide informed consent
- Individual is capable and willing to follow all study-related procedures
Exclusion Criteria:
• Individual has stress urinary incontinence as the most bothersome type of urinary incontinence (self-report)
- Individual has an abnormal post-void residual urine volume (>150 cc at baseline)
- Male who has a clinically significant bladder outlet obstruction (assessed by uroflow, maximum flow rate <15 mL/s for a voided volume of at least 150 cc)
- Male who has been previously diagnosed with Benign Prostate Hyperplasia
- Male who has abnormal serum PSA (>2.5 ng/mL)
- Individual has abnormal serum creatinine levels (>1.2 mg/dL for women and >1.4 mg/dL for men)
- Individual has history of chronic kidney disease
- 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
- Female who is less than one-year post-partum and/or is breast-feeding
- Female with a clinically significant pelvic organ prolapse (≥ stage III on POP-Q evaluation)
- Individual has diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C ≥ 8.5)
- Individual has known polyuria
- Individual has an active urinary tract infection (UTI) at the time of enrollment
- Individual has recurrent UTI defined as ≥4 UTIs in the past 12 months
- 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 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 had previous treatment with sacral neuromodulation
- Individual has been treated with percutaneous tibial nerve stimulation or pelvic floor muscle stimulation
- Individual is currently using, or has used in the past 3 months, transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, legs, or feet
- 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 MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active
Sham
Arm Description
Outcomes
Primary Outcome Measures
The primary effectiveness endpoint is the percentage of subjects with at least a 50% reduction in frequency of UUI events from baseline to 12 weeks as measured in 3-day voiding diaries.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04758247
Brief Title
Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
Official Title
Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 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
5. Study Description
Brief Summary
To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
TheraNova Neuromodulation System
Intervention Description
The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.
Primary Outcome Measure Information:
Title
The primary effectiveness endpoint is the percentage of subjects with at least a 50% reduction in frequency of UUI events from baseline to 12 weeks as measured in 3-day voiding diaries.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women and men ≥18 years of age
Individual has a diagnosis of OAB with urge urinary incontinence or mixed incontinence (urge and stress) with urge urinary incontinence being the most bothersome type of urinary incontinence for at least 6 months (self-reported)
Individual has ≥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
Individual has a mean frequency of urinary voiding events per day ≥10 times in one 24-hour day as recorded in the baseline 3-day voiding diary
Individual is ambulatory and able to use the toilet independently
Individual has not taken antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment
Individual is able to provide informed consent
Individual is capable and willing to follow all study-related procedures
Exclusion Criteria:
• Individual has stress urinary incontinence as the most bothersome type of urinary incontinence (self-report)
Individual has an abnormal post-void residual urine volume (>150 cc at baseline)
Male who has a clinically significant bladder outlet obstruction (assessed by uroflow, maximum flow rate <15 mL/s for a voided volume of at least 150 cc)
Male who has been previously diagnosed with Benign Prostate Hyperplasia
Male who has abnormal serum PSA (>2.5 ng/mL)
Individual has abnormal serum creatinine levels (>1.2 mg/dL for women and >1.4 mg/dL for men)
Individual has history of chronic kidney disease
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
Female who is less than one-year post-partum and/or is breast-feeding
Female with a clinically significant pelvic organ prolapse (≥ stage III on POP-Q evaluation)
Individual has diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C ≥ 8.5)
Individual has known polyuria
Individual has an active urinary tract infection (UTI) at the time of enrollment
Individual has recurrent UTI defined as ≥4 UTIs in the past 12 months
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 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 had previous treatment with sacral neuromodulation
Individual has been treated with percutaneous tibial nerve stimulation or pelvic floor muscle stimulation
Individual is currently using, or has used in the past 3 months, transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, legs, or feet
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 Medicine
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
Learn more about this trial
Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
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