Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms

February 27, 2024 updated by: Theranova, L.L.C.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Health
      • Stanford, California, United States, 94305
        • Stanford Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active
Device: TheraNova Neuromodulation System
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.
Sham Comparator: Sham
Device: TheraNova Neuromodulation System
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theranova, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRD-10-1330

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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