Evaluation of the TheraNova Neuromodulation System to Provide Durable Relief of Overactive Bladder Symptoms

To evaluate the safety and durability of the TheraNova Neuromodulation System in overactive bladder (OAB) patients.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: TheraNova Neuromodulation Device

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Health
    • Stanford, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maintenance group; 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.	Device: TheraNova Neuromodulation Device; TENS device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 weeks

Collaborators and Investigators

• Sponsor: Theranova, L.L.C.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: CRD-10-1332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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