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Neuromodulation Device
Neuromodulation Device for Overactive Bladder
N/A
Waitlist Available
Research Sponsored by Theranova, L.L.C.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trialwill test a new device to treat OAB and check its safety and effectiveness.
Who is the study for?
This trial is for people who've completed a prior study on the TheraNova device for Overactive Bladder (OAB) and have frequent incontinence. They must be able to use the toilet without help, give informed consent, not take certain bladder medications recently, and can't be pregnant or planning pregnancy during the study.Check my eligibility
What is being tested?
The TheraNova Neuromodulation System is being tested for its safety and long-term effectiveness in managing OAB symptoms. Participants are those who previously responded well to this treatment in an earlier phase of research.See study design
What are the potential side effects?
While specific side effects aren't listed here, neuromodulation devices like TheraNova may cause discomfort at the implant site, changes in bowel movements or urination patterns, skin irritation, or nerve injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
UUIs
Trial Design
1Treatment groups
Experimental Treatment
Group I: Maintenance groupExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TheraNova Neuromodulation Device
2022
N/A
~10
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Who is running the clinical trial?
Theranova, L.L.C.Lead Sponsor
11 Previous Clinical Trials
466 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have peripheral arterial disease.You have a urinary fistula, bladder stone, or interstitial cystitis.You have had four or more urinary tract infections in the past year.You have received onabotulinumtoxinA treatment in the last 9 months.You have a serious nerve problem in your arms or legs.You have had frequent and severe pelvic pain in the past year.You have a condition that affects your bladder function, such as multiple sclerosis, Parkinson's disease, or spinal cord injury.You have been diagnosed with prostate, urethral, or bladder cancer.You are extremely overweight with a BMI of 40 or higher.You have a medical condition that causes narrowing in the urethra or bladder neck.You have a metal implant that is close to the skin on the bottom of your foot or the front of your mid-thigh.You have a medical device implanted in your body that uses electricity or stimulates nerves.You have received treatment involving stimulation of the tibial nerve or pelvic floor muscles.You experience at least 4 episodes of incontinence with strong urgency, and have at least one such episode per day, as recorded in the 3-day diary before the study starts.You have not taken certain medications for at least 2 weeks before joining the study.You are not taking water pills, or if you are, you have been taking the same dose for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Maintenance group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patient volunteers being accepted for this experiment presently?
"According to information on clinicaltrials.gov, this medical trial is actively looking for participants that meet the inclusion criteria. The research was first made publicly available on February 20th 2022 and underwent a recent update in December 23rd of the same year."
Answered by AI
How many participants are actively involved in this research project?
"Affirmative. Clinicaltrials.gov reveals that this investigation is currently in search of participants, which was initially published on February 20th 2022 and has been recently updated on December 23rd 2022. This study requires a total of 50 individuals to be enlisted from 2 distinct medical facilities."
Answered by AI
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