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Neuromodulation Device
Neuromodulation Therapy 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 trialtests the safety and effectiveness of a device to treat OAB in patients, looking at incontinence and adverse events.
Who is the study for?
This trial is for adults over 18 with overactive bladder (OAB) who experience at least four incontinence events due to urgency per day. Participants should not have taken certain OAB medications recently and must be able to perform daily activities independently. Exclusions include pregnancy, UTI, prostate or bladder cancer, severe obesity, significant urinary issues like retention or obstruction, metal implants in specific body areas, prior neuromodulation treatments, neuropathy conditions, investigational drug/device use within the last month among others.Check my eligibility
What is being tested?
The TheraNova Neuromodulation System's safety and effectiveness are being tested on patients with OAB symptoms. The study will compare the system's active treatment against a sham (placebo-like) treatment by measuring changes in urinary urge incontinence after 12 weeks using voiding diaries.See study design
What are the potential side effects?
While specific side effects aren't listed here, common risks may include device-related adverse events such as discomfort at the implant site or potential malfunction of the neuromodulation system which could affect bladder control.
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
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.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Group II: ShamPlacebo Group1 Intervention
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Who is running the clinical trial?
Theranova, L.L.C.Lead Sponsor
11 Previous Clinical Trials
457 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with prostate, urethral, or bladder cancer.You are extremely overweight, with a BMI of 40 or higher.You have already received treatment with sacral neuromodulation.You have a metal implant that is visible under the skin in certain areas of the body.You have received treatment involving nerve stimulation in the tibial area or muscle stimulation in the pelvic floor.You have stress urinary incontinence as the main type of urinary incontinence that bothers you.Your bladder does not empty completely after urinating.Men who have a problem with their bladder that makes it difficult to urinate.Men who have been diagnosed with benign prostate hyperplasia.Men with high PSA levels (>2.5 ng/mL) are not eligible.You have a medical condition that causes problems with urination.You have a serious nerve problem in your arms or legs.You have a condition called polyuria, which causes excessive urination.You have a urinary fistula, bladder stone, or interstitial cystitis.You have a medical device implanted in your body that uses electricity or stimulates nerves.You have used a device that sends electrical pulses to your pelvic region, back, legs, or feet in the past 3 months.You have experienced at least 4 instances of incontinence with strong urgency, and at least one of these instances happens every day, as noted in a 3-day record of your bathroom visits.You have had significant pelvic pain as the main health issue in the past year.You have a condition that affects your bladder, such as multiple sclerosis, Parkinson's disease, or a spinal cord injury.Adults who are 18 years old or older, regardless of gender.Your blood test shows high creatinine levels, which can be a sign of kidney problems.You have a history of long-term kidney problems.You have peripheral arterial disease.You have been diagnosed with overactive bladder (OAB) and experience frequent, sudden urges to urinate, leading to urinary accidents, and this has been bothering you for at least 6 months.You pee more than 10 times in a day, based on a 3-day record of your bathroom visits.Women with a severe pelvic organ prolapse.You have severe uncontrolled diabetes with complications affecting your nerves.You have had four or more urinary tract infections in the last year.You have received onabotulinumtoxinA treatment in the last 9 months.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Sham
Awards:
This trial has 0 awards, including: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.
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