What side effects are associated with this type of intervention?

Common treatments for Lower Urinary Tract Symptoms (LUTS) similar to the implantable tibial nerve stimulator include transcutaneous electrical nerve stimulation (TENS) and sacral neuromodulation. Known side effects of these treatments can include local discomfort or pain at the site of stimulation, skin irritation, and, in rare cases, infection at the implantation site. Additionally, some patients may experience temporary changes in bladder or bowel function. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

FDA-approved treatments for Lower Urinary Tract Symptoms (LUTS) include various neuromodulation techniques such as sacral neuromodulation and percutaneous tibial nerve stimulation (PTNS). Sacral neuromodulation, using devices like InterStim, has been approved for conditions like overactive bladder and urinary retention. PTNS, which involves electrical stimulation of the tibial nerve, has shown efficacy in reducing symptoms of overactive bladder. Additionally, medications such as antimuscarinics (e.g., oxybutynin, tolterodine) and beta-3 adrenergic agonists (e.g., mirabegron) are commonly used to manage LUTS. These treatments aim to modulate bladder control and improve urinary symptoms.

What other types of research exist?

Promising, novel alternatives to Implantable Tibial Nerve Stimulator for LUTS patients include: 1) Intravesical Botulinum Toxin A injections, which have shown efficacy in reducing bladder pain and improving bladder function. 2) Spinal Cord Stimulation, which has been effective in managing chronic pain and may offer benefits for bladder control. 3) Myofascial Physical Therapy, which targets pelvic floor dysfunction and has shown positive outcomes in patients with interstitial cystitis/bladder pain syndrome. 4) Intravesical Glycosaminoglycan Substitution Therapy, which helps restore the bladder lining and reduce symptoms. These alternatives are supported by clinical trials and studies demonstrating their potential benefits for LUTS patients.

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Implantable Device

Tibial Nerve Stimulation for Urinary Incontinence

N/A

Recruiting

Led By Catherine Matthews, MD

Research Sponsored by Coloplast A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptoms of overactive bladder with urgency urinary incontinence (UUI) demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, and at least one leaking episode each 24-hour period

Ambulatory and able to use the toilet independently and without difficulty

Must not have

Current symptomatic urinary tract infection (UTI), urethritis, or more than three (3) UTIs in past year

Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, and 12 months

Awards & highlights

Summary

This trial is testing a small device that sends electrical signals to a nerve in the leg to help people who have sudden, strong urges to urinate. The study focuses on patients who struggle with urgency urinary incontinence and aims to see if this new approach can better manage their condition. Tibial-nerve stimulation has shown promising results in previous studies.

Who is the study for?

This trial is for adults aged 22-80 with a history of urgency urinary incontinence (UUI) who've tried other therapies without success. Participants must not be pregnant, planning pregnancy, or have certain health conditions like end-stage renal failure or neurological disorders that affect bladder function.

What is being tested?

The INTIBIA study tests an implantable tibial nerve stimulator's safety and effectiveness for UUI. It's a double-blind study, meaning neither the researchers nor participants know who gets the therapeutic device versus a non-therapeutic version.

What are the potential side effects?

Potential side effects may include local reactions at the implant site such as pain or infection, allergic responses to materials in the device, and possible interference with lower leg MRI procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have overactive bladder with leaks due to urgency, noted daily for 3 days.

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I can walk and use the bathroom by myself without help.

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I have been diagnosed with urge incontinence for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have a UTI or have had more than 3 UTIs in the last year.

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I have a blockage in my urinary tract.

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I have an ongoing or chronic infection.

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I have diabetes with nerve damage or my diabetes is not well-controlled.

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I do not have any neurological conditions affecting my bladder or leg nerves.

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My kidney function is very low or I am on dialysis.

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I have tried nerve stimulation therapy for urinary issues.

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I need an MRI scan of my lower leg.

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I do not have infections, swelling, or inflammation in my legs.

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I do not have body structures that could make placing a medical device risky.

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I have been diagnosed with stress or mixed urinary incontinence.

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I have problems with my urinary system not related to cancer.

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My pelvic organs have dropped to or past the vaginal opening.

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I have been diagnosed with interstitial cystitis or bladder pain syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Daily Voids

Dry

EQ-5D-5L Questionnaire

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: INTIBIA TherapeuticExperimental Treatment1 Intervention

Implanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study.

Group II: INTIBIA Non-TherapeuticExperimental Treatment1 Intervention

Implanted with INTIBIA device and programmed to non-therapeutic stimulation for the first 3 months, then to therapeutic stimulation for the duration of the study.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Electrical stimulation therapies, such as the Implantable Tibial Nerve Stimulator, work by modulating neural pathways that control bladder function. By stimulating the tibial nerve, these devices can inhibit overactive bladder contractions and improve bladder control. This is particularly relevant for LUTS patients as it offers a minimally invasive option that can reduce symptoms like urgency, frequency, and incontinence. Other common treatments include pharmacologic agents like antimuscarinics and beta-3 agonists, which relax bladder muscles and increase storage capacity, and behavioral therapies that focus on bladder training and pelvic floor muscle exercises. These treatments aim to improve quality of life by reducing the discomfort and inconvenience associated with LUTS.

Tibial nerve stimulation to inhibit the micturition reflex by an implantable wireless driver microstimulator in cats.