Tibial Nerve Stimulation for Urinary Incontinence

Recruiting at 27 trial locations

Overseen By Samuel Lawindy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Coloplast A/S

Must not be taking: OAB medications, Anticoagulants

Disqualifiers: Stress incontinence, Chronic pain, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

208 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You will need to stop taking overactive bladder (OAB) medications for the duration of the study. However, you must maintain a stable dose of any other medications that affect bladder function for at least four weeks before starting the study.

What data supports the effectiveness of the treatment INTIBIA Non-Therapeutic, INTIBIA Therapeutic for urinary incontinence?

Research shows that tibial nerve stimulation, similar to INTIBIA treatments, has been effective in reducing symptoms of urge urinary incontinence and overactive bladder in various studies. This includes both percutaneous (through the skin) and transcutaneous (across the skin) methods, which have shown positive results in managing urinary symptoms. ^{1 2 3 4 5}

Is tibial nerve stimulation safe for humans?

Research shows that tibial nerve stimulation, including implantable devices, has been evaluated for safety in treating overactive bladder and urgency urinary incontinence. These studies generally support its safety in humans, with no major safety concerns reported. ^{5 6 7 8 9}

How is the treatment INTIBIA Therapeutic for urinary incontinence different from other treatments?

INTIBIA Therapeutic involves tibial nerve stimulation, which is a unique approach that uses electrical impulses to stimulate the tibial nerve near the ankle, helping to control bladder function. This method is different from traditional treatments like medications or surgery, as it is non-invasive and focuses on nerve modulation to reduce symptoms of urinary incontinence. ^{1 2 3 8 10}

Research Team

Catherine Matthews, MD

Principal Investigator

Wake Forest University

Eligibility Criteria

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.

Inclusion Criteria

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

I am willing and able to agree to participate in the study.

I have tried and not benefited from non-medical treatments for bladder control.

Exclusion Criteria

Have post-void residual urine volume >30% of total voided volume

You are allergic to numbing medicine or adhesive materials.

I have not had botulinum toxin therapy for urinary issues in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Treatment

All eligible subjects are implanted with the INTIBIA device and randomized to either therapeutic or non-therapeutic stimulation for the first 3 months.

3 months

Monthly visits for device programming and monitoring

Therapeutic Treatment

All subjects receive therapeutic stimulation after the initial 3 months.

21 months

Follow-up visits at Months 6, 12, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including voiding diaries and questionnaires.

24 months

Follow-up visits at Months 3, 6, 12, and 24

Device Retention or Removal

Participants are offered the option to keep the device or have it explanted at the end of the study.

Treatment Details

Interventions

• INTIBIA Non-Therapeutic
• INTIBIA Therapeutic

Trial Overview 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.

Participant Groups

Group I: INTIBIA Therapeutic Experimental Treatment 1 Intervention

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

Group II: INTIBIA Non-Therapeutic Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Coloplast A/S

Lead Sponsor

Trials

155

Recruited

14,800+

Founded

1957

Headquarters

Humlebæk, Denmark

Known For

Intimate Healthcare Solutions

Top Products

Ostomy bags, Continence products, Wound dressings

Kristian Villumsen

Coloplast A/S

Chief Executive Officer since 2018

Master's degree in Political Science from Aarhus University

Preeti Jain

Coloplast A/S

Chief Medical Officer since 2023

MD from University of Copenhagen

Findings from Research

The eCoin® neuromodulation device, implanted in 46 participants with refractory urgency urinary incontinence, demonstrated a significant 71% reduction in daily episodes of incontinence after 3 months, indicating its efficacy in treating this condition.

The device was found to be safe, with only one serious adverse event related to wound care, which was resolved with treatment, suggesting minimal safety concerns associated with its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence. MacDiarmid, S., Staskin, DR., Lucente, V., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Posterior tibial nerve stimulation in the treatment of urge incontinence. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

[Percutaneous tibial nerve stimulation in urge urinary incontinence: A prospective study]. [2021]

3. Spain pubmed.ncbi.nlm.nih.gov

Transcutaneous stimulation of the posterior tibial nerve for treating refractory urge incontinence of idiopathic and neurogenic origin. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of transcutaneous tibial nerve stimulation at two different thresholds for overactive bladder symptoms in older women: a randomized controlled clinical trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Development of an implant technique and early experience using a novel implantable pulse generator with a quadripolar electrode array at the tibial nerve for refractory overactive bladder. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Neuromodulative treatment with percutaneous tibial nerve stimulation for intractable detrusor instability: outcomes following a shortened 6-week protocol. [2010]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Peripheral afferent nerve stimulation for treatment of lower urinary tract irritative symptoms. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and effectiveness of percutaneous tibial nerve stimulation in the treatment of pelvic organ disorders: a systematic review. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Tibial Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review. [2018]