Implantable Tibial Neuromodulation for Overactive Bladder

(TITAN 2 Trial)

No longer recruiting at 32 trial locations

Overseen By Laura Giusto

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedtronicNeuro

Disqualifiers: Stress incontinence, Prior tibial implant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tibial neuromodulation for individuals with overactive bladder, which leads to frequent and urgent bathroom visits. The researchers aim to determine if the Medtronic Tibial Neuromodulation (TNM) system is safe and effective. Suitable participants have experienced overactive bladder for at least six months and have not found success with other treatments. Participants must maintain a diary of their symptoms and be able to use the treatment system. As an unphased trial, this study provides a unique opportunity to explore a new treatment option that could enhance quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this device is safe for treating overactive bladder?

Research shows that the Medtronic system for tibial neuromodulation is generally safe for treating an overactive bladder. Studies have found that patients usually tolerate this treatment well and find it easy to undergo. Clinical trial data confirm its safety, with no major side effects reported. Additionally, studies on implantable versions of this technology have found them to be safe and effective. Overall, current research supports tibial neuromodulation as a safe option for managing urinary problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tibial Neuromodulation using the Medtronic TNM system because it offers a unique approach to treating overactive bladder. Unlike typical treatments like medications or sacral nerve stimulation, this method involves a minimally invasive device that targets the tibial nerve, which can help manage bladder function. This approach potentially reduces side effects and improves convenience, as it doesn't require surgery or frequent medication. The hope is that this treatment can provide effective relief with a better quality of life for patients dealing with overactive bladder.

What evidence suggests that this device is effective for overactive bladder?

In a previous study, about 60% of patients using percutaneous tibial nerve stimulation (PTNS) reported improved bladder symptoms. Another study found that implantable tibial neuromodulation is safe and effective for those with a strong, sudden need to urinate. A review of several studies has shown that both sacral and implantable tibial neuromodulation effectively treat an overactive bladder (OAB). Research also demonstrated that PTNS significantly improved symptoms and quality of life for both men and women with OAB. Overall, tibial neuromodulation, including the implantable tibial neuromodulation studied in this trial, appears to be a promising option for managing bladder issues. ^{2 3 6 7 8}

Who Is on the Research Team?

Mylene Champs

Principal Investigator

Medtronic

Are You a Good Fit for This Trial?

This trial is for adults who've had an overactive bladder (UUI) for at least 6 months and haven't seen improvement with standard treatments. Participants must be able to follow the study's procedures, like filling out diaries and operating the device. Pregnant women, those planning pregnancy, or individuals with recent pelvic surgeries or certain anatomical issues can't join.

Inclusion Criteria

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

Keep a record of your bathroom visits.

Willing and able to provide signed and dated informed consent

Exclusion Criteria

You have stress incontinence as your main urinary issue.

Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements

Concurrent participation in another clinical study that may add additional safety risks and/or confound study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tibial neuromodulation using the Medtronic TNM system

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tibial Neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system

Trial Overview The study is testing a new system called Medtronic Tibial Neuromodulation (TNM) to see if it's safe and works well for treating overactive bladder. It involves placing a device that stimulates nerves in the leg connected to bladder control.

Who Is Running the Clinical Trial?

MedtronicNeuro

Lead Sponsor

Trials

72

Recruited

20,900+

Geoff Martha

MedtronicNeuro

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Eric Peterson

MedtronicNeuro

Chief Medical Officer since 2020

MD from University of Miami

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5565382/

Effectiveness of percutaneous tibial nerve stimulation in the ... PTNS can indeed modulate the voiding and storage function of the bladder leading to an overall subjective improvement of symptoms in about 60% of the patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423001448

Rationale and design of an implant procedure and pivotal ... Data from the pivotal study support implantable tibial neuromodulation as a safe and effective treatment of urinary urge incontinence with a clinical success ...

3. link.springer.com link.springer.com/article/10.1007/s12325-024-03019-0

Sacral and Implantable Tibial Neuromodulation for the ... This meta-analysis found similar efficacy and safety of SNM and iTNM for the treatment of OAB and UUI, including UUI and OAB symptom response rates.

4. medtronic.com medtronic.com/en-us/healthcare-professionals/specialties/bladder-bowel-solutions/therapies-procedures/percutaneous-tibial-neuromodulation.html

Percutaneous Tibial Neuromodulation Therapies Clinical data: A safe option to restore bladder function†. PTNM delivered by the Medtronic NURO™ system, is a safe, minimally invasive, and effective OAB ...

5. frontiersin.org frontiersin.org/journals/urology/articles/10.3389/fruro.2024.1352701/full

Efficacy and sex-specific outcomes after six episodes of ... Results: PTNS treatment significantly improved the OAB symptoms and quality of life in men and women. PTNS increased the voided volume (p < 0.05) ...

6. medtronic.com medtronic.com/en-us/l/isw/percutaneous-tibial-neuromodulation-indications-safety-warnings.html

Percutaneous Tibial Neuromodulation - Indications, Safety ... Indication for Use: Medtronic NURO™ Percutaneous Tibial Neuromodulation is intended to treat patients with overactive bladder and associated symptoms of urinary ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05226286

Study Details | NCT05226286 | Evaluation of Implantable ... The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation ( ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12433157/

Effect of a novel implantable tibial nerve stimulation system ... The novel implantable TNS system demonstrated excellent safety, biocompatibility, and efficacy in reducing OAB symptoms in pigs. These findings support its ...