Neuspera Sacral Neuromodulation for Urge Incontinence

Overseen By Shital Patel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neuspera Medical, Inc.

Must not be taking: OAB medications, Botulinum toxins

Disqualifiers: Diabetes, Neuropathy, Neurogenic bladder, others

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with urinary urge incontinence who haven't found success with other treatments. The focus is on the Neuspera Sacral Neuromodulation System, a small device that stimulates nerves to help control the bladder. Participants will use the device for 30 minutes daily to determine if it reduces their symptoms. It suits those who have experienced urinary urge incontinence for over six months and haven't responded well to medications. As an unphased trial, this study offers a unique opportunity to explore a novel treatment option that could improve quality of life.

Will I have to stop taking my current medications?

You may need to stop taking certain overactive bladder (OAB) medications for a period before and during the study, unless you and your doctor decide it's best to continue them throughout the study. The specific time without taking these medications will depend on the type of medication you are using.

What prior data suggests that the Neuspera Sacral Neuromodulation System is safe for treating urinary urge incontinence?

Research has shown that the Neuspera Sacral Neuromodulation (SNM) System is safe for treating urinary urge incontinence. Studies have found that it reduces symptoms in patients who haven't had success with other treatments. The FDA has approved this system for this condition, indicating it meets safety standards. Ongoing studies are evaluating its long-term safety, and so far, it appears well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for urge incontinence involve medications or traditional sacral nerve stimulation, which can require more invasive procedures and longer recovery times. The Neuspera Sacral Neuromodulation (SNM) System is unique because it uses an implantable device that can deliver nerve stimulation with a shorter duration, potentially offering quicker relief with less invasiveness. Researchers are excited about this treatment because it represents a less invasive option with the potential for faster symptom improvement, making it a promising alternative for those who haven't found success with existing therapies.

What evidence suggests that the Neuspera Sacral Neuromodulation System is effective for urinary urge incontinence?

Research has shown that the Neuspera Sacral Neuromodulation System, which trial participants will receive, effectively treats urinary urge incontinence. One study found the device performed as well as traditional treatments, with 42% of patients becoming completely dry and 82% experiencing a reduction in symptoms by half. Another report indicated that 85% to 95% of users had significant improvements. The system targets sacral nerves, which help control the bladder, to manage incontinence symptoms effectively. These findings suggest that Neuspera's method can provide meaningful relief for those dealing with urge incontinence. ^{2 5 6 7 8}

Who Is on the Research Team?

Jessica Reub, MD

Principal Investigator

Southern Urogynecology

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with urge incontinence or overactive bladder, who haven't had success with standard treatments. Participants must have tried and not responded well to certain medications, be willing to stop taking these meds during the study, and have shown a positive response to initial stimulation therapy.

Inclusion Criteria

I am 22 years old or older.

I have been diagnosed with urge urinary incontinence for 6 months or more.

I can't use certain bladder medications due to side effects or they didn't work for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial Stimulation

Subjects undergo a trial stimulation period to assess initial response to the Neuspera System

1 month

Permanent Implant

Subjects receive a permanent implant of the Neuspera Sacral Neuromodulation System

6 months

Regular follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Neuspera Sacral Neuromodulation (SNM) System

Trial Overview

The study tests the Neuspera System's effectiveness in providing daily 30-minute therapeutic stimulation as a treatment for urinary urge incontinence. It's a single-arm study focusing on those who didn't benefit from more common treatments.

How Is the Trial Designed?

Group I: Neuspera Implantable Sacral Nerve Stimulation System Experimental Treatment 1 Intervention

Implantation of the stimulator to assess effectiveness with shorter duration of stimulation

Who Is Running the Clinical Trial?

Neuspera Medical, Inc.

Lead Sponsor

Trials

2

Recruited

250+

Citations

1.

neuspera.com

neuspera.com/neuspera-medical-announces-landmark-six-month-clinical-trial-results-for-the-first-battery-free-percutaneous-sacral-neuromodulation-psnm-system-for-urgency-urinary-incontinence-management/

Neuspera Medical Announces Landmark Six-Month ...

“These results demonstrate that Neuspera's pSNM technology provides similar effectiveness to traditional SNM devices while offering an ...

2.

neuspera.com

neuspera.com/neuspera-medical-receives-fda-approval-for-first-integrated-sacral-neuromodulation-isnm-system-for-urinary-urge-incontinence/

Neuspera Medical Receives FDA Approval for First ...

Six-month pivotal trial data showed the Neuspera iSNM device delivers efficacy comparable to established SNM therapies, while eliminating the ...

3.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf24/P240031B.pdf

summary of safety and effectiveness data (ssed)

The Neuspera Sacral Neuromodulation System (“Neuspera SNM System”) is indicated for the treatment of the symptoms of urinary urge incontinence (UUI) in ...

4.

auajournals.org

auajournals.org/doi/10.1097/JU.0000000000002110.01

PRELIMINARY OUTCOMES OF THE SANS-UUI STUDY

Using the Neuspera ultra-miniaturized SNM system 2 hrs / day is safe and effective with 85% and 95% of subjects with clinically and ...

5.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/neuspera-neuromodulation-device-hits-gold-standard-in-incontinence-trial/

Neuspera neuromodulation device hits “gold standard” in ...

Results from the Phase II pivotal incontinence trial saw 42% of patients being declared completely dry, and 82% seeing a reduction by half.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf24/P240031C.pdf

Neuspera Sacral Neuromodulation System

The study showed that the Neuspera SNM System was safe and worked to help reduce symptoms of urinary urge incontinence (UUI) in patients. Researchers looked at ...

7.

neuspera.com

neuspera.com/

Neuspera Medical | Implantable Medical Device Technology ...

At Neuspera, we understand your challenge with Urinary Urge Incontinence (UUI), a symptom of Overactive Bladder (OAB) affecting 1 in 5 women in the U.S. Our ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04232696

Neuspera's Implantable Sacral Nerve Stimulation System ...

Objective of Phase II: To assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary ...