Neuspera Sacral Neuromodulation for Overactive Bladder
(NSM-005 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the long-term safety and effectiveness of the Neuspera Sacral Neuromodulation System, a treatment for overactive bladder. Overactive bladder leads to frequent and urgent bathroom trips, disrupting daily life. This study involves individuals who participated in earlier phases of the Neuspera study. Participants will receive follow-up assessments to evaluate the treatment's long-term effectiveness and safety. As an unphased trial, this study provides a unique opportunity to contribute to ongoing research and potentially enhance the quality of life for others with overactive bladder.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the Neuspera Sacral Neuromodulation System is safe?
Research has shown that the Neuspera Sacral Neuromodulation System is generally safe. In earlier studies, participants with overactive bladder (a condition characterized by a sudden urge to urinate) experienced symptom improvement with just two hours of daily therapy.
Studies have monitored the system for up to 72 months to ensure its continued safety and effectiveness. Although specific side effects are not detailed in the sources, the device's FDA approval suggests it is safe for treating urinary urge incontinence (a sudden, strong need to urinate).
Overall, available data indicate that the treatment is well-tolerated. However, as with any medical device, some risks may exist, so consulting a healthcare provider before joining a trial is important.12345Why are researchers excited about this trial?
Unlike the standard treatments for overactive bladder, which often involve medications or traditional surgical interventions, the Neuspera Sacral Neuromodulation System offers a unique approach by using a tiny, implantable device to stimulate the sacral nerve. This system stands out because it provides long-term relief without the need for major surgery or daily medication, potentially reducing side effects and improving patient comfort. Researchers are excited about this treatment because it could offer a more convenient and less invasive option for managing overactive bladder symptoms, enhancing the quality of life for many patients.
What evidence suggests that the Neuspera Sacral Neuromodulation System is effective for overactive bladder?
Research has shown that the Neuspera Sacral Neuromodulation (SNM) System, which participants in this trial will receive, effectively treats urinary urge incontinence (UUI). One study found that the Neuspera device performs as well as traditional devices, which are currently the best treatments available for this condition. This means it is about as effective as the top existing options. Importantly, the Neuspera system achieves this without some drawbacks of older devices. Six-month trial data confirmed its effectiveness, and the device has received FDA approval for treating UUI. This treatment is especially beneficial for people who haven't had success with other options.12467
Who Is on the Research Team?
Osvaldo Padron, MD
Principal Investigator
Florida Urology Partners
Are You a Good Fit for This Trial?
This trial is for people who were part of the SANS-UUI Phase I or II study, specifically those with overactive bladder. It's a follow-up to see how they're doing after getting the Neuspera Sacral Neuromodulation System implanted.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation
Participants receive the Neuspera Sacral Neuromodulation System implant
Long-term Follow-up
Participants are monitored for safety and effectiveness of the Neuspera SNM System
What Are the Treatments Tested in This Trial?
Interventions
- Neuspera Sacral Neuromodulation System
Trial Overview
The focus is on the long-term safety and effectiveness of the Neuspera Implantable Sacral Neuromodulation System, which helps control overactive bladder symptoms. This single-arm study involves participants from earlier phases post-commercial approval.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Long term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neuspera Medical, Inc.
Lead Sponsor
Citations
Neuspera Medical Announces Landmark Six-Month ...
Pivotal Study Data Show Comparable “Gold Standard” Efficacy to Traditional Sacral Neuromodulation (SNM) Devices – Eliminating Burdens of a ...
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 patients ...
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 ...
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 ...
Neuspera Sacral Neuromodulation System
The Neuspera SNM System is used to help treat urinary urge incontinence (UUI) for people who tried other options but did not find them helpful, could not handle.
Neuspera Medical, Inc. Reaches Significant Milestone
Clinical study data to evaluate the safety and efficacy of the Neuspera System for the treatment of urinary urge incontinence (UUI) will ...
Neuspera Medical | Implantable Medical Device Technology
Neuspera Medical is developing implantable medical device technology to improve the lives of patients battling chronic illness, particularly OAB.
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