What side effects are associated with this type of intervention?

Sacral Nerve Stimulation (SNS) for urinary incontinence, such as the Neuspera SNS System, commonly involves side effects like pain at the implant site, infection, lead migration, and technical issues with the device. Other potential side effects include urinary retention, changes in bowel function, and discomfort during stimulation. These side effects are generally manageable but should be discussed with a healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

The FDA has approved several treatments for urinary incontinence that involve electrical stimulation of the sacral nerves. One notable example is the InterStim Therapy System by Medtronic, which uses sacral nerve stimulation (SNS) to modulate bladder function and has been approved for treating overactive bladder and urinary retention. Another example is the Axonics Sacral Neuromodulation System, which also targets sacral nerves to improve bladder control. These devices work by delivering mild electrical pulses to the sacral nerves, helping to restore normal bladder function and reduce symptoms of urinary incontinence.

What other types of research exist?

Promising alternatives to the Neuspera Sacral Nerve Stimulation (SNS) System for urinary incontinence include: 1) Percutaneous Tibial Nerve Stimulation (PTNS), which involves electrical stimulation of the tibial nerve to improve bladder function. 2) Transcutaneous Electrical Nerve Stimulation (TENS), which uses surface electrodes to provide electrical impulses and has shown some efficacy in managing urinary incontinence. 3) Advanced Spinal Cord Stimulation (SCS) techniques, which are being explored for their potential to modulate bladder function. These alternatives offer different approaches to neuromodulation and may provide effective treatment options for patients.

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Device

Sacral Nerve Stimulation for Urinary Incontinence

N/A

Waitlist Available

Research Sponsored by Neuspera Medical, Inc.

Eligibility Criteria Checklist

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

Must have

Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimum of one (1) UUI episode per 24-hour period.

Has failed or was not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification).

Must not have

Has a hemoglobin A1c of greater than 8 percent, or has diabetes mellitus with glucosuria.

Has clinically significant bladder outlet obstruction.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

Summary

This trial tests a small implantable device that sends electrical signals to nerves in the lower back to help people with bladder control issues who haven't been helped by other treatments. The study will check how well this device works and how safe it is.

Who is the study for?

This trial is for individuals with Urinary Urgency Incontinence (UUI) who haven't had success with or can't handle standard treatments. Participants should have a BMI between 18 and 40, have struggled with UUI for at least 6 months, and experience frequent UUI episodes. People are excluded if they have certain conditions like uncontrolled diabetes, urinary retention history, bladder obstructions, or specific neurological disorders.

What is being tested?

The Neuspera Implantable Sacral Nerve Stimulation System is being tested in two phases to see how well it works and how safe it is for treating UUI. Phase I will determine the daily stimulation duration needed while Phase II will evaluate the system's effectiveness after six months and safety after twelve months.

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort at the implant site, infection risk from surgery, nerve damage symptoms such as pain or changes in sensation, and possible malfunction of the device.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with urge urinary incontinence, experiencing at least 4 episodes in 3 days.

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I have tried or cannot try basic treatments like pelvic exercises.

Exclusion Criteria

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

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My A1c level is above 8%, or I have diabetes with sugar in my urine.

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I have a serious blockage in my bladder.

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I have a blockage caused by an enlarged prostate, narrowing of the urethra, or cancer.

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I have chronic bladder pain or frequent urinary infections.

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I have nerve damage due to diabetes.

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I have bladder issues due to a nerve problem from conditions like MS or Parkinson's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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.

Primary study objectives

Phase II Primary Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence episodes.

Phase II Primary Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up.

Secondary study objectives

Phase !! Change in Average Number of Daily Voids

Phase II Change in Quality of Life: Measured from baseline as measured and assessed by the total and subset International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life score.

Phase II Comprehensive Summary of all Adverse Events

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Trial Design

1Treatment groups

Experimental Treatment

Group I: Neuspera Implantable Sacral Nerve Stimulation SystemExperimental Treatment1 Intervention

Implantation of the simulator.

0 / 8Eligibility 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

Sacral Nerve Stimulation (SNS) works by delivering mild electrical impulses to the sacral nerves, which are responsible for controlling bladder function. These impulses help modulate the neural pathways that influence bladder storage and voiding reflexes, thereby improving symptoms of urinary urgency, frequency, and incontinence. This treatment is particularly significant for patients who have not responded to conservative therapies, as it offers a minimally invasive option that can enhance bladder control and improve quality of life.

Sacral nerve stimulation for urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence: an evidence-based analysis.