Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

Clinical Study of Neuspera's Implantable Sacral Nerve Stimulation (SNS) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

Prospective, multi-center, single-arm, seamless phase-pivotal study conducted in participants diagnosed with UUI who have failed or could not tolerate more conservative treatment. The trial will be conducted in two phases.

Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial.

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 safety and efficacy endpoints.

Neuspera's Implantable Sacral Nerve Stimulation (SNS) System is indicated to treat participants with UUI who have failed or could not tolerate more conservative treatments.

The study will be conducted in two phases: Phase I of the study will be conducted at up to 9 clinical study sites in the US and Europe. Phase II of the study will be conducted in up to 35 clinical sites in the US and Europe, inclusive of the Phase I centers.

Prospective, multi-center, single-arm, seamless phase-pivotal study. Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial.

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 safety and efficacy endpoints. All participants will receive the same length of device stimulation as determined in Phase I testing.

Phase I will enroll up to 55 participants. Phase II will enroll up to 255 participants.

Inclusion Criteria:

1. Has a Body Mass Index (BMI) between 18 and 40.
2. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.
3. Has failed or was not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification).
4. Has failed or could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects) or not a good candidate for (as determined by treating physician) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.
5. 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.

Exclusion Criteria:

1. Has a hemoglobin A1c of greater than 8 percent, or has diabetes mellitus with glucosuria.
2. Has diabetic neuropathy.
3. Has interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines, chronic pelvic pain or recurrent symptomatic urinary tract infections.
4. Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident.
5. Has documented urinary retention within 6 months prior to the screening baseline visit date.
6. Has clinically significant bladder outlet obstruction.
7. Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture or cancer.
8. Has primary stress incontinence or mixed incontinence where the stress component predominates or has been treated surgically for stress urinary incontinence within 6 months prior to the screening baseline visit date.
9. Has received tibial nerve stimulation (TNS) in the past 3 months for the treatment of overactive bladder or unwilling to stay off TNS therapy for 12-month period following implant.