Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgen… (NCT04232696) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
United States331 participantsStarted 2019-12-13
Plain-language summary
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.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Has a Body Mass Index (BMI) between 18 and 40.
✓. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.
✓. Has failed or was not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification).
✓. 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.
✓. 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
✕. Has a hemoglobin A1c of greater than 8 percent, or has diabetes mellitus with glucosuria.
✕. Has diabetic neuropathy.
✕. 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.
What they're measuring
1
Primary Efficacy Endpoint: Percentage of Participants Who Experience a 50 Percent or More Change in Urinary Urgency Incontinence Episodes.
Timeframe: 6 months
2
Primary Safety Endpoint: Defined as the Proportion of Subjects Experiencing a Device-related Serious Adverse Events.
✕. Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident.
✕. Has documented urinary retention within 6 months prior to the screening baseline visit date.
✕. Has clinically significant bladder outlet obstruction.
✕. Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture or cancer.
✕. 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.