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

Running, not enrolling · Not applicable

Conditions studied: Urinary Urgency Incontinence

In brief

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.

Key facts

Study ID

NCT04232696

Run by

Neuspera Medical, Inc.

People needed

331

Starts

2019-12-13

Expected to finish

2026-12-01

Last updated by the study team

2025-11-03

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.
• 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.

Where it is running

• Genesis Healthcare Partners — Encinitas, California, United States
• Kaiser Permanente, LAMC — Los Angeles, California, United States
• Kaiser Permanente — San Diego, California, United States
• Clinical Research Center of Florida — Pompano Beach, Florida, United States
• Florida Urology Partners, LLC — Tampa, Florida, United States
• Midtown Urology — Atlanta, Georgia, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Comprehensive Urologic Care — Lake Barrington, Illinois, United States
• Women's Health Advantage — Fort Wayne, Indiana, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• UofL Health System (University of Louisville) — Louisville, Kentucky, United States
• Ochsner Medical — New Orleans, Louisiana, United States
• University of Michigan Health - West — Wyoming, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Minnesota Urology — Woodbury, Minnesota, United States
• Specialty Research of St. Louis — St Louis, Missouri, United States
• Adult & Pediatric Urology P.C. — Omaha, Nebraska, United States
• Weill Cornell Medical College — New York, New York, United States
• Premier Medical Group — Poughkeepsie, New York, United States
• Associated Medical Professionals of NY — Syracuse, New York, United States
• MetroHealth — Cleveland, Ohio, United States
• The Oregon Clinic Urogynecology West — Portland, Oregon, United States
• The Institute for Female Pelvic Medicine and Reconstructive Surgery — North Wales, Pennsylvania, United States
• Southern shores urogynecology — Myrtle Beach, South Carolina, United States

Full record on ClinicalTrials.gov

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