Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
NCT ID: NCT04232696
Last Updated: 2025-11-03
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
331 participants
INTERVENTIONAL
2019-12-13
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
Phase I enrolled 89 subjects and Phase II enrolled 242 subjects.
TREATMENT
NONE
Study Groups
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Neuspera Implantable Sacral Nerve Stimulation System
Implantation of the stimulator.
Neuspera Implantable Sacral Nerve Stimulation System
Stimulation of the Sacral Nerve.
Interventions
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Neuspera Implantable Sacral Nerve Stimulation System
Stimulation of the Sacral Nerve.
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
No
Sponsors
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Neuspera Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Osvaldo Padron, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Urology Partners
Locations
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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
Southern Urogynecology
West Columbia, South Carolina, United States
Center for Pelvic Health
Franklin, Tennessee, United States
Urology Austin
Austin, Texas, United States
Urology Clinics of North Texas (Dallas Center for Pelvic Medicine)
Dallas, Texas, United States
Virginia Mason
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Universiteit Antwerpen
Antwerp, , Belgium
Maastricht University Medical Center
Maastricht, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Neuspera Medical web page
Other Identifiers
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SANS-UUI
Identifier Type: OTHER
Identifier Source: secondary_id
Neuspera Medical (NSM)-004
Identifier Type: -
Identifier Source: org_study_id
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