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

NCT04232696 | Active Not Recruiting Results DMC FDA Device

• 2 other identifiers: Neuspera Medical (NSM)-004SANS-UUI
• Study Type: interventional
• Target: 331
• Locations: 3 countries
• Sites: 34

Brief 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.

Conditions

Urinary Urgency Incontinence

Keywords

UUI

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint: Percentage of Participants Who Experience a 50 Percent or More Change in Urinary Urgency Incontinence Episodes.

  Change in Urinary Urgency Incontinence episodes at six months, relative to the number of Urinary Urgency Incontinence episodes at baseline.

  6 months

• Primary Safety Endpoint: Defined as the Proportion of Subjects Experiencing a Device-related Serious Adverse Events.

  The analysis of the endpoint is the proportion of subjects experiencing a device-related SAE through the 6-month post-implant.

  6 months

Secondary Outcomes (12)

• 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.

  6 and 12 months

• Phase II Efficacy Endpoint: Defined as the Percentage of Participants Who Experience a 50 Percent or More Change in Urinary Urgency Incontinence.

  12 months

• Phase II Urgent Voids Per Day

  6 and 12 months

• Phase II Change in Average Number of Daily Voids

  6 and 12 months

• Phase II Comprehensive Summary of All Adverse Events

  6 and 12 months

Study Arms (1)

Neuspera Implantable Sacral Nerve Stimulation System

EXPERIMENTAL

Implantation of the stimulator.

Device: Neuspera Implantable Sacral Nerve Stimulation System

Interventions

Neuspera Implantable Sacral Nerve Stimulation System DEVICE

Stimulation of the Sacral Nerve.

Neuspera Implantable Sacral Nerve Stimulation System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Neuspera Medical, Inc.: lead

Study Sites (34)

Genesis Healthcare Partners

Encinitas, California, 92024, United States

Location

Kaiser Permanente, LAMC

Los Angeles, California, 90027, United States

Location

Kaiser Permanente

San Diego, California, 92119, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Florida Urology Partners, LLC

Tampa, Florida, 33615, United States

Location

Midtown Urology

Atlanta, Georgia, 95816, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Comprehensive Urologic Care

Lake Barrington, Illinois, 60010, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66103-2937, United States

Location

UofL Health System (University of Louisville)

Louisville, Kentucky, 40202, United States

Location

Ochsner Medical

New Orleans, Louisiana, 70121, United States

Location

University of Michigan Health - West

Wyoming, Michigan, 49519, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Minnesota Urology

Woodbury, Minnesota, 55125, United States

Location

Specialty Research of St. Louis

St Louis, Missouri, 63141, United States

Location

Adult & Pediatric Urology P.C.

Omaha, Nebraska, 68114, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Premier Medical Group

Poughkeepsie, New York, 12603, United States

Location

Associated Medical Professionals of NY

Syracuse, New York, 13210, United States

Location

MetroHealth

Cleveland, Ohio, 44109, United States

Location

The Oregon Clinic Urogynecology West

Portland, Oregon, 97225, United States

Location

The Institute for Female Pelvic Medicine and Reconstructive Surgery

North Wales, Pennsylvania, 19454, United States

Location

Southern shores urogynecology

Myrtle Beach, South Carolina, 29572, United States

Location

Southern Urogynecology

West Columbia, South Carolina, 29169, United States

Location

Center for Pelvic Health

Franklin, Tennessee, 37067, United States

Location

Urology Austin

Austin, Texas, 78745, United States

Location

Urology Clinics of North Texas (Dallas Center for Pelvic Medicine)

Dallas, Texas, 75231, United States

Location

Virginia Mason

Seattle, Washington, 98101, United States

Location

University of Washington

Seattle, Washington, 98133, United States

Location

Universiteit Antwerpen

Antwerp, Belgium

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Related Links

• Neuspera Medical web page

Results Point of Contact

• Title: Mark Vollmer
• Organization: Neuspera Clinical Research

mark.vollmer@neuspera.com

612-281-4875

Study Officials

• Osvaldo Padron, MD

  Florida Urology Partners

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, seamless two-phased pivotal study design. Phase I is designed to assess the initial feasibility of Neuspera's Implantable SNS System and to determine optimal daily stimulation parameters for Phase II. The data from Phase I informed the duration of daily stimulation and was applied in Phase II, which aims to evaluate the safety and efficacy of the system. Phase I and Phase II involve distinct patient populations with no overlap. Phase I enrolled 89 subjects and Phase II enrolled 242 subjects.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: January 18, 2020
• Study Start: December 13, 2019
• Primary Completion: July 17, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); US (31); BE (1)