Clinical trial NCT04232696: Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Official title: Clinical Study of Neuspera's Implantable Sacral Nerve Stimulation (SNS) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urinary Urgency Incontinence
Keywords: UUI
Lead sponsor: Neuspera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 242
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, seamless two-phased pivotal study design.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phase II Primary Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence episodes.
timeFrame: Six months
measure: Phase II Primary Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up.
timeFrame: Six months
Secondary outcomes:
measure: 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.
timeFrame: 6 and 12 months
measure: Phase II Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence.
timeFrame: 12 months
measure: Phase II Urgent Voids per Day
timeFrame: 6 and 12 months
measure: Phase !! Change in Average Number of Daily Voids
timeFrame: 6 and 12 months
measure: Phase II Comprehensive Summary of all Adverse Events
timeFrame: 6 and 12 months
measure: Phase II Device Parameter Information Collected
timeFrame: 6 and 12 months
measure: Phase II Physician and Subject User Experience Questionnaire
timeFrame: 6 and 12 months
measure: Phase II Urinary Tract Symptoms Questionnaire: International Consultation on Incontinence Questionnaire Female & Male Lower Urinary Tract Symptoms Modules
timeFrame: 6 and 12 months
measure: Phase II Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up.
timeFrame: 12 months
measure: Phase II Urinary Output
timeFrame: 6 and 12 months
measure: Phase II Fecal Incontinence Measured by Wexner Scale
timeFrame: 6 and 12 months
measure: Phase II Patient Global Impression of Improvement
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Genesis Healthcare Partners
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente, LAMC
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners, LLC
state: Florida
city: Atlanta
country: United States
facility: Midtown Urology
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Lake Barrington
country: United States
facility: Comprehensive Urologic Care
state: Illinois
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Louisville
country: United States
facility: UofL Health System (University of Louisville)
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical
state: Louisiana
city: Wyoming
country: United States
facility: University of Michigan Health - West
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Urology
state: Minnesota
city: Saint Louis
country: United States
facility: Specialty Research of St. Louis
state: Missouri
city: Omaha
country: United States
facility: Adult & Pediatric Urology P.C.
state: Nebraska
city: New York City
country: United States
facility: Weill Cornell Medical College
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY
state: New York
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic Urogynecology West
state: Oregon
city: North Wales
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Southern shores urogynecology
state: South Carolina
city: West Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
city: Franklin
country: United States
facility: Center for Pelvic Health
state: Tennessee
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas (Dallas Center for Pelvic Medicine)
state: Texas
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Antwerp
country: Belgium
facility: Universiteit Antwerpen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Florida Urology Partners
name: Osvaldo Padron, MD
role: PRINCIPAL_INVESTIGATOR
References: