Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
- Conditions
- Urinary Urgency Incontinence
- Interventions
- Device: Neuspera Implantable Sacral Nerve Stimulation System
- Registration Number
- NCT04232696
- Lead Sponsor
- Neuspera Medical, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 242
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neuspera Implantable Sacral Nerve Stimulation System Neuspera Implantable Sacral Nerve Stimulation System Implantation of the simulator.
- Primary Outcome Measures
Name Time Method Phase II Primary Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up. Six months The number of serious adverse events related to the device.
Phase II Primary Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence episodes. Six months Change in Urinary Urgency Incontinence episodes at six months post-completion of the trial phase, relative to the number of Urinary Urgency Incontinence episodes at baseline prior to the trial phase.
- Secondary Outcome Measures
Name Time Method Phase !! Change in Average Number of Daily Voids 6 and 12 months Change in average number of daily voids from baseline in subjects with at least 8 voids at baseline.
Phase II Device Parameter Information Collected 6 and 12 months Device amplitude will be collected in volts.
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 Total score (25 min,160 max) with higher score indicating increase impact on quality of life.
Phase II Urgent Voids per Day 6 and 12 months Change in urgent voids per day from baseline to 6-months and 12 months. Calculated across all diary episodes with at least mild urgency.
Phase II Efficacy Endpoint: Defined as the percentage of participants who experience a 50 percent or more change in Urinary Urgency Incontinence. 12 months Change in Urinary Urgency Incontinence episodes at 12 months post-completion of the trial phase, relative to the number of Urinary Urgency Incontinence episodes at baseline prior to the trial phase.
Phase II Patient Global Impression of Improvement 6 and 12 months Patient Global Impression of Improvement measured after implant during follow-up. Single question answered on a seven point scale: very much better, much better, a little better, no change, a little worse, much worse, very much worse. Selection of very much better is the best outcome.
Phase II Comprehensive Summary of all Adverse Events 6 and 12 months The incidence of adverse events will be reported.
Phase II Fecal Incontinence Measured by Wexner Scale 6 and 12 months Fecal incontinence as measured by the Wexner Scale compared to baseline. Wexner scale total points 0-20, higher the score the worse the outcome.
Phase II Physician and Subject User Experience Questionnaire 6 and 12 months Physician and subject satisfaction will be obtained by answering questions on the use of the device using a five point scale:strongly agree, agree, neither agree nor disagree, disagree, strongly disagree. Answers towards strongly agree indicate a better outcome.
Phase II Safety Endpoint: Defined as the incidence of device-related serious adverse events in the post-trial period follow-up. 12 months The number of serious adverse events related to the device.
Phase II Urinary Tract Symptoms Questionnaire: International Consultation on Incontinence Questionnaire Female & Male Lower Urinary Tract Symptoms Modules 6 and 12 months Change in male/female lower urinary tract symptoms questionnaire. Male questionnaire score ranges from 0-52 and female questionnaire score ranges from 0-48. Higher number indicates worse outcome.
Phase II Urinary Output 6 and 12 months Total urinary output as measured by 72-hour bladder diary.
Trial Locations
- Locations (34)
Kaiser Permanente, LAMC
🇺🇸Los Angeles, California, United States
Meridian Clinical Research
🇺🇸Savannah, Georgia, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Weill Cornell Medical College
🇺🇸New York City, New York, United States
Center for Pelvic Health
🇺🇸Franklin, Tennessee, United States
Genesis Healthcare Partners
🇺🇸Encinitas, 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
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
MetroHealth
🇺🇸Cleveland, Ohio, United States
Minnesota Urology
🇺🇸Woodbury, Minnesota, United States
Specialty Research of St. Louis
🇺🇸Saint Louis, Missouri, United States
Adult & Pediatric Urology P.C.
🇺🇸Omaha, Nebraska, United States
Associated Medical Professionals of NY
🇺🇸Syracuse, New York, United States
Southern shores urogynecology
🇺🇸Myrtle Beach, South Carolina, United States
Southern Urogynecology
🇺🇸West Columbia, South Carolina, 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
Premier Medical Group
🇺🇸Poughkeepsie, New York, 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
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands