Urinary Urgency IncontinenceNCT04232696
Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
A study testing Neuspera Implantable Sacral Nerve Stimulation System in people with Urinary Urgency Incontinence, run by Neuspera Medical, Inc. at 34 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Urinary Urgency Incontinence
- What is being tested?
- Neuspera Implantable Sacral Nerve Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 34 sitesin 3 countries
- Study dates
- 13 Dec 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
United States31 sites
Midtown Urology
Atlanta, Georgia, 95816
Urology Austin
Austin, Texas, 78745
MetroHealth
Cleveland, Ohio, 44109
Urology Clinics of North Texas (Dallas Center for Pelvic Medicine)
Dallas, Texas, 75231
Genesis Healthcare Partners
Encinitas, California, 92024
Women's Health Advantage
Fort Wayne, Indiana, 46825
Center for Pelvic Health
Franklin, Tennessee, 37067
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Kansas Hospital
Kansas City, Kansas, 66103-2937
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010
Kaiser Permanente, LAMC
Los Angeles, California, 90027
UofL Health System (University of Louisville)
Louisville, Kentucky, 40202
University of Minnesota
Minneapolis, Minnesota, 55455
Southern shores urogynecology
Myrtle Beach, South Carolina, 29572
Ochsner Medical
New Orleans, Louisiana, 70121
Weill Cornell Medical College
New York, New York, 10065
The Institute for Female Pelvic Medicine and Reconstructive Surgery
North Wales, Pennsylvania, 19454
Adult & Pediatric Urology P.C.
Omaha, Nebraska, 68114
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
The Oregon Clinic Urogynecology West
Portland, Oregon, 97225
Premier Medical Group
Poughkeepsie, New York, 12603
Kaiser Permanente
San Diego, California, 92119
Meridian Clinical Research
Savannah, Georgia, 31406
Virginia Mason
Seattle, Washington, 98101
University of Washington
Seattle, Washington, 98133
Specialty Research of St. Louis
St Louis, Missouri, 63141
Associated Medical Professionals of NY
Syracuse, New York, 13210
Florida Urology Partners, LLC
Tampa, Florida, 33615
Southern Urogynecology
West Columbia, South Carolina, 29169
Minnesota Urology
Woodbury, Minnesota, 55125
University of Michigan Health - West
Wyoming, Michigan, 49519
Netherlands2 sites
Maastricht University Medical Center
Maastricht
Erasmus University Medical Center
Rotterdam
About this study
Official title: Clinical Study of Neuspera's Implantable Sacral Nerve Stimulation (SNS) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
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.
Read the 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.
- Conditions
- Urinary Urgency Incontinence
- Being tested
- Neuspera Implantable Sacral Nerve Stimulation System
- Keywords
- UUI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuspera Implantable Sacral Nerve Stimulation SystemDevice
Stimulation of the Sacral Nerve.
| Study group | Role | What they receive |
|---|---|---|
| Neuspera Implantable Sacral Nerve Stimulation System | Experimental | Implantation of the stimulator. Receives: Device: Neuspera Implantable Sacral Nerve Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Change from baseline in qualify of life. Total score (25 min,160 max) with higher score indicating increase impact on quality of life.
Measured: 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.
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.
Measured: 12 months
Phase II Urgent Voids Per Day
Change in urgent voids per day from baseline to 6-months and 12 months. Calculated across all diary episodes with at least mild urgency.
Measured: 6 and 12 months
Phase II Change in Average Number of Daily Voids
Change in average number of daily voids from baseline in subjects with at least 8 voids at baseline.
Measured: 6 and 12 months
Phase II Comprehensive Summary of All Adverse Events
The incidence of adverse events will be reported.
Measured: 6 and 12 months
Phase II Device Parameter Information Collected
Device amplitude will be collected in volts.
Measured: 6 and 12 months
Phase II Physician and Subject User Experience Questionnaire
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.
Measured: 6 and 12 months
Phase II Urinary Tract Symptoms Questionnaire: International Consultation on Incontinence Questionnaire Female & Male Lower Urinary Tract Symptoms Modules
Change in 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.
Measured: 6 and 12 months
Phase II Safety Endpoint: Defined as the Incidence of Device-related Serious Adverse Events in the Post-trial Period Follow-up.
The number of serious adverse events related to the device.
Measured: 12 months
Phase II Urinary Output
Total urinary output as measured by 72-hour bladder diary.
Measured: 6 and 12 months
Phase II Fecal Incontinence Measured by Wexner Scale
Wexner scale total points 0-20, higher the score the worse the outcome. Fecal incontinence as measured by the Wexner Scale compared to baseline.
Measured: 6 months
Phase II Patient Global Impression of Improvement
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start13 Dec 2019
- Primary completion17 Jul 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Urgency IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuspera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Osvaldo Padron, MD, Principal investigator, Florida Urology Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232696
- Sponsor's protocol ID
- Neuspera Medical (NSM)-004
- Other IDs
- SANS-UUI
- Status last verified
- Oct 2025
- First submitted
- 9 Dec 2019
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: At this time, there is no plan to share information.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Neuspera's Implantable Sacral Nerve Stimulation (SNS) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
- ClinicalTrials.gov ID
- NCT04232696
- Acronym / sponsor ID
- Neuspera Medical (NSM)-004
- Conditions
- Urinary Urgency Incontinence
- Keywords
- UUI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Neuspera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 3 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neuspera Implantable Sacral Nerve Stimulation System | Experimental | Device: Neuspera Implantable Sacral Nerve Stimulation SystemImplantation of the stimulator. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuspera Implantable Sacral Nerve Stimulation SystemStimulation of the Sacral Nerve. | Device | Neuspera Implantable Sacral Nerve Stimulation System |
Primary outcome
Primary Efficacy Endpoint: Percentage of Participants Who Experience a 50 Percent or More Change in Urinary Urgency Incontinence Episodes.
Time frame: 6 months
Change in Urinary Urgency Incontinence episodes at six months, relative to the number of Urinary Urgency Incontinence episodes at baseline.
Primary Safety Endpoint: Defined as the Proportion of Subjects Experiencing a Device-related Serious Adverse Events.
Time frame: 6 months
The analysis of the endpoint is the proportion of subjects experiencing a device-related SAE through the 6-month post-implant.
12 secondary outcomes
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.
Time frame: 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.
Time frame: 12 months
Phase II Urgent Voids Per Day
Time frame: 6 and 12 months
Phase II Change in Average Number of Daily Voids
Time frame: 6 and 12 months
Phase II Comprehensive Summary of All Adverse Events
Time frame: 6 and 12 months
Phase II Device Parameter Information Collected
Time frame: 6 and 12 months
Phase II Physician and Subject User Experience Questionnaire
Time frame: 6 and 12 months
Phase II Urinary Tract Symptoms Questionnaire: International Consultation on Incontinence Questionnaire Female & Male Lower Urinary Tract Symptoms Modules
Time frame: 6 and 12 months
Phase II Safety Endpoint: Defined as the Incidence of Device-related Serious Adverse Events in the Post-trial Period Follow-up.
Time frame: 12 months
Phase II Urinary Output
Time frame: 6 and 12 months
Phase II Fecal Incontinence Measured by Wexner Scale
Time frame: 6 months
Phase II Patient Global Impression of Improvement
Time frame: 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Neuspera Medical web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. At this time, there is no plan to share information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osvaldo Padron, MD principal investigator
Florida Urology Partners
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuspera Implantable Sacral Nerve Stimulation System in people with Urinary Urgency Incontinence, run by Neuspera Medical, Inc. at 34 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: Percentage of Participants Who Experience a 50 Percent or More Change in Urinary Urgency Incontinence Episodes. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.