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| ID | Type | Description | Link |
|---|---|---|---|
| SANS-UUI | Other Identifier | Neuspera |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuspera Implantable Sacral Nerve Stimulation System | Experimental | Implantation of the stimulator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuspera Implantable Sacral Nerve Stimulation System | Device | Stimulation of the Sacral Nerve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osvaldo Padron, MD | Florida Urology Partners | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Healthcare Partners | Encinitas | California | 92024 | United States | ||
| Kaiser Permanente, LAMC |
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| Label | URL |
|---|---|
| Neuspera Medical web page | View source |
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At this time, there is no plan to share information.
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Ph I Study: Of 89 subjects consented, 39 subjects had implant attempted, 34 were successfully implanted. 35 subjects were screen failures, 11 withdrew consent, 1 withdrawn by investigator, 2 LTF, and 1 other withdrawal reason. Ph II Study: Of 242 subjects consented, 130 subjects had implant attempted and 128 were successfully implanted. 80 subjects were screen failure,16 withdrew consent, 3 withdrawn by investigator, 5 LTF, 4 due to site termination by sponsor, and 4 other withdrawal reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I, Neuspera Implantable Sacral Nerve Stimulation System | Implantation of the Stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve. |
| FG001 | Phase II, Neuspera Implantable Sacral Nerve Stimulation System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2025 | Jun 26, 2025 |
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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.
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| 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. | 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. | 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. | 6 and 12 months |
| Phase II Comprehensive Summary of All Adverse Events | The incidence of adverse events will be reported. | 6 and 12 months |
| Phase II Device Parameter Information Collected | Device amplitude will be collected in volts. | 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. | 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. | 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. | 12 months |
| Phase II Urinary Output | Total urinary output as measured by 72-hour bladder diary. | 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. | 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. | 6 and 12 months |
| Los Angeles |
| California |
| 90027 |
| United States |
| Kaiser Permanente | San Diego | California | 92119 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| Florida Urology Partners, LLC | Tampa | Florida | 33615 | United States |
| Midtown Urology | Atlanta | Georgia | 95816 | United States |
| Meridian Clinical Research | Savannah | Georgia | 31406 | United States |
| Comprehensive Urologic Care | Lake Barrington | Illinois | 60010 | United States |
| Women's Health Advantage | Fort Wayne | Indiana | 46825 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66103-2937 | United States |
| UofL Health System (University of Louisville) | Louisville | Kentucky | 40202 | United States |
| Ochsner Medical | New Orleans | Louisiana | 70121 | United States |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Minnesota Urology | Woodbury | Minnesota | 55125 | United States |
| Specialty Research of St. Louis | St Louis | Missouri | 63141 | United States |
| Adult & Pediatric Urology P.C. | Omaha | Nebraska | 68114 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Premier Medical Group | Poughkeepsie | New York | 12603 | United States |
| Associated Medical Professionals of NY | Syracuse | New York | 13210 | United States |
| MetroHealth | Cleveland | Ohio | 44109 | United States |
| The Oregon Clinic Urogynecology West | Portland | Oregon | 97225 | United States |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery | North Wales | Pennsylvania | 19454 | United States |
| Southern shores urogynecology | Myrtle Beach | South Carolina | 29572 | United States |
| Southern Urogynecology | West Columbia | South Carolina | 29169 | United States |
| Center for Pelvic Health | Franklin | Tennessee | 37067 | United States |
| Urology Austin | Austin | Texas | 78745 | United States |
| Urology Clinics of North Texas (Dallas Center for Pelvic Medicine) | Dallas | Texas | 75231 | United States |
| Virginia Mason | Seattle | Washington | 98101 | United States |
| University of Washington | Seattle | Washington | 98133 | United States |
| Universiteit Antwerpen | Antwerp | Belgium |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Erasmus University Medical Center | Rotterdam | Netherlands |
Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve. |
| COMPLETED | 6 month primary endpoint timepoint |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: Neuspera Implantable Sacral Nerve Stimulation System | Implantation of the simulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve. |
| BG001 | Phase II: Neuspera Implantable Sacral Nerve Stimulation System | Implantation of the simulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Completers data: number of subjects with completed assessments for primary endpoint | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| ||||||||||||||||||||||||||||
| Primary | 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. | All enrolled subjects | Posted | Count of Participants | Participants | 6 months |
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| ||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 6 and 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 6 and 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 6 and 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Phase II Comprehensive Summary of All Adverse Events | The incidence of adverse events will be reported. | Not Posted | 6 and 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Phase II Device Parameter Information Collected | Device amplitude will be collected in volts. | Not Posted | 6 and 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 6 and 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 6 and 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Phase II Urinary Output | Total urinary output as measured by 72-hour bladder diary. | Not Posted | 6 and 12 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 6 months | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 6 and 12 months | Participants |
At least 6 months post-implant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ph I, Neuspera Implantable Sacral Nerve Stimulation System | Phase I, Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve. | 0 | 39 | 1 | 39 | 10 | 39 |
| EG001 | Ph II, Neuspera Implantable Sacral Nerve Stimulation System | Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve. | 0 | 130 | 16 | 130 | 0 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Appendicitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Breast Cellulitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Fall | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Post procedural stroke | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment | Possibly related to the implant procedure |
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| Shoulder arthroplasty | Surgical and medical procedures | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Shoulder Operation | Surgical and medical procedures | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Numbness and tingling in left foot | Nervous system disorders | MedDRA (25.0) | Systematic Assessment | Not related to Study Device or Study Procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant Site Pain | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Device Dislocation | Product Issues | MedDRA (25.0) | Systematic Assessment |
| |
| Device Breakage | Product Issues | MedDRA (25.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Vollmer | Neuspera Clinical Research | 612-281-4875 | mark.vollmer@neuspera.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2024 | Jun 26, 2025 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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