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The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic Implantable Tibial Neuromodulation (TNM) System | Device | Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device. |
| Measure | Description | Time Frame |
|---|---|---|
| UUI Responder | Proportion of TNM subjects experiencing a reduction of 50% or more in daily urinary urge incontinence (UUI) episodes (UUI responder rate) at 6 months after device implant. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| UUI Change From Baseline | Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline. | 6 months |
| UF Change From Baseline | Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mylene Champs | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209 | United States | ||
| Georgia Urology |
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Eligible subjects who signed the study-specific informed consent form (ICF) were considered enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Subjects | Eligible subjects who signed the study-specific informed consent form (ICF) were considered enrolled in the study. |
| 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 | Jul 18, 2022 | Oct 10, 2025 |
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| 6 months |
| UPS Change at 6 Months | Change in urinary urgency assessed through the UPS at 6 months compared to baseline. The UPS (Urgency Perception Scale) was developed to assess urgency associated with overactive bladder (OAB). The UPS is a single question assessed at each visit and has 3 options for responses: 1, 'I am usually not able to hold urine'; 2, 'I am usually able to hold urine until I reach the toilet if I go immediately'; and 3, 'I am usually able to finish what I am doing before going to the toilet'. Change from baseline is calculated by subtracting the baseline value from the follow-up value. Therefore, the change can range from -2 to 2 (with positive change indicating an improvement). | 6 months |
| OAB-q Change From Baseline | Change in Overactive Bladder Quality of Life Questionnaire (OAB-q) health related quality of life (HRQL) Total Score at 6 months compared to baseline. Details related to OAB-Q HRQL: OAB-q HRQL minimum value total score: 33 OAB-q HRQL maximum value total score:198 A positive change in OAB-q HRQL score represents an improvement. | 6 months |
| Cartersville |
| Georgia |
| 30120 |
| United States |
| Northwestern Medicine | Chicago | Illinois | 60611 | United States |
| Providea Health Partners | Evergreen Park | Illinois | 60805 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Louisiana State University Health Sciences Center | New Orleans | Louisiana | 70006 | United States |
| Chesapeake Urology Associates | Towson | Maryland | 21204 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Michigan Institute of Urology | Troy | Michigan | 48084 | United States |
| Minnesota Urology | Plymouth | Minnesota | 55441 | United States |
| Mayo Clinic Urology | Rochester | Minnesota | 55905 | United States |
| Summit Health Englewood | Englewood | New Jersey | 07631 | United States |
| Summit Health Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Associated Medical Professionals | Syracuse | New York | 13210 | United States |
| Atrium Health Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Alliance Urology Specialists | Greensboro | North Carolina | 27403 | United States |
| FirstHealth Urogynecology | Hamlet | North Carolina | 28345 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Wright State Physicians | Fairborn | Ohio | 45234 | United States |
| Central Ohio Urology Group | Gahanna | Ohio | 43230 | United States |
| Urology Surgeons of Oklahoma | Oklahoma City | Oklahoma | 73120 | United States |
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic | Sioux Falls | South Dakota | 57105 | United States |
| Urology Partners of North Texas Research Institute | Arlington | Texas | 46017 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Ascension Columbia St. Mary's | Milwaukee | Wisconsin | 53211 | United States |
| Implanted |
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| Day 7 |
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| Month 1 |
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| Month 2 |
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| Month 3 |
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| Month 6 |
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| Month 12 |
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| Month 24 |
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| COMPLETED |
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| NOT COMPLETED |
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All Implanted analysis set: Includes subjects who were implanted.
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| ID | Title | Description |
|---|---|---|
| BG000 | Implanted Subjects | Includes subjects who were implanted |
| 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 |
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| Region of Enrollment | Number | participants |
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| 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 | UUI Responder | Proportion of TNM subjects experiencing a reduction of 50% or more in daily urinary urge incontinence (UUI) episodes (UUI responder rate) at 6 months after device implant. | Includes subjects who were implanted and had data available at baseline and 6 months | Posted | Count of Participants | Participants | 6 months |
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| Secondary | UUI Change From Baseline | Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline. | Includes subjects who were implanted and had data available at baseline and 6 months | Posted | Mean | Standard Deviation | UUI episodes (per day) | 6 months |
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| Secondary | UF Change From Baseline | Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline. | Includes subjects who were implanted and had data available at baseline and 6 months | Posted | Mean | Standard Deviation | UF episodes (per day) | 6 months |
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| Secondary | UPS Change at 6 Months | Change in urinary urgency assessed through the UPS at 6 months compared to baseline. The UPS (Urgency Perception Scale) was developed to assess urgency associated with overactive bladder (OAB). The UPS is a single question assessed at each visit and has 3 options for responses: 1, 'I am usually not able to hold urine'; 2, 'I am usually able to hold urine until I reach the toilet if I go immediately'; and 3, 'I am usually able to finish what I am doing before going to the toilet'. Change from baseline is calculated by subtracting the baseline value from the follow-up value. Therefore, the change can range from -2 to 2 (with positive change indicating an improvement). | Includes subjects who were implanted and had data available at baseline and 6 months | Posted | Mean | Standard Deviation | Score on Urgency Perception Scale | 6 months |
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| Secondary | OAB-q Change From Baseline | Change in Overactive Bladder Quality of Life Questionnaire (OAB-q) health related quality of life (HRQL) Total Score at 6 months compared to baseline. Details related to OAB-Q HRQL: OAB-q HRQL minimum value total score: 33 OAB-q HRQL maximum value total score:198 A positive change in OAB-q HRQL score represents an improvement. | Includes subjects who were implanted and had data available at baseline and 6 months | Posted | Mean | Standard Deviation | OAB-q HRQL Total Score | 6 months |
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AEs were collected throughout the study once the informed consent form was signed. This results section is showing the AEs that happened at or after implant through 24-month follow-up visit.
For this study, all adverse events (AE) were collected regardless of relationship to the neurostimulator, external device, procedure, study aid, or therapy.
Notes: The 1 death that happened in the Study was not related to the neurostimulator, external device, procedure, study aid, or therapy. Only 1 of the serious Adverse event was related (Clostridium difficile colitis).
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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 | Implanted Subjects | All Implanted analysis set: Includes subjects who were implanted | 1 | 126 | 35 | 126 | 81 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Escherichia bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| Marginal zone lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Acute psychosis | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Cerebral artery stenosis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Lumbar radiculopathy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Multiple sclerosis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| Acute left ventricular failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Arrhythmia supraventricular | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Atrioventricular node dysfunction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Intestinal resection | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mylene Champs | Medtronic | 7635261627 | mylene.champs@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2023 | Oct 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009367 | Neoplasm Staging |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D011379 | Prognosis |
| D003933 | Diagnosis |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Unknown or Not Reported |
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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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