An interventional study of Medtronic Implantable Tibial Neuromodulation (TNM) System in Overactive Bladder, sponsored by MedtronicNeuro. Completed at 29 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by MedtronicNeuro (part of Medtronic) · Not applicable, Interventional, and Treatment
The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's enrollment of 188 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →MedtronicNeuro is the lead sponsor of 74 studies on the registry; 2 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.
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.
Time frame: 6 months
UUI Change From Baseline
Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.
Time frame: 6 months
UF Change From Baseline
Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.
Time frame: 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).
Time frame: 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.
Time frame: 6 months
Eligible subjects who signed the study-specific informed consent form (ICF) were considered enrolled in the study.
| Milestone | Enrolled Subjects |
|---|---|
| Started | 188 |
| Implanted | 126 |
| Day 7 | 126 |
| Month 1 | 125 |
| Month 2 | 125 |
| Month 3 | 125 |
| Month 6 | 125 |
| Month 12 | 120 |
| Month 24 | 104 |
| Completed | 104 |
| Not completed | 84 |
| Withdrew: Screen failures prior to implant | 62 |
| Withdrew: Withdrawal by subject | 13 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Physician decision | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Death | 1 |
| Withdrew: Device explant with no planned replacement | 1 |
| Withdrew: Planned surgery with an implanted metal material closer than allowed in research protocol | 1 |
| Withdrew: Transitioned to urethral catheter/suprapubic tube | 1 |
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.
| Participants | Implanted Subjects |
|---|---|
| UUI Responder | 72 |
Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.
| UUI episodes (per day) | Implanted Subjects |
|---|---|
| UUI Change From Baseline | -2.8 ± 3.12 |
Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.
| UF episodes (per day) | Subjects With Baseline UF |
|---|---|
| UF Change From Baseline | -2.6 ± 2.94 |
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).
| Score on Urgency Perception Scale | Implanted Subjects |
|---|---|
| UPS Change at 6 Months | 0.4 ± 0.74 |
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.
| OAB-q HRQL Total Score | Implanted Subjects |
|---|---|
| OAB-q Change From Baseline | 27.1 ± 25.79 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implanted Subjects | 1/126 (0.8%) | 35/126 (27.8%) | 81/126 (64.3%) |
| Event | Implanted Subjects |
|---|---|
| PyelonephritisInfections and infestations | 3/126 |
| Angina pectorisCardiac disorders | 3/126 |
| PneumoniaInfections and infestations | 2/126 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/126 |
| FallInjury, poisoning and procedural complications | 2/126 |
| BronchitisInfections and infestations | 1/126 |
| COVID-19 pneumoniaInfections and infestations | 1/126 |
| Clostridium difficile colitisInfections and infestations | 1/126 |
| Escherichia bacteraemiaInfections and infestations | 1/126 |
| GastroenteritisInfections and infestations | 1/126 |
| Event | Implanted Subjects |
|---|---|
| Urinary tract infectionInfections and infestations | 36/126 |
| COVID-19Infections and infestations | 30/126 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 15/126 |
| Back painMusculoskeletal and connective tissue disorders | 11/126 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 11/126 |
| NasopharyngitisInfections and infestations | 9/126 |
| ConjunctivitisInfections and infestations | 8/126 |
| FallInjury, poisoning and procedural complications | 8/126 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 7/126 |
All Implanted analysis set: Includes subjects who were implanted.
| Age, Continuous(years) | Implanted Subjects |
|---|---|
| Mean | 62.6 ± 13.68 |
| Sex: Female, Male(Participants) | Implanted Subjects |
|---|---|
| Female | 120 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Implanted Subjects |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 120 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Implanted Subjects |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 16 |
| White | 108 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Implanted Subjects |
|---|---|
| United States | 126 |
| BMI(kg/m2) | Implanted Subjects |
|---|---|
| Mean | 34.8 ± 8.61 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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