Trial Outcomes & Findings for Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2) (NCT NCT05226286)
NCT ID: NCT05226286
Last Updated: 2025-11-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
188 participants
Primary outcome timeframe
6 months
Results posted on
2025-11-21
Participant Flow
Eligible subjects who signed the study-specific informed consent form (ICF) were considered enrolled in the study.
Participant milestones
| Measure |
Enrolled Subjects
Eligible subjects who signed the study-specific informed consent form (ICF) were considered enrolled in the study.
|
|---|---|
|
Overall Study
STARTED
|
188
|
|
Overall Study
Implanted
|
126
|
|
Overall Study
Day 7
|
126
|
|
Overall Study
Month 1
|
125
|
|
Overall Study
Month 2
|
125
|
|
Overall Study
Month 3
|
125
|
|
Overall Study
Month 6
|
125
|
|
Overall Study
Month 12
|
120
|
|
Overall Study
Month 24
|
104
|
|
Overall Study
COMPLETED
|
104
|
|
Overall Study
NOT COMPLETED
|
84
|
Reasons for withdrawal
| Measure |
Enrolled Subjects
Eligible subjects who signed the study-specific informed consent form (ICF) were considered enrolled in the study.
|
|---|---|
|
Overall Study
Screen failures prior to implant
|
62
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Device explant with no planned replacement
|
1
|
|
Overall Study
Planned surgery with an implanted metal material closer than allowed in research protocol
|
1
|
|
Overall Study
Transitioned to urethral catheter/suprapubic tube
|
1
|
Baseline Characteristics
Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)
Baseline characteristics by cohort
| Measure |
Implanted Subjects
n=126 Participants
Includes subjects who were implanted
|
|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 13.68 • n=68 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
120 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=68 Participants
|
|
BMI
|
34.8 kg/m2
STANDARD_DEVIATION 8.61 • n=68 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Includes subjects who were implanted and had data available at baseline and 6 months
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.
Outcome measures
| Measure |
Implanted Subjects
n=123 Participants
Includes subjects who were implanted and had 6 month data available
|
|---|---|
|
UUI Responder
|
72 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Includes subjects who were implanted and had data available at baseline and 6 months
Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.
Outcome measures
| Measure |
Implanted Subjects
n=123 Participants
Includes subjects who were implanted and had 6 month data available
|
|---|---|
|
UUI Change From Baseline
|
-2.8 UUI episodes (per day)
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Includes subjects who were implanted and had data available at baseline and 6 months
Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.
Outcome measures
| Measure |
Implanted Subjects
n=59 Participants
Includes subjects who were implanted and had 6 month data available
|
|---|---|
|
UF Change From Baseline
|
-2.6 UF episodes (per day)
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Includes subjects who were implanted and had data available at baseline and 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).
Outcome measures
| Measure |
Implanted Subjects
n=125 Participants
Includes subjects who were implanted and had 6 month data available
|
|---|---|
|
UPS Change at 6 Months
|
0.4 Score on Urgency Perception Scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Includes subjects who were implanted and had data available at baseline and 6 months
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.
Outcome measures
| Measure |
Implanted Subjects
n=125 Participants
Includes subjects who were implanted and had 6 month data available
|
|---|---|
|
OAB-q Change From Baseline
|
27.1 OAB-q HRQL Total Score
Standard Deviation 25.79
|
Adverse Events
Implanted Subjects
Serious events: 35 serious events
Other events: 81 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Implanted Subjects
n=126 participants at risk
All Implanted analysis set: Includes subjects who were implanted
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Infections and infestations
Escherichia bacteraemia
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Infections and infestations
Gastroenteritis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Infections and infestations
Pneumonia
|
1.6%
2/126 • Number of events 2 • 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).
|
|
Infections and infestations
Post procedural infection
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Infections and infestations
Pyelonephritis
|
2.4%
3/126 • Number of events 4 • 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).
|
|
Infections and infestations
Sinusitis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma recurrent
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Psychiatric disorders
Acute psychosis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Nervous system disorders
Multiple sclerosis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Eye disorders
Retinal detachment
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Cardiac disorders
Acute left ventricular failure
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Cardiac disorders
Angina pectoris
|
2.4%
3/126 • Number of events 3 • 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).
|
|
Cardiac disorders
Angina unstable
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Cardiac disorders
Atrial fibrillation
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Cardiac disorders
Atrioventricular block
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Cardiac disorders
Atrioventricular node dysfunction
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Cardiac disorders
Bradycardia
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Cardiac disorders
Cardiac failure
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Cardiac disorders
Myocardial infarction
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Vascular disorders
Embolism
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Vascular disorders
Hypertensive crisis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Haematemesis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Melaena
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/126 • Number of events 2 • 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).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
2/126 • Number of events 2 • 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).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.79%
1/126 • Number of events 1 • 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).
|
|
Surgical and medical procedures
Intestinal resection
|
0.79%
1/126 • Number of events 1 • 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).
|
Other adverse events
| Measure |
Implanted Subjects
n=126 participants at risk
All Implanted analysis set: Includes subjects who were implanted
|
|---|---|
|
Infections and infestations
COVID-19
|
23.8%
30/126 • Number of events 30 • 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).
|
|
Infections and infestations
Conjunctivitis
|
6.3%
8/126 • Number of events 8 • 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).
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
9/126 • Number of events 10 • 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).
|
|
Infections and infestations
Urinary tract infection
|
28.6%
36/126 • Number of events 70 • 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).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
15/126 • Number of events 19 • 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).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
11/126 • Number of events 11 • 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).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.6%
7/126 • Number of events 7 • 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).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
11/126 • Number of events 12 • 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).
|
|
Injury, poisoning and procedural complications
Fall
|
6.3%
8/126 • Number of events 12 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place