Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

Evaluation of Implantable Tibial Neuromodulation Pivotal Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05226286

Acronym

TITAN 2

Enrollment

188

Registered

2022-02-07

Start date

2022-01-31

Completion date

2025-05-30

Last updated

2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Brief summary

The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.

Interventions

DEVICEMedtronic Implantable Tibial Neuromodulation (TNM) System

Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subjects 18 years of age or older 2. Qualifying voiding diary 3. Have a diagnosis of UUI for at least 6 months 4. Failed and/or are not a candidate for conservative therapies. 5. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol 6. Willing and able to provide signed and dated informed consent

Exclusion criteria

1. Have primary stress incontinence 2. History of a prior implantable tibial neuromodulation system 3. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device 4. Previous pelvic floor surgery in the last 6 months 5. Women who are pregnant or planning to become pregnant during the course of the study 6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Design outcomes

Primary

Measure	Time frame	Description
UUI Responder	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.

Secondary

Measure	Time frame	Description
UUI Change From Baseline	6 months	Change in UUI episodes at 6 months compared to baseline in subjects with UUI at baseline.
UF Change From Baseline	6 months	Change in daily UF episodes at 6 months compared to baseline in subjects with UF at baseline.
UPS Change at 6 Months	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).
OAB-q Change From Baseline	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.

Countries

United States

Participant flow

Recruitment details

Eligible subjects who signed the study-specific informed consent form (ICF) were considered enrolled in the study.

Participants by arm

Arm	Count
Implanted Subjects Includes subjects who were implanted	126
Total	126

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Death	1
Overall Study	Device explant with no planned replacement	1
Overall Study	Lost to Follow-up	3
Overall Study	Physician Decision	1
Overall Study	Planned surgery with an implanted metal material closer than allowed in research protocol	1
Overall Study	Screen failures prior to implant	62
Overall Study	Transitioned to urethral catheter/suprapubic tube	1
Overall Study	Withdrawal by Subject	13

Baseline characteristics

Characteristic	Implanted Subjects
Age, Continuous	62.6 years STANDARD_DEVIATION 13.68
BMI	34.8 kg/m2 STANDARD_DEVIATION 8.61
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	16 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	108 Participants
Region of Enrollment United States	126 participants
Sex: Female, Male Female	120 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 126
other Total, other adverse events	81 / 126
serious Total, serious adverse events	35 / 126

Outcome results

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.

Time frame: 6 months