Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

Medtronic

Status: Completed

Conditions: Overactive Bladder

Treatments: Device: Medtronic Implantable Tibial Neuromodulation (TNM) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04873271

MDT20033

Details and patient eligibility

About

This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.

Full description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Primary Inclusion Criteria:

1. Subjects 18 years of age or older
2. Have a diagnosis for at least 6 months of OAB
3. No OAB pharmacotherapy for 2 weeks prior to the baseline voiding diary
4. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system and comply with the study protocol
5. Willing and able to provide signed and dated informed consent

Primary Exclusion Criteria:

1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
2. Severe uncontrolled diabetes
3. History of urinary retention within the previous 6 months
4. Current symptomatic urinary tract infection
5. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
6. Current urinary tract mechanical obstruction
7. Have knowledge of planned magnetic resonance imaging (MRIs) or diathermy
8. History of a prior implantable tibial neuromodulation system
9. Skin lesions or compromised skin integrity at the implant site
10. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
11. Previous pelvic floor surgery in the last 6 months
12. Women who are pregnant or planning to become pregnant
13. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
14. Any subject who is considered to be part of a vulnerable patient population.
15. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.** **Subjects in concurrent studies can only be enrolled with permission from Medtronic.

Contact Medtronic's study manager to determine if the subject can be enrolled in both studies.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)