Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

Not Applicable

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT04873271
• Lead Sponsor: MedtronicNeuro

Brief Summary

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

Detailed 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.)

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-05
• Study Start: 2021-05-11
• Primary Completion: 2021-08-04
• Status Verified: 2022-07
• Study Completion: 2022-07-08
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To characterize the TNM device implant procedure	14 days	This information will be collected through a series of questions for participating investigators via a case report form at implant through the 14-day follow-up visit.
To characterize the TNM device initial system use	14 days	This information will be collected through programming and device data at implant through the 14-day follow-up visit.

Trial Locations

Locations (7)

Urologic Research and Consulting; 🇺🇸 Englewood, New Jersey, United States

Prisma Health; 🇺🇸 Greenville, South Carolina, United States

Sanford Health; 🇺🇸 Sioux Falls, South Dakota, United States

FirstHealth Urogynecology; 🇺🇸 Hamlet, North Carolina, United States

Georgia Urology; 🇺🇸 Marietta, Georgia, United States

Urology Partners of North Texas; 🇺🇸 Arlington, Texas, United States

Milwaukee Urogynecology Ascension Medical Group; 🇺🇸 Milwaukee, Wisconsin, United States