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Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

Sponsor
MedtronicNeuro (Industry)
Overall Status
Completed
CT.gov ID
NCT04873271
Collaborator
(none)
24
Enrollment
7
Locations
13.9
Actual Duration (Months)
3.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Medtronic Implantable Tibial Neuromodulation (TNM) System
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study
Actual Study Start Date :
May 11, 2021
Actual Primary Completion Date :
Aug 4, 2021
Actual Study Completion Date :
Jul 8, 2022

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Georgia Urology Marietta Georgia United States 30060
2 Urologic Research and Consulting Englewood New Jersey United States 07631
3 FirstHealth Urogynecology Hamlet North Carolina United States 28345
4 Prisma Health Greenville South Carolina United States 29605
5 Sanford Health Sioux Falls South Dakota United States 57105
6 Urology Partners of North Texas Arlington Texas United States 76015
7 Milwaukee Urogynecology Ascension Medical Group Milwaukee Wisconsin United States 53211

Sponsors and Collaborators

  • MedtronicNeuro

Investigators

  • Study Director: Anne Miller, Medtronic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT04873271
Other Study ID Numbers:
  • MDT20033
First Posted:
May 5, 2021
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Urinary Bladder, Overactive

Study Results

No Results Posted as of Jul 13, 2022