Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

Overactive Bladder Clinical Trial

— TITAN 1  

Official title:

Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873271
• Other study ID #: MDT20033
• Status: Completed
• Phase: N/A
• Start date: May 11, 2021
• Est. completion date: July 8, 2022

Study information

• Verified date: July 2022
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 8, 2022
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Device:
• Medtronic Implantable Tibial Neuromodulation (TNM) System
Tibial neuromodulation (TNM) devices are implantable devices that provide stimulation to the tibial nerve.

Locations

Country	Name	City	State
United States	Urology Partners of North Texas	Arlington	Texas
United States	Urologic Research and Consulting	Englewood	New Jersey
United States	Prisma Health	Greenville	South Carolina
United States	FirstHealth Urogynecology	Hamlet	North Carolina
United States	Georgia Urology	Marietta	Georgia
United States	Milwaukee Urogynecology Ascension Medical Group	Milwaukee	Wisconsin
United States	Sanford Health	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the TNM device implant procedure	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.	14 days
Primary	To characterize the TNM device initial system use	This information will be collected through programming and device data at implant through the 14-day follow-up visit.	14 days