Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

NCT04873271 | Completed FDA Device

• 1 other identifier: MDT20033
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Medtronic Implantable Tibial Neuromodulation (TNM) System DEVICE

Tibial neuromodulation (TNM) devices are implantable devices that provide stimulation to the tibial nerve.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
• Severe uncontrolled diabetes
• History of urinary retention within the previous 6 months
• Current symptomatic urinary tract infection
• Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
• Current urinary tract mechanical obstruction
• Have knowledge of planned magnetic resonance imaging (MRIs) or diathermy
• History of a prior implantable tibial neuromodulation system
• Skin lesions or compromised skin integrity at the implant site
• Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
• Previous pelvic floor surgery in the last 6 months
• Women who are pregnant or planning to become pregnant
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
• Any subject who is considered to be part of a vulnerable patient population.
• 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.

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (7)

Georgia Urology

Marietta, Georgia, 30060, United States

Location

Urologic Research and Consulting

Englewood, New Jersey, 07631, United States

Location

FirstHealth Urogynecology

Hamlet, North Carolina, 28345, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57105, United States

Location

Urology Partners of North Texas

Arlington, Texas, 76015, United States

Location

Milwaukee Urogynecology Ascension Medical Group

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Neoplasm Staging; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prognosis; Diagnosis; Drug Therapy; Therapeutics

Study Officials

• Anne Miller

  Medtronic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 5, 2021
• Study Start: May 11, 2021
• Primary Completion: August 4, 2021
• Study Completion: July 8, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)