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Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)

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Medtronic

Status

Active, not recruiting

Conditions

Overactive Bladder

Treatments

Device: Medtronic Implantable Tibial Neuromodulation (TNM) System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05226286
MDT20061

Details and patient eligibility

About

The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.

Enrollment

188 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Subjects 18 years of age or older
  2. Qualifying voiding diary
  3. Have a diagnosis of UUI for at least 6 months
  4. Failed and/or are not a candidate for conservative therapies.
  5. Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol
  6. Willing and able to provide signed and dated informed consent

Exclusion criteria

  1. Have primary stress incontinence
  2. History of a prior implantable tibial neuromodulation system
  3. Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device
  4. Previous pelvic floor surgery in the last 6 months
  5. Women who are pregnant or planning to become pregnant during the course of the study
  6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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