Study to Evaluate Implantable Tibial Neuromodulation

Overview

About this study

The purpose of this study is to assess the safety and effectiveness of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system by demonstrating that the percentage of subjects considered a UUI responder after 6 months of tibial neuromodulation exceeds a performance goal of 40%.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

 Inclusion Criteria:

  • Subjects 18 years of age or older.
  • A 3-day voiding diary demonstrating a minimum of 3 episodes of urinary urge incontinence in 72 hours.
  • Have a diagnosis of UUI for at least 6 months.
  • No OAB pharmacotherapy for 2 weeks prior to completion of the baseline voiding diary and Overactive Bladder Quality of Life (OAB-q) questionnaire.
  • Failed, or are not a candidate for, conservative non-pharmacologic treatment (e.g., pelvic floor training, biofeedback, behavioral modification)
  • In the opinion of the Investigator, subject has failed and/or is intolerant to at least 1 overactive bladder medication or Investigator has determined that medication use is not appropriate based on the subject’s profile and medical history.
  • 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.

Exclusion Criteria:

  • Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
  • 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 [see enrollment/baseline requirements for use of the Medical, Epidemiological, and Social Aspects of Aging urinary incontinence questionnaire (MESA) questionnaire].
  • Diagnosis of bladder pain syndrome, pelvic pain, or interstitial cystitis.
  • Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
  • History of a prior implantable tibial neuromodulation system.
  • Knowledge of planned diathermy procedures.
  • Have had treatment of urinary symptoms with sacral neuromodulation in the past 6 months, botulinum toxin therapy in the past 9 months or percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) in the past 3 months.
  • Skin lesions or compromised skin integrity (e.g., skin atrophy, thinning, fragility, etc.) which may affect incision healing at the implant site.  Current or a recent history (within the past 6 months) of a medical condition such as venous insufficiency and/or venous stasis ulcers, clinically significant malnutrition, immunocompromised state, or other relevant chronic disease which may indicate a higher risk for delayed or poor wound healing.
  • Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device (including any metal implant that is within 20 cm of the intended neurostimulator location).
  • Previous pelvic floor surgery in the last 6 months.
  • Women who are pregnant or planning to become pregnant during the course of the study.
  • Any subject who is considered to be part of a vulnerable patient population.**
  • Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  • Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.***

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Brian Linder, M.D.

Open for enrollment

Contact information:

Maureen Lemens C.C.R.C.

(507) 293-1487

Lemens.Maureen@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20529190

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