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Clinical Trials/NL-OMON56302
NL-OMON56302RecruitingNot Applicable

A Prospective, Randomized Clinical Trial Evaluating INTIBIA (TM), an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months - INTIBIA Pivotal Study

Coloplast Corp.0 sites36 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
36
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1. Women or men 22-80 years of age
  • •2. Symptoms of overactive bladder with urgency urinary incontinence (UUI)
  • •demonstrated on a 72-hour voiding diary defined as a minimum of four (4)
  • •leaking episodes associated with urgency, and at least one leaking episode each
  • •24-hour period
  • •3. Greater than or equal to 6-month history of UUI diagnosis
  • •4. Failure of conservative or behavioral therapy (e.g., bladder diet, timed
  • •voiding, bladder training, bladder control strategies, pelvic floor muscle
  • •training, fluid management)
  • •5. Willing to abstain from OAB medications for the duration of the study
  • •6. Willing to maintain a stable dose of all other medications that affect
  • •bladder function (e.g., tricyclic antidepressants) for at least four (4) weeks
  • •prior to beginning the baseline voiding diary and baseline questionnaires
  • •7. Ambulatory and able to use the toilet independently and without difficulty
  • •8. Willing and capable of providing informed consent
  • •9. Willing and able to complete all procedures and follow-up visits indicated
  • •in the protocol

Exclusion Criteria

  • •1. Diagnosis of stress urinary incontinence or mixed urinary incontinence, as
  • •confirmed by cough stress test and with a response of Yes to Q3 on the UDI-6
  • •questionnaire
  • •2. Current symptomatic urinary tract infection (UTI), urethritis, or more than
  • •three (3) UTIs in past year
  • •3. Have post-void residual urine volume >30% of total voided volume
  • •4. Inadequate skin integrity or any evidence of an infection, edema or
  • •inflammation in either lower leg
  • •5. Evidence of anatomic abnormalities that could jeopardize the placement of
  • •the device or pose a hazard to the subject
  • •6. Prior treatment of urinary symptoms with nerve stimulation (e.g.,
  • •percutaneous tibial nerve stimulation [PTNS] or sacral nerve stimulation [SNS])
  • •7. History of chronic pain (e.g., chronic pelvic pain, fibromyalgia, Lyme
  • •disease, chronic back pain)
  • •8. An active implantable electronic device regardless of whether stimulation is
  • •9. Treatment of urinary symptoms with botulinum toxin therapy within twelve
  • •(12) months
  • •Anyneurologicalconditionthatcouldinterferewithnormalbladderortibialnervefunction
  • •,including stroke, epilepsy, multiple sclerosis, Parkinson*s disease,
  • •peripheral neuropathy, fibromyalgia, or spinal cord injury (e.g., paraplegia)
  • •11. Current urinary tract mechanical obstruction (e.g.,benign prostatic
  • •enlargement or urethral stricture)
  • •12. Other urinary tract dysfunction (e.g.,abnormal upper urinary tract
  • •function, vesicoureteral reflux, bladder stone or tumor, urinary fistula)
  • •13. Endstage renal failure,GFR<35, or dialysis
  • •14. History of pelvic cancer within the past two years
  • •15. Pelvic organ prolapse at or beyond the hymenal ring
  • •InterstitialcystitisorbladderpainsyndromeasdefinedbyeitherAmericanUrologicalAsso
  • •ciation (AUA) or European Association of Urology (EAU) guidelines prior to
  • •INTIBIA implant date
  • •17. Diabetes with peripheral nerve compromise or uncontrolled diabetes
  • •18. Pregnant as confirmed by urine or serum pregnancy test, plans to become
  • •pregnant over the study period, is less than one-year post-partum, is
  • •breast-feeding
  • •19. Current active or a chronic systemic infection
  • •20. Condition requiring magnetic resonance imaging(MRI) of lower leg
  • •21. Condition requiring diathermy
  • •22. Allergy to polyethylene terephthalate, silicone rubber, platinum, iridium,
  • •or polyurethane
  • •23. Allergy to local anesthetic or adhesives
  • •Deemedunsuitableforenrollmentbytheinvestigatorbasedonhistoryorphysicalexaminatio
  • •n(e.g., bleeding disorders, current anticoagulant medications)
  • •25. Enrolled in another investigational or interventional device or drug trial
  • •over the study period

Investigators

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