InterStim Micro Post Market Clinical Follow-up Study

  • STATUS
    Recruiting
  • End date
    Apr 26, 2024
  • participants needed
    160
  • sponsor
    MedtronicNeuro
Updated on 26 June 2021
Investigator
Mylène Champs
Primary Contact
University of Louisville Hospital (6.1 mi away) Contact
+27 other location
incontinence
neuromodulation

Summary

Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.

Details
Condition Rectal disorder, bladder disorder, Fecal Incontinence, Overactive Bladder, Rectal Disorders, Non Obstructive Urinary Retention, Bladder Disorders, bowel incontinence
Treatment InterStim Micro
Clinical Study IdentifierNCT04506866
SponsorMedtronicNeuro
Last Modified on26 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a diagnosis of non-obstructive urinary retention as demonstrated by a 7-day urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations
Chronic non-obstructive urinary retention with an elevated post-void residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions
Subjects 18 years of age or older
Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging 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)
Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
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
Concurrent participation in another clinical study that may add additional safety risks and/or confound study results
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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