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InterStim Micro Post Market Clinical Follow-up Study

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Overactive Bladder Cohort

Inclusion Criteria:

  • Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with greater than or equal to 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
  • 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)
  • Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
  • Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
  • Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
  • 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. Fecal Incontinence Cohort

Inclusion Criteria:

  • Have a diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate or severe soiling)
  • 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)
  • Uncorrected high grade internal rectal prolapse
  • 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. Non-Obstructive Urinary Retention Cohort

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.

Join this Trial

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Study Stats
Protocol No.
20-000813
Category
Urology
Contact
JASMYN AKANINWOR
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04506866
For detailed technical eligibility, visit ClinicalTrials.gov.