Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study

Keywords

Overactive Bladder Fecal Incontinence Non-obstructive Urinary Retention Urinary Bladder, Overactive Urinary Retention InterStim Micro

Eligibility

For people ages 18 years and up

Overactive Bladder Cohort

Inclusion Criteria:

  1. 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
  2. Subjects 18 years of age or older
  3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
  4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
  5. Willing and able to provide signed and dated informed consent

Exclusion Criteria:

  1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
  2. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
  3. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
  4. Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
  5. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
  6. Women who are pregnant or planning to become pregnant
  7. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  8. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Fecal Incontinence Cohort

Inclusion Criteria:

  1. 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)
  2. Subjects 18 years of age or older
  3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
  4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
  5. Willing and able to provide signed and dated informed consent

Exclusion Criteria:

  1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
  2. Uncorrected high grade internal rectal prolapse
  3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
  4. Women who are pregnant or planning to become pregnant
  5. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  6. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Non-Obstructive Urinary Retention Cohort

Inclusion Criteria:

  1. 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
  2. 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.
  3. Subjects 18 years of age or older
  4. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
  5. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
  6. Willing and able to provide signed and dated informed consent

Exclusion Criteria:

  1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
  2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
  3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy .
  4. Women who are pregnant or planning to become pregnant
  5. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
  6. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedtronicNeuro
ID
NCT04506866
Study Type
Interventional
Last Updated