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Actively Recruiting
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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
20-000813
Category
Urology
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood