InterStim Micro Post Market Clinical Follow-up Study (ELITE)

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
• •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
• •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.