InterStim Micro Post Market Clinical Follow-up Study

Overactive Bladder Cohort

• 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

• 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

• 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

• 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

• 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

• 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.