InterStim Micro Post Market Clinical Follow-up Study

Study Overview
=================
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.

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

Conditions
-----------------
Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention

Intervention / Treatment
-----------------
* Device: InterStim Micro


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Overactive Bladder Cohort<br>Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms. | Device: InterStim Micro<br>* Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use<br>|
| Other: Fecal Incontinence Cohort<br>Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms. | Device: InterStim Micro<br>* Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use<br>|
| Other: Non-Obstructive Urinary Retention Cohort<br>Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms. | Device: InterStim Micro<br>* Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive Bladder Cohort | To demonstrate an improvement in Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) total score at 3 months post-implant compared to baseline | 3 months | 
| Fecal Incontinence Cohort | To demonstrate an improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline | 3 months | 
| Non-Obstructive Urinary Retention Cohort | To demonstrate an improvement in number of clean intermittent self-catheterizations (CISC) per day at 3 months post-implant compared to baseline | 3 months |