InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention
About this trial
This is an interventional treatment trial for Overactive Bladder
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.
Sites / Locations
- East Coast Institute for Research
- Florida Urology Partners
- First Urology
- Saint Elizabeth Healthcare
- University of Louisville Hospital
- Louisiana State University Health Sciences Center New Orleans
- Ochsner Medical Center
- Minnesota Urology (Woodbury)
- Montefiore Medical Center
- The Christ Hospital
- University of Pennsylvania
- Prisma Health
- Colon Surgeons of Charleston
- Vanderbilt University Medical Center
- Urology Partners of North Texas
- University of Texas Medical Branch
- West Virginia University
- University Urology Associates
- CHU de Nantes - Hôtel Dieu
- Centre Hospitalier Universitaire De Rennes
- Maastricht Universitair Medisch Centrum (MUMC)
- Kantonsspital St.Gallen
- Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital
- The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Overactive Bladder Cohort
Fecal Incontinence Cohort
Non-Obstructive Urinary Retention Cohort
Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.
Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.
Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.