Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT04506866
Eligibility Criteria:
Overactive Bladder Cohort
Inclusion Criteria:
1. 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
2. Subjects 18 years of age or older
3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
5. Willing and able to provide signed and dated informed consent
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
Inclusion Criteria:
1. 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)
2. Subjects 18 years of age or older
3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
5. Willing and able to provide signed and dated informed consent
Exclusion Criteria:
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
Inclusion Criteria:
1. 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
2. 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.
3. Subjects 18 years of age or older
4. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
5. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
6. Willing and able to provide signed and dated informed consent
Exclusion Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04506866
Study Brief:
Protocol Section:
NCT04506866