Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Overactive Bladder Cohort
Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.
  • Device: InterStim Micro
    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
Other
Fecal Incontinence Cohort
Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.
  • Device: InterStim Micro
    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
Other
Non-Obstructive Urinary Retention Cohort
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
    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

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Jerome Yaklic, MD

More Details

Status
Recruiting
Sponsor
MedtronicNeuro

Study Contact

Mylène Champs
763-526-1627
mylene.champs@medtronic.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.