Standardization of Lead Placement for Sacral Neuromodulation. Part 1

Exclusion Criteria

• •1. Current of prior evidence of primary stress incontinence or mixed incontinence where the stress component overrides the urgency component
• •2. Any neurological condition that may interfere with normal bladder function, including stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
• •3. Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH)
• •4. Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or surgery in past 12 months
• •5. Unable to toilet self and have and maintain good personal hygiene
• •6. Unable to provide clear, thoughtful responses to questions and questionnaires
• •7. Urinary tract, bladder or vaginal infection or inflammation
• •8. Hematuria, and absence of an elaborate diagnostic work-up
• •9. Severe or uncontrolled diabetes (A1C \> 8, documented in the last 3 months) or diabetes with peripheral nerve involvement
• •10. Allergy to local anesthetic or adhesives
• •11. Bleeding disorder or on an anticoagulant that cannot be stopped for 3 days before the implant
• •12. Pregnant, lactating, planning to become pregnant, given birth in the past 12 months, or female of child-bearing potential and not practicing a medically-approved method of birth control
• •13. Skin lesions or compromised skin at the implant or stimulation site
• •14. Use of investigational drug or device therapy or participation in any study involving or impacting gynecologic, urinary or renal function within past 4 weeks
• •15. Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site
• •16. Knowledge of planned MRIs, diathermy, or high output ultrasonic exposure
• •17. Presence of a documented condition or abnormality that could compromise the safety of the patient
• •18. Any psychiatric or personality disorder at the discretion of the study physician
• •19. Interstitial cystitis or bladder pain syndrome as defined by the EAU guidelines
• •20. Life expectancy of less than 1 year