InterStim® Sacral Nerve Modulation Cycling Study

Exclusion Criteria

• •11. History of Multiple sclerosis
• •12. History of Reiter's syndrome
• •13. History of spinal cord injury or a cerebral vascular accident (CVA)
• •14. History of diabetes unless the diabetes is well-controlled through diet and/or medications
• •15. Active symptomatic urinary tract infection (UTI)
• •16. Stress incontinence as the primary diagnosis
• •17. Urgency frequency as a primary diagnosis
• •18. Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary diagnosis
• •19. Interstitial cystitis as the primary diagnosis
• •20. Urinary retention as the primary diagnosis
• •21. Treatment of urinary symptoms with botulinum toxin in the past 12 months or any plan to have botulinum toxin treatment during the study
• •22. Bilateral lead placement
• •23. Have other implantable neurostimulator, pacemaker, or defibrillator
• •24. Have knowledge of planned diathermy, microwave exposure, high output ultrasonic exposure, RF energy exposure, or MRI scans not included within the scanning conditions provided within the MRI Guidelines for InterStim Therapy neurostimulation systems.
• •25. Have an anticipated system modification within the next 5 months
• •26. Women who are pregnant or planning to become pregnant (women of child-bearing potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to randomization visit)
• •27. Subjects who frequently use the patient programmer to change device program settings ("frequently" is defined as at least once a day and does not include shutting off the device for safety purposes)
• •28. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol.
• •29. Study site personnel will contact the Medtronic Study Manager (or designee) to determine if a potential subject who plans to enroll in an investigational device or drug trial, or is currently enrolled in an investigational device or drug trial is eligible for this study