InterStim® Amplitude Study

Launched by MEDTRONICNEURO · Nov 3, 2017

Keywords

ClinConnect Summary

This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes
• • 2. Female subjects 18 years of age or older
• • 3. Candidate for InterStim Lead Placement
• • 4. Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study)
• • 5. Willing and able to provide signed and dated informed consent
• • 6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication
• Exclusion Criteria:
• • 1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
• • 2. History of diabetes unless the diabetes is well-controlled through diet and/or medications
• • 3. Symptomatic urinary tract infection (UTI)
• • 4. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
• • 5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
• • 6. Implanted with a neurostimulator, pacemaker, or defibrillator
• • 7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy
• • 8. Women who are pregnant or planning to become pregnant
• • 9. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
• • 10. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee).