ELITE study v2.0
Research type
Research Study
Full title
Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes”
IRAS ID
277285
Contact name
Victoria Lavin
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The purpose of this study is to confirm long-term safety and performance of the InterStim Micro System for sacral neuromodulation.
When the communication between the nerves, brain, bladder, and muscles that control the passage of urine and stools are not working correctly, they become overactive resulting in increased, reduced or uncontrolled bladder and bowel movements.
Symptoms of overactive bladder include an increased urge to urinate which may lead to unconscious leakage of urine and/or a frequent urination, symptoms of faecal incontinence include the inability to control bowel movements and symptoms for non-obstructive urinary retention include the inability to urinate.
Sacral neuromodulation, using the InterStim Micro System, is a device implanted under the skin that sends small electrical pulses through a lead to the sacral nerves, which are involved in bladder and bowel control.
The primary objective in the overactive bladder group is to show an improvement in patient quality of life, assessed by questionnaires (OAB-q Questionnaire Health Related Quality of Life (HRQL). The primary objective for the faecal incontinence group is to show an improvement in patient quality of life, assessed by Cleveland Clinic Incontinence Score (CCIS). The primary objective for non-obstructive urinary retention group is to show an improvement in patient quality of life, assessed by the number of clean intermittent self-catheterizations (CISC) per day. The primary objectives of the study will evaluate data gathered at 3 months post-implant procedure.
A minimum of 50 subjects are required to complete the 3-month follow up visit in the overactive bladder and faecal incontinence groups, whilst a minimum of 30 subjects are required in the non-obstructive urinary retention group. The study will be conducted at around 40 hospitals across Europe, Canada, Australia and The United States of America.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0052
Date of REC Opinion
12 Feb 2020
REC opinion
Favourable Opinion