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Neuromodulation Device
InterStim Micro for Overactive Bladder (ELITE Trial)
N/A
Waitlist Available
Research Sponsored by MedtronicNeuro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
ELITE Trial Summary
This trial will assess the long-term safety and performance of a device used to treat urinary incontinence.
Who is the study for?
This trial is for adults who need sacral neuromodulation therapy, can complete study tasks, and have specific diagnoses of bowel incontinence or overactive bladder as shown by diaries. Pregnant women, those with certain neurological conditions, mechanical urinary obstructions, or recent botulinum toxin therapy are excluded.Check my eligibility
What is being tested?
The InterStim Micro System's safety and performance for treating urinary retention, bowel incontinence, and overactive bladder are being studied. This post-market follow-up aims to confirm the long-term outcomes of this treatment.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include discomfort at the implant site, potential nerve injury from device placement or stimulation-related issues such as pain or changes in bowel/bladder function.
ELITE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline for HRQL Total Score
Change From Baseline in CCIS Score
Change From Baseline in the Number of CISC/Day
ELITE Trial Design
3Treatment groups
Experimental Treatment
Group I: Overactive Bladder CohortExperimental Treatment1 Intervention
Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.
Group II: Non-Obstructive Urinary Retention CohortExperimental Treatment1 Intervention
Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
Group III: Fecal Incontinence CohortExperimental Treatment1 Intervention
Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.
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Who is running the clinical trial?
MedtronicNeuroLead Sponsor
69 Previous Clinical Trials
20,671 Total Patients Enrolled
4 Trials studying Urinary Retention
923 Patients Enrolled for Urinary Retention
Mylène ChampsStudy DirectorMedtronic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received treatment with shortwave diathermy, microwave diathermy, or therapeutic diathermy.You have a serious problem with your rectum that has not been fixed.You have a condition where you cannot empty your bladder properly, and you need to use a catheter at least 5 times a day.You have been diagnosed with overactive bladder by showing frequent urgent need to urinate or urinary urge incontinence.You are being considered for a specific type of nerve therapy called sacral neuromodulation using the InterStim Micro System.You have a condition called fecal incontinence as shown by keeping a diary for a week and having two or more episodes of uncontrolled bowel movements with soiling.You have had trouble emptying your bladder for at least six months, and it has been measured as too full on two different occasions.You have certain neurological conditions like multiple sclerosis or significant nerve damage.You have uncontrollable urine leakage when you cough, sneeze, or laugh.You have a blockage in your urinary tract, like from an enlarged prostate or a narrow urethra.You have received botulinum toxin therapy for urinary symptoms in the last 12 months.
Research Study Groups:
This trial has the following groups:- Group 1: Overactive Bladder Cohort
- Group 2: Fecal Incontinence Cohort
- Group 3: Non-Obstructive Urinary Retention Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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