Study Results
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View full resultsBasic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2018-02-27
2019-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Amplitude Setting #1
InterStim Therapy will be set to amplitude parameter #1.
InterStim Therapy
Device Programming
Amplitude Setting #2
InterStim Therapy will be set to amplitude parameter #2.
InterStim Therapy
Device Programming
Amplitude Setting #3
InterStim Therapy will be set to amplitude parameter #3.
InterStim Therapy
Device Programming
Interventions
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InterStim Therapy
Device Programming
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
FEMALE
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Locations
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Academic Urology & Urogynecology of Arizona
Phoenix, Arizona, United States
East Coast Institute for Research
Jacksonville, Florida, United States
Pinellas Urology
St. Petersburg, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Minnesota Urology Fridley
Fridley, Minnesota, United States
Minnesota Urology Woodbury
Woodbury, Minnesota, United States
Adult Pediatric Urology and Urogynecology
Omaha, Nebraska, United States
Urologic Research & Consulting
Englewood, New Jersey, United States
Carolina Urology Partners
Concord, North Carolina, United States
Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System
Chattanooga, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Aurora Research Institute - Aurora West Allis Women's Pavilion
West Allis, Wisconsin, United States
UZ Leuven - Campus Gasthuisberg - Department Urology
Leuven, , Belgium
University Urology Associates, Toronto Western Hospital
Toronto, Ontario, Canada
CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
Rouen, , France
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Erasmus MC
Rotterdam, , Netherlands
University College London Hospitals NHS Foundation Trust - University College Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT17030
Identifier Type: -
Identifier Source: org_study_id
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