Study Results
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View full resultsBasic Information
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COMPLETED
272 participants
OBSERVATIONAL
2020-11-30
2024-03-31
Brief Summary
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Detailed Description
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The study is expected to complete enrollment in approximately 24 months and follow the patients per protocol for 1 year. The study was conducted at approximately 30 centers in the United States and Canada.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Willing and capable of providing informed consent
3. Capable of participating in all testing associated with this clinical investigation
Exclusion Criteria
1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
2. Any psychiatric or personality disorder at the discretion of the study physician
3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
4. A female who is breastfeeding
5. A female with a positive urine pregnancy test
For OAB \& UR:
6. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
7. Current symptomatic urinary tract infection (UTI)
For FI only:
8. Rectomucosal prolapse or congenital anorectal malformation
18 Years
ALL
No
Sponsors
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Axonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Noblett, MD
Role: STUDY_DIRECTOR
Axonics, Inc.
Locations
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Arkansas Urology Research Center
Little Rock, Arkansas, United States
University of California, Irvine
Irvine, California, United States
Stanford Medicine
Redwood City, California, United States
Sansum Clinic Urology
Santa Barbara, California, United States
Manatee Medical Research Institute
Bradenton, Florida, United States
Urologic Solutions
Fort Myers, Florida, United States
Florida Urology Partners
North Redington Beach, Florida, United States
Pinellas Urology
St. Petersburg, Florida, United States
Florida Urology Partners
Tampa, Florida, United States
Northwestern
Chicago, Illinois, United States
LSU Health
New Orleans, Louisiana, United States
Ochsner Health
New Orleans, Louisiana, United States
Chesapeake Urology
Hanover, Maryland, United States
Comprehensive Urology
Royal Oak, Michigan, United States
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, United States
The Urology Center PC
Omaha, Nebraska, United States
New Jersey Urology
Englewood, New Jersey, United States
Stony Brook University
Stony Brook, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Urologic Specialists Oklahoma
Tulsa, Oklahoma, United States
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States
Penn State University
Hershey, Pennsylvania, United States
The Female Pelvic Health Center
Newtown, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Southern Urogynecology
West Columbia, South Carolina, United States
Center for Pelvic Health
Franklin, Tennessee, United States
University of Alberta
Edmonton, Alberta, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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105-0076
Identifier Type: -
Identifier Source: org_study_id
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