Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
NCT ID: NCT02348112
Last Updated: 2023-12-04
Study Results
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View full resultsBasic Information
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COMPLETED
416 participants
OBSERVATIONAL
2015-01-31
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Altis arm
Subjects will have an Altis sling placed to treat stress urinary incontinence.
Altis Single Incision Sling
Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.
Comparator arm
Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Transobturator or Retropubic Sling
Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.
Interventions
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Altis Single Incision Sling
Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.
Transobturator or Retropubic Sling
Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.
Eligibility Criteria
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Inclusion Criteria
* The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
* The subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics.
* The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc.) for \> 6 months.
Exclusion Criteria
* The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.
* The subject is having a concomitant pelvic floor procedure.
* The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
* The subject had a prior surgical stress urinary incontinence (SUI) treatment.
* The subject has undergone radiation or brachy therapy to treat pelvic cancer.
* The subject has urge predominant incontinence by MESA assessment.
* The subject has an atonic bladder or post void residual (PVR) above 100 cc on ≥ 2 occasions.
* The subject is pregnant and/or is planning to get pregnant in the future.
* The subject has a contraindication to the surgical procedure or the product Instructions for Use (IFU).
* The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.
18 Years
FEMALE
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Ty Erickson, MD
Role: PRINCIPAL_INVESTIGATOR
Rosemark WomenCare Specialists
Locations
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Stanford University
Stanford, California, United States
Pelvic Solutions Center
Denver, Colorado, United States
Urology Specialists, LLC
Hialeah, Florida, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Boston Urogynecology Associates
Cambridge, Massachusetts, United States
Baystate Health System
Springfield, Massachusetts, United States
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, United States
Adult and Pediatric Urology & Urogynecology
Omaha, Nebraska, United States
University of Nevada
Las Vegas, Nevada, United States
Albany Medical Center
Albany, New York, United States
Associated Urologists of North Carolina
Cary, North Carolina, United States
Novant Health
Charlotte, North Carolina, United States
Carolina Urology Partners
Gastonia, North Carolina, United States
FirstHealth Urogynecology
Hamlet, North Carolina, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Akron Urogynecology Associates
Akron, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Genesis Healthcare
Zanesville, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, United States
Institute of Female Pelvic Medicine & Reconstructive Surgery
North Wales, Pennsylvania, United States
Lexington Urology
West Columbia, South Carolina, United States
Sanford Health
Sioux Falls, South Dakota, United States
The Group for Women
Virginia Beach, Virginia, United States
CHUS Hopital Fleurimont
Sherbrooke, Quebec, Canada
Countries
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References
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Erickson T, Gheiler E, Hanson CE, McCrery R, Parekh M, Parva M, Tu LM. Patient Satisfaction and QoL in SUI: Results With Single-Incision or Full-Length Slings. Urogynecology (Phila). 2025 Oct 1;31(10):942-951. doi: 10.1097/SPV.0000000000001586.
Erickson T, Roovers JP, Gheiler E, Parekh M, Parva M, Hanson C, McCrery R, Tu LM. A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence. J Minim Invasive Gynecol. 2021 Jan;28(1):93-99. doi: 10.1016/j.jmig.2020.04.014. Epub 2020 Apr 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SU020
Identifier Type: -
Identifier Source: org_study_id