Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence
1 other identifier
observational
416
2 countries
27
Brief Summary
The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 16, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedResults Posted
Study results publicly available
November 21, 2023
CompletedDecember 4, 2023
November 1, 2023
6.7 years
January 16, 2015
February 20, 2023
November 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Effectiveness Endpoint
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.
6 months
Primary Safety Endpoint
Observed device and/or procedure-related serious adverse events through 36 months.
36 months
Study Arms (2)
Altis arm
Subjects will have an Altis sling placed to treat stress urinary incontinence.
Comparator arm
Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Interventions
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.
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
Participants will be selected from urology or urogynecology specialties.
You may qualify if:
- The subject is female and at least 18 years of age.
- 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.
You may not qualify if:
- The subject has an active urogenital infection or active skin infection in region of surgery.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (27)
Stanford University
Stanford, California, 94305, United States
Pelvic Solutions Center
Denver, Colorado, 80218, United States
Urology Specialists, LLC
Hialeah, Florida, 33016, United States
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404, United States
Women's Health Advantage
Fort Wayne, Indiana, 46825, United States
Boston Urogynecology Associates
Cambridge, Massachusetts, 02138, United States
Baystate Health System
Springfield, Massachusetts, 01199, United States
Female Pelvic Medicine & Urogynecology
Grand Rapids, Michigan, 49503, United States
Adult and Pediatric Urology & Urogynecology
Omaha, Nebraska, 68114, United States
University of Nevada
Las Vegas, Nevada, 89102, United States
Albany Medical Center
Albany, New York, 12208, United States
Associated Urologists of North Carolina
Cary, North Carolina, 27511, United States
Novant Health
Charlotte, North Carolina, 28210, United States
Carolina Urology Partners
Gastonia, North Carolina, 28054, United States
FirstHealth Urogynecology
Hamlet, North Carolina, 28345, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Akron Urogynecology Associates
Akron, Ohio, 44313, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Genesis Healthcare
Zanesville, Ohio, 43701, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103, United States
Institute of Female Pelvic Medicine & Reconstructive Surgery
North Wales, Pennsylvania, 19454, United States
Lexington Urology
West Columbia, South Carolina, 29169, United States
Sanford Health
Sioux Falls, South Dakota, 57105, United States
The Group for Women
Virginia Beach, Virginia, 23456, United States
CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Related Publications (2)
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.
PMID: 39423154DERIVEDErickson 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.
PMID: 32320798DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The strengths of the Altis 522 Study include its large sample size, prospective, multicenter design and use of a wide variety of standardized and validated instruments to collect patient reported outcomes over a 36-month study duration. Potential limitations associated with the study include rates of enrollment, subject attrition rates, and differences in baseline characteristics.
Results Point of Contact
- Title
- Liz Driessen
- Organization
- Coloplast Corp.
Study Officials
- PRINCIPAL INVESTIGATOR
Ty Erickson, MD
Rosemark WomenCare Specialists
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2015
First Posted
January 28, 2015
Study Start
January 1, 2015
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
December 4, 2023
Results First Posted
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share