Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Completed

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT02348112

Run by

Coloplast A/S

People needed

416

Starts

2015-01-01

Expected to finish

2021-09-01

Last updated by the study team

2023-12-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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