The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence

In brief

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).

Key facts

Study ID

NCT01272284

Run by

Coloplast A/S

People needed

113

Starts

2010-12-01

Expected to finish

2014-01-01

Last updated by the study team

2021-02-11

Who can join

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

You may qualify if…

• Subject is female at least 18 years of age
• Subject is able and willing to complete all procedures and follow-up visits indicated in this protocol
• 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…

• Subject has an active urogenital infection or active skin infection in region of surgery
• Subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading
• Subject is having a concomitant pelvic floor procedure
• 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)
• Subject had a prior surgical SUI treatment
• Subject has undergone radiation or brachy therapy to treat pelvic cancer
• Subject has urge predominant incontinence
• Subject has an atonic bladder or a post void residual (PVR) consistently about 100cc
• Subject is pregnant and/or is planning to get pregnant in the future
• Subject has a contraindication to the surgical procedure or the Altis Instructions For Use (IFU)
• Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsor's approval

Where it is running

• Tri Valley Urology — Murrieta, California, United States
• Urology Specialists, LLC — Hialeah, Florida, United States
• Atlanta Medial Research Institute — Alpharetta, Georgia, United States
• Rosemark Womencare Specialist — Idaho Falls, Idaho, United States
• University of Illinois at Chicago - Department of Urology — Chicago, Illinois, United States
• Illinois Urogynecology, LTD — Oak Lawn, Illinois, United States
• Female Pelvic Medicine & Urogynecology Institute of Michigan — Grand Rapids, Michigan, United States
• Bellevue ObGyn — Bellevue, Nebraska, United States
• Delaware Valley Urology — Voorhees Township, New Jersey, United States
• Carolina Urology Partners — Gastonia, North Carolina, United States
• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Greenville Hospital System — Greenville, South Carolina, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• The Group for Women — Norfolk, Virginia, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Johnston Willis Medical Center — Richmond, Virginia, United States
• CHUS Hopital Fleurimont — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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