Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence



Status:Recruiting
Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:1/20/2018
Start Date:January 2015
End Date:January 2020
Contact:Kris Veltum
Email:uskve@coloplast.com
Phone:763-248-5744

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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

The aim of this postmarket study is to compare the safety and effectiveness of the Altis
Single Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36
months.

This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS
(n=266) and transobturator and/or retropubic slings (n=133) in the treatment of stress
urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for
a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study
population will consist of adult female subjects with stress incontinence who are clinically
indicated for surgical intervention with a mesh sling.

Inclusion Criteria:

- 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 through cough stress test or
urodynamics.

- The subject has failed two non-invasive incontinence therapies (such as Kegal
exercise, behavior modification, pad use, biofeedback, etc.) for > 6 months.

Exclusion Criteria:

- 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 neurological causes (e.g. multiple sclerosis,
spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter
dyssynergia, Parkinsons disease, or similar conditions).

- The subject had a prior surgical stress urinary incontinence 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 of 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.
We found this trial at
29
sites
Idaho Falls, Idaho 83404
Principal Investigator: Matthew Robison, MD
Phone: 208-557-2924
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Marie Paraiso, MD
Phone: 216-445-2597
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Weston, Florida 33331
Principal Investigator: G. Willy Davila, MD
Phone: 954-659-5888
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Weston, FL
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Akron, Ohio 44313
Principal Investigator: Costas Apostolis, MD
Phone: 330-344-7681
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Albany, New York 12208
Principal Investigator: David Kimble, MD
Phone: 518-264-6001
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Albany, NY
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Allentown, Pennsylvania 18105
Principal Investigator: Vincent Lucente, MD
Phone: 610-435-9575
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Cambridge, Massachusetts 02138
Principal Investigator: Peter Rosenblatt, MD
Phone: 617-354-5452
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Cambridge, MA
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Cary, North Carolina 27511
Principal Investigator: Frank Tortora, MD
Phone: 919-467-3203
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Cary, NC
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Charlotte, North Carolina 28210
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Charlotte, NC
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Denver, Colorado 80218
Principal Investigator: James Lukban, MD
Phone: 303-955-8059
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Denver, CO
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Fort Wayne, Indiana 46825
Principal Investigator: Craig E. Hanson, MD
Phone: 260-432-4400
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Fort Wayne, IN
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Gastonia, North Carolina 28054
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Grand Rapids, Michigan 49503
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Hamlet, North Carolina 28345
Principal Investigator: Janice Harris-Hicks
Phone: 910-205-8909
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Hamlet, NC
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Hialeah, Florida 33016
Principal Investigator: Edward Gheiler, MD
Phone: 305-822-7227
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Hialeah, FL
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4601 West Bonanza Road
Las Vegas, Nevada 89102
Principal Investigator: Vani Dandolu, MD
Phone: 704-944-2805
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Las Vegas, NV
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New York, New York 10065
Principal Investigator: Bilal Chughtai, MN
Phone: 646-962-9395
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North Wales, Pennsylvania 19454
Principal Investigator: Miles Murphy, MD
Phone: 610-390-8204
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North Wales, PA
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Gennady Slobodov, MD
Phone: 405-271-6966
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Omaha, NE
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Raleigh, North Carolina 27607
Principal Investigator: Mark Jalkut, MD
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Raleigh, NC
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Sherbrooke, Quebec
Principal Investigator: Le-Mai Tu, MD
Phone: 819-346-1110
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Sherbrooke,
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Sioux Falls, South Dakota 57104
Principal Investigator: Kevin Benson, MN
Phone: 605-328-8777
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Springfield, Massachusetts 01199
Principal Investigator: Oz Harmanli, MD
Phone: 413-794-5857
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Eric Sokol, MD
Phone: 650-724-7846
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Virginia Beach, Virginia 23456
Principal Investigator: M. Mehdi Parva, MD
Phone: 757-471-3375
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West Columbia, South Carolina 29169
Principal Investigator: Brian Willard, MD
Phone: 803-796-9968
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Winston-Salem, North Carolina 27103
Principal Investigator: Bradley Jacobs, MD, FACOG
Phone: 336-397-3715
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Zanesville, Ohio 43701
Principal Investigator: Mitesh Parekh, MD
Phone: 740-454-8551
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Zanesville, OH
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