Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Completed

Conditions: Stress Urinary Incontinence

Interventions: Device: Transobturator or Retropubic Sling
Device: Altis Single Incision Sling

Registration Number: NCT02348112

Lead Sponsor: Coloplast A/S

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.

Detailed Description: This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) 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 urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 416

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 (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 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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comparator arm	Transobturator or Retropubic Sling	Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.
Altis arm	Altis Single Incision Sling	Subjects will have an Altis sling placed to treat stress urinary incontinence.

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	6 months	Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.
Primary Safety Endpoint	36 months	Observed device and/or procedure-related serious adverse events through 36 months.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (26): The Institute for Female Pelvic Medicine and Reconstructive Surgery
🇺🇸
Allentown, Pennsylvania, United States
CHUS Hopital Fleurimont
🇨🇦
Sherbrooke, Quebec, Canada
Urology Specialists, LLC
🇺🇸
Hialeah, Florida, United States
Carolina Urology Partners
🇺🇸
Gastonia, North Carolina, United States
Baystate Health System
🇺🇸
Springfield, Massachusetts, United States
Female Pelvic Medicine & Urogynecology
🇺🇸
Grand Rapids, Michigan, United States
Rosemark Women Care Specialists
🇺🇸
Idaho Falls, Idaho, United States
Women's Health Advantage
🇺🇸
Fort Wayne, Indiana, United States
FirstHealth Urogynecology
🇺🇸
Hamlet, North Carolina, United States
Boston Urogynecology Associates
🇺🇸
Cambridge, Massachusetts, United States
Albany Medical Center
🇺🇸
Albany, New York, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Genesis Healthcare
🇺🇸
Zanesville, Ohio, United States
The Group for Women
🇺🇸
Virginia Beach, Virginia, United States
Institute of Female Pelvic Medicine & Reconstructive Surgery
🇺🇸
North Wales, Pennsylvania, United States
Sanford Health
🇺🇸
Sioux Falls, South Dakota, United States
Novant Health
🇺🇸
Charlotte, North Carolina, United States
Associated Urologists of North Carolina
🇺🇸
Raleigh, North Carolina, United States
Lexington Urology
🇺🇸
West Columbia, South Carolina, United States
Stanford University
🇺🇸
Stanford, California, United States
University of Nevada
🇺🇸
Las Vegas, Nevada, United States
Akron Urogynecology Associates
🇺🇸
Akron, Ohio, United States
Pelvic Solutions Center
🇺🇸
Denver, Colorado, United States
Adult and Pediatric Urology & Urogynecology
🇺🇸
Omaha, Nebraska, United States
Lyndhurst Clinical Research
🇺🇸
Winston-Salem, North Carolina, United States
University of Oklahoma
🇺🇸
Oklahoma City, Oklahoma, United States