Clinical trial NCT02348112: Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
Altis 522
urinary incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 416
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from urology or urogynecology specialties.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 6 months
measure: Primary Safety Endpoint
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: Pelvic Solutions Center
state: Colorado
city: Hialeah
country: United States
facility: Urology Specialists, LLC
state: Florida
city: Idaho Falls
country: United States
facility: Rosemark Women Care Specialists
state: Idaho
city: Fort Wayne
country: United States
facility: Women's Health Advantage
state: Indiana
city: Cambridge
country: United States
facility: Boston Urogynecology Associates
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Health System
state: Massachusetts
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine & Urogynecology
state: Michigan
city: Omaha
country: United States
facility: Adult and Pediatric Urology & Urogynecology
state: Nebraska
city: Las Vegas
country: United States
facility: University of Nevada
state: Nevada
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Cary
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health
state: North Carolina
city: Gastonia
country: United States
facility: Carolina Urology Partners
state: North Carolina
city: Hamlet
country: United States
facility: FirstHealth Urogynecology
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Akron
country: United States
facility: Akron Urogynecology Associates
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: North Wales
country: United States
facility: Institute of Female Pelvic Medicine & Reconstructive Surgery
state: Pennsylvania
city: West Columbia
country: United States
facility: Lexington Urology
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Virginia Beach
country: United States
facility: The Group for Women
state: Virginia
city: Sherbrooke
country: Canada
facility: CHUS Hopital Fleurimont
state: Quebec
Study officials:
affiliation: Rosemark WomenCare Specialists
name: Ty Erickson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erickson 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.