Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

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 Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Transobturator or Retropubic Sling; Device: Altis Single Incision Sling

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.

• Study Type: Observational
• Enrollment (Actual): 416

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS Hopital Fleurimont
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80218
      • Pelvic Solutions Center
  • Florida
    • Hialeah, Florida, United States, 33016
      • Urology Specialists, LLC
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rosemark Women Care Specialists
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Women's Health Advantage
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Boston Urogynecology Associates
    • Springfield, Massachusetts, United States, 01199
      • Baystate Health System
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Female Pelvic Medicine & Urogynecology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult and Pediatric Urology & Urogynecology
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University of Nevada
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Associated Urologists of North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Novant Health
    • Gastonia, North Carolina, United States, 28054
      • Carolina Urology Partners
    • Hamlet, North Carolina, United States, 28345
      • FirstHealth Urogynecology
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
  • Ohio
    • Akron, Ohio, United States, 44313
      • Akron Urogynecology Associates
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Zanesville, Ohio, United States, 43701
      • Genesis Healthcare
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • The Institute for Female Pelvic Medicine and Reconstructive Surgery
    • North Wales, Pennsylvania, United States, 19454
      • Institute of Female Pelvic Medicine & Reconstructive Surgery
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Lexington Urology
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Health
  • Virginia
    • Virginia Beach, Virginia, United States, 23456
      • The Group for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from urology or urogynecology specialties.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Altis arm; Subjects will have an Altis sling placed to treat stress urinary incontinence.	Device: Altis Single Incision Sling; Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.
Comparator arm; Subjects will have a transobturator or retropubic sling placed to treat stress urinary incontinence.	Device: Transobturator or Retropubic Sling; Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed rates for the following: organ perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary or neuromuscular problems	To demonstrate that the rate of device and/or procedure related adverse events defined as organ perforation, bleeding, mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems and neuromuscular problems associated with use of Altis SIS is non-inferior compared to the rate associated with use of transobturator and/or retropubic slings at 36 months.	36 months
Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50%.	To demonstrate a reduction from baseline in 24 hour pad weight of at least 50%.	12, 18, 24, and 36 months
Quality of Life assessment	Measured through the following questionnaires: Patient Global Impression of Improvement (PGI-I), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7), Surgical Satisfaction Questionnaire (SSQ-8), Visual Analog Scale for Pain (VAS Pain)	6, 12, 18, 24, and 36 months
Observed adverse events of the index procedure	To assess the rates, severity, and relatedness of all observed adverse events (including mesh exposure and erosion) associated with both study groups at 6 months, 12 months, 18 months, 24 months, and 36 months.	6, 12, 18, 24, and 36 months
Observed revision/re-surgery	To assess the rates all revisions/re-surgeries observed associated with both study groups at 6 months, 12 months, 18 months, 24 months, and 36 months.	6, 12, 18, 24, and 36 months
Observed effectiveness for subjects considered dry (pad weight less than or equal to 4.0 grams)	To assess the effectiveness for subjects considered dry (pad weight less than or equal to 4.0 grams)	6, 12, 18, 24, and 36 months

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Ty Erickson, MD, Rosemark WomenCare Specialists

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: January 16, 2015
• First Submitted That Met QC Criteria: January 22, 2015
• First Posted (Estimated): January 28, 2015

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: stress urinary incontinence; urinary incontinence; Altis 522
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SU020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO