Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

November 29, 2023 updated by: Coloplast A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
416

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: 6 months
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
Time Frame: 36 months
Observed device and/or procedure-related serious adverse events through 36 months.
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 36 months
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%.
Time Frame: 12, 18, 24, and 36 months
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
Time Frame: 6, 12, 18, 24, and 36 months
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
Time Frame: 6, 12, 18, 24, and 36 months
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
Time Frame: 6, 12, 18, 24, and 36 months
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)
Time Frame: 6, 12, 18, 24, and 36 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coloplast A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ty Erickson, MD, Rosemark WomenCare Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SU020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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