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Stress Urinary IncontinenceNCT01272284

The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

A study testing Altis® Single Incision Sling System (SIS) in people with Stress Urinary Incontinence, run by Coloplast A/S at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Stress Urinary Incontinence
What is being tested?
Altis® Single Incision Sling System (SIS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
17 sitesin 2 countries
Study dates
Dec 2010to Jan 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is female at least 18 years of age
  • Subject is able and willing to complete all procedures and follow-up visits indicated in this protocol
  • 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

Who cannot join

  • Subject has an active urogenital infection or active skin infection in region of surgery
  • Subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading
  • Subject is having a concomitant pelvic floor procedure
  • 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)
  • Subject had a prior surgical SUI treatment
  • Subject has undergone radiation or brachy therapy to treat pelvic cancer
Show all 11Show fewer
  • Subject has urge predominant incontinence
  • Subject has an atonic bladder or a post void residual (PVR) consistently about 100cc
  • Subject is pregnant and/or is planning to get pregnant in the future
  • Subject has a contraindication to the surgical procedure or the Altis Instructions For Use (IFU)
  • Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsor's approval

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States16 sites

  • Atlanta Medial Research Institute

    Alpharetta, Georgia, 30005

  • Bellevue ObGyn

    Bellevue, Nebraska, 68123

  • University of Illinois at Chicago - Department of Urology

    Chicago, Illinois, 60612

  • Carolina Urology Partners

    Gastonia, North Carolina, 28054

  • Female Pelvic Medicine & Urogynecology Institute of Michigan

    Grand Rapids, Michigan, 49503

  • Greenville Hospital System

    Greenville, South Carolina, 29605

  • Urology Specialists, LLC

    Hialeah, Florida, 33016

  • Rosemark Womencare Specialist

    Idaho Falls, Idaho, 83404

  • Tri Valley Urology

    Murrieta, California, 92562

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • The Group for Women

    Norfolk, Virginia, 23502

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Illinois Urogynecology, LTD

    Oak Lawn, Illinois, 60453

  • The University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Johnston Willis Medical Center

    Richmond, Virginia, 23235

  • Delaware Valley Urology

    Voorhees Township, New Jersey, 08043

Other trials in United States

Canada1 site

  • CHUS Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).

Read the detailed description

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI). Primary Objective: Improvement in continence measured by 24 hour pad weight test with at least a 50% reduction in weight from baseline at 6 months. Secondary Objectives: Cough stress test results at 6 months; Subject QoL as measured by validated questionnaires: PGI-I, improvements in UDI-6 and IIQ-7 scores from baseline at 6 months, 3 day voiding diary improvement from baseline at 6 months; Device and procedure related adverse events. Brief Entrance Criteria: Adult female with confirmed SUI through cough stress test or urodynamics; Failed two non-invasive incontinence therapies; No prior surgical SUI treatment; No prolapse POP-Q Stage 2 or higher; No concurrent pelvic floor procedure; No urge predominant incontinence; No incontinence due to neurological disorder/disease; No PVR > 100cc; and, No contraindication to the surgical procedure. Study visits will take place at baseline, implant/hospitalization, 3 months, 6 months, 1 year, and 2 years post operatively. This study will enroll up to 113 subjects at up to 17 investigative sites in the US and Internationally.

Being tested
Altis® Single Incision Sling System (SIS)
Keywords
Female, Stress urinary incontinence, Mini sling, Single incision sling, Urinary incontinence, Mixed urinary incontinence, Additional relevant MESH terms:, Stress, Urinary Incontinence, Stress, Pathological Processes, Urination Disorders, Urological Disorders, Urological Manifestations, Signs and Symptoms
Medical subject headings
Urinary Incontinence, Stress, Urinary Incontinence, Pathologic Processes, Urination Disorders, Urologic Diseases, Urological Manifestations, Signs and Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Altis® Single Incision Sling System (SIS)Device

    The Altis® SIS is a permanently implantable synthetic sling for females placed at the mid-urethra to provide a scaffold for tissue in-growth and support for stress urinary incontinence.

Study groups in NCT01272284
Study groupRoleWhat they receive
Altis® SISOtherSubjects enrolled with Altis® SIS
Receives: Device: Altis® Single Incision Sling System (SIS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months

    Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%.

    Measured: 6 months (compared to baseline)

Secondary outcomes (10)

  1. Percentage of Participants With Negative Cough Stress Test at 6 Months

    Endpoint defined as a negative result at 6 months, as measured by the Cough Stress Test (CST), in which the percent of subjects with a negative CST is compared to a performance goal of 66%.

    The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test.

    Measured: 6 months

  2. Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months

    Endpoint defined as at least a 50% improvement from baseline to 6-months, as measured by 3-Day Voiding Diary, in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.

    Subjects completed a 3-Day Voiding Diary of controlled urinations and the number and amount of leaks experienced.

    Measured: 6 months (compared to baseline)

  3. Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months

    Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.

    Measured: 6 months (compared to baseline)

  4. Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months

    Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.

    Measured: 6 months (compared to baseline)

  5. Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months

    Success defined as a response of "Very Much Better" or "Much Better" at 6 months, as measured by validated Patient Global Impression of Improvement (PGI-I).

    Measured: 6 months

  6. Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months

    Success is defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months using the 24 hour pad weight test.

    Measured: 12 months (compared to baseline)

  7. Percentage of Participants With Negative Cough Stress Test at 12 Months

    Success defined as a negative result at 12 months, as measured by the Cough Stress Test (CST).

    The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test.

    Measured: 12 months (compared to baseline)

  8. Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months

    Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)

    Measured: 12 months (compared to baseline)

  9. Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months

    Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)

    Measured: 12 months (compared to baseline)

  10. Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months

    Success defined as a response of "Very Much Better" or "Much Better" at 12 months, as measured by validated Patient Global Impression of Improvement (PGI-I).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2012
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01272284
Sponsor's protocol ID
CP006SU
Status last verified
Jan 2021
First submitted
5 Jan 2011
Last updated
11 Feb 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Altis® Single Incision Sling System (SIS) in people with Stress Urinary Incontinence, run by Coloplast A/S at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months (time frame: 6 months (compared to baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01272284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.

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