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Trial record 1 of 1 for:    NCT01272284
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The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01272284
First received: January 5, 2011
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Stress Urinary Incontinence
Device: Altis® Single Incision Sling System (SIS)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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%.


Secondary Outcome Measures:
  • Percentage of Participants With Negative Cough Stress Test at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months [ Time Frame: 6 months (compared to baseline) ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months [ Time Frame: 6 months (compared to baseline) ] [ Designated as safety issue: No ]
    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%.

  • Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months [ Time Frame: 6 months (compared to baseline) ] [ Designated as safety issue: No ]
    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%.

  • Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months [ Time Frame: 12 months (compared to baseline) ] [ Designated as safety issue: No ]
    Success defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months.

  • Percentage of Participants With Negative Cough Stress Test at 12 Months [ Time Frame: 12 months (compared to baseline) ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months [ Time Frame: 12 months (compared to baseline) ] [ Designated as safety issue: No ]
    Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)

  • Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months [ Time Frame: 12 months (compared to baseline) ] [ Designated as safety issue: No ]
    Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)

  • Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 113
Study Start Date: December 2010
Study Completion Date: January 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Altis® SIS
Subjects enrolled with Altis® SIS
Device: Altis® Single Incision Sling System (SIS)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272284

Locations
United States, California
Tri Valley Urology
Murrieta, California, United States, 92562
United States, Florida
Urology Specialists, LLC
Hialeah, Florida, United States, 33016
United States, Georgia
Atlanta Medial Research Institute
Alpharetta, Georgia, United States, 30005
United States, Idaho
Rosemark Womencare Specialist
Idaho Falls, Idaho, United States, 83404
United States, Illinois
University of Illinois at Chicago - Department of Urology
Chicago, Illinois, United States, 60612
Illinois Urogynecology, LTD
Oak Lawn, Illinois, United States, 60453
United States, Michigan
Female Pelvic Medicine & Urogynecology Institute of Michigan
Grand Rapids, Michigan, United States, 49503
United States, Nebraska
Bellevue ObGyn
Bellevue, Nebraska, United States, 68123
United States, New Jersey
Delaware Valley Urology
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Carolina Urology Partners
Gastonia, North Carolina, United States, 28054
United States, Oklahoma
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
The Group for Women
Norfolk, Virginia, United States, 23502
Johnston Willis Medical Center
Richmond, Virginia, United States, 23235
Canada, Quebec
CHUS Hopital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Ervin Kocjancic, MD University of Chicago, Chicago, IL, United States
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01272284     History of Changes
Other Study ID Numbers: CP006SU
Study First Received: January 5, 2011
Results First Received: September 27, 2013
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Coloplast A/S:
Female
Stress urinary incontinence
Mini sling
Single incision sling
Urinary incontinence
Mixed urinary incontinence
Additional relevant MeSH terms:
Stress
Urinary Incontinence
Urinary Incontinence, Stress
Pathological Processes
Urination Disorders
Urological Disorders
Urological Manifestations
Signs and Symptoms

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 24, 2014