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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01272284
First received: January 5, 2011
Last updated: September 27, 2013
Last verified: September 2013
  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.


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:
  • To Assess Improvement in Subject Incontinence Via 24-hour Pad Weight as Defined by a Reduction in Pad Weight From Baseline to 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Characterize Incontinence Via Cough Stress Test at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To Characterize Incontinence Via Subject Voiding Diary at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To Assess Subject Quality of Life Via Validated Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Validated Questionnaire: Urogenital Distress Inventory (UDI-6 SF)

  • Assess Patient Satisfaction Via Validated Quality of Life Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Validated Questionnaire: Incontinence Impact Questionnaire-Short Form (IIQ-7)

  • Assess Patient Satisfaction Via Validated QOL Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Validated Questionnaire: Patient Global Impression of Improvement (PGI-I)

  • To Assess Improvement in Subject Incontinence Via 24-hour Pad Weight as Defined by a Reduction in Pad Weight From Baseline to 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To Characterize Incontinence Via Cough Stress Test at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assess Patient Satisfaction Via Validated Quality of Life Questionnaire UDI-6 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Validated Questionnaire: UDI-6

  • Assess Patient Satisfaction Via Validated Quality of Life Questionnaire IIQ-7 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Validated Questionnaire: IIQ-7

  • Assess Patient Satisfaction Via Validated Quality of Life Questionnaire PGI-I [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Validated Questionnaire: PGI-I


Enrollment: 113
Study Start Date: December 2010
Estimated Study Completion Date: February 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 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
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
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
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: September 27, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on April 17, 2014