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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Altis® Single Incision Sling System (SIS)

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	6 months (compared to baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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.	6 months (compared to baseline)
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%.	6 months (compared to baseline)
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%.	6 months (compared to baseline)
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).	6 months
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.	12 months (compared to baseline)
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.	12 months (compared to baseline)
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)	12 months (compared to baseline)
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)	12 months (compared to baseline)
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).	12 months

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Ervin Kocjancic, MD, University of Chicago, Chicago, IL, United States

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 5, 2011
• First Submitted That Met QC Criteria: January 5, 2011
• First Posted (Estimate): January 7, 2011

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Stress; Urinary incontinence; Stress urinary incontinence; Female; Urinary Incontinence, Stress; Signs and Symptoms; Urination Disorders; Mixed urinary incontinence; Pathological Processes; Mini sling; Single incision sling; Additional relevant MESH terms:; Urological Disorders; Urological Manifestations
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: CP006SU