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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
113
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.
Tri Valley Urology
Murrieta, California, United States
Urology Specialists, LLC
Hialeah, Florida, United States
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%.
Time frame: 6 months (compared to baseline)
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.
Time frame: 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.
Time frame: 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%.
Time frame: 6 months (compared to baseline)
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Atlanta Medial Research Institute
Alpharetta, Georgia, United States
Rosemark Womencare Specialist
Idaho Falls, Idaho, United States
University of Illinois at Chicago - Department of Urology
Chicago, Illinois, United States
Illinois Urogynecology, LTD
Oak Lawn, Illinois, United States
Female Pelvic Medicine & Urogynecology Institute of Michigan
Grand Rapids, Michigan, United States
Bellevue ObGyn
Bellevue, Nebraska, United States
Delaware Valley Urology
Voorhees Township, New Jersey, United States
Carolina Urology Partners
Gastonia, North Carolina, United States
...and 7 more locations
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%.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 12 months