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

Not Applicable

Completed

Conditions: Stress Urinary Incontinence

Interventions: Device: Altis® Single Incision Sling System (SIS)

Registration Number: NCT01272284

Lead Sponsor: Coloplast A/S

Brief 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 113

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Altis® SIS	Altis® Single Incision Sling System (SIS)	Subjects enrolled with Altis® SIS

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months	6 months (compared to baseline)	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

Name	Time	Method
Percentage of Participants With Negative Cough Stress Test at 12 Months	12 months (compared to baseline)	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 IIQ-7 From Baseline to 12 Months	12 months (compared to baseline)	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 Participants With Negative Cough Stress Test at 6 Months	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.
Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months	6 months (compared to baseline)	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% Reduction in 24-hour Pad Weight From Baseline to 12 Months	12 months (compared to baseline)	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.
Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months	12 months (compared to baseline)	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 Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months	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).
Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months	6 months (compared to baseline)	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	6 months (compared to baseline)	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	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).

Trial Locations

Locations (17): Tri Valley Urology
🇺🇸
Murrieta, California, United States
Atlanta Medial Research Institute
🇺🇸
Alpharetta, Georgia, United States
Female Pelvic Medicine & Urogynecology Institute of Michigan
🇺🇸
Grand Rapids, Michigan, United States
Bellevue ObGyn
🇺🇸
Bellevue, Nebraska, United States
Greenville Hospital System
🇺🇸
Greenville, South Carolina, United States
Carolina Urology Partners
🇺🇸
Gastonia, North Carolina, United States
The Group for Women
🇺🇸
Norfolk, Virginia, United States
Carolina Urologic Research Center
🇺🇸
Myrtle Beach, South Carolina, United States
CHUS Hopital Fleurimont
🇨🇦
Sherbrooke, Quebec, Canada
Eastern Virginia Medical School
🇺🇸
Norfolk, Virginia, United States
University of Illinois at Chicago - Department of Urology
🇺🇸
Chicago, Illinois, United States
Illinois Urogynecology, LTD
🇺🇸
Oak Lawn, Illinois, United States
Urology Specialists, LLC
🇺🇸
Hialeah, Florida, United States
Rosemark Womencare Specialist
🇺🇸
Idaho Falls, Idaho, United States
Delaware Valley Urology
🇺🇸
Voorhees, New Jersey, United States
The University of Oklahoma Health Sciences Center
🇺🇸
Oklahoma City, Oklahoma, United States
Johnston Willis Medical Center
🇺🇸
Richmond, Virginia, United States