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

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).

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.

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