Urinary incontinence affects over 13 million men and women of all ages in the United States. Stress urinary incontinence (SUI) affects primarily women and is generally caused by two conditions—intrinsic sphincter deficiency (ISD) and hypermobility. These conditions may occur independently or in combination. In ISD, the urinary sphincter valve, located within the urethra, fails to close (or “coapt”) properly, causing urine to leak out of the urethra during stressful activity. Hypermobility is a condition in which the pelvic floor is distended, weakened, or damaged, causing the bladder neck and proximal urethra to rotate and descend in response to increases in intra-abdominal pressure (e.g., due to sneezing, coughing, straining, etc.). The result is that there is an insufficient response time to promote urethral closure and, consequently, urine leakage and/or flow results. Moreover, the condition of stress urinary incontinence is often compounded by the presence of untreated vaginal vault prolapse or other more serious pelvic floor disorders. Often, treatments of stress incontinence are made without treating the pelvic floor disorders, potentially leading to an early recurrence of the pelvic floor disorder.
Pelvic floor disorders are often treated using an implantable supportive sling. Such slings may be made from a variety of materials, and often incorporate two different types of material connected via mechanical fixation devices, such as staples and sutures. When one of the materials is a biologic material, the surgeon must suture the two materials together, a labor-intensive and time-consuming process. Eliminating the need for fixation devices and the need for suturing can reduce costs for producing and utilizing implantable slings.