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 properly (coapt), 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.
A popular treatment of SUI is the use of a sling, which is permanently placed under a patient's bladder neck or mid-urethra to provide a urethral platform. Placement of the sling limits the endopelvic fascia drop, while providing compression to the urethral sphincter to improve coaptation. Generally, the sling is surgically placed under urethra, close to the high-pressure zone with no elevation of the urethra. The ends of a sling are secured to an anatomical location by, for example, a bone anchor. Recent advances in surgical techniques have demonstrated the effectiveness of approaches without employing bone anchors toward mid-urethra sling stabilization. However, the bone anchor-less techniques typically require the use of large diameter delivery devices. For example, some procedures require ⅛ to ¼ inch diameter delivery devices to create a tract in which the sling would lie. Such a large tract may cause the patients pain for weeks. Further, the typical sling made from woven mesh may also narrow when tensioned during placement, which results in less stable placement in tissue.
Accordingly, there is a need for an improved surgically implantable sling or sling-like support having a low profile, and which does not narrow during placement.