This study is for females 22 years or older who have been diagnosed with stress urinary incontinence with primary intrinsic sphincter deficiency. Subjects are being invited to take part in a research study using a device called the ACT (Adjustable Continence Therapy for Women). ACT is an adjustable implantable silicone device for the treatment of unwanted loss of urine during activity (stress incontinence). The purpose of this study will be to find out if the implant of the ACT is safe and effective in reducing unwanted urine loss. The study will involve about 167 women that have unwanted urine loss. Participation is voluntary. This system is investigational which means it is not approved by the U.S Food and Drug Administration (FDA). After placement of the devices, subjects will be followed for 12 months on a regular visit schedule. Annual visits may continue for up to 5 years (subjects will only come to clinic one time a year after the first year in the study).
This study will collect prospective data on clinical indications, outcomes, and adverse events related to Prostatic Artery Embolization (PAE) at the Medical University of South Carolina. Patients undergoing surgical treatment for benign prostatic obstruction causing LUTS will also be allowed to enroll in this registry for the purposes of comparison. Patients will be followed at 1, 3, and 12 months post-procedure, for a period of up to 5 years. Patients will remain enrolled in the registry for a period of 5 years.