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).
Mid-urethral slings have been widely accepted as a treatment of choice for patients with stress urinary incontinence (SUI). Mid-Urethral sling surgery has been associated with good success rate and minimal morbidity.Minor complications are associated with these surgeries including bladder perforation, urethral injury or post operative complication such as de novo urgency and urge urinary incontinence, urinary retention or incomplete bladder emptying. Treatment approaches for complications included sling excision and urethral/bladder/ vaginal defect repair after sling intrusion or extrusion into these organs. Treatments for postoperative voiding dysfunction include clean intermittent catheterization, mid-urethral sling lysis, sling incision and formal urethrolysis. With urethrolysis, obstruction has been reported to be relieved in 65% to 93 with preservation of continence in 80% to 100% while the rate of SUI postoperative is 0 % to 19%.autologus fascial sling for relieve of obstruction with 54% of patients had no recurrence of their SUI . On the other hand, there have been no published data on the use of autologus fascia lata pubovaginal sling to treat patient with recurrent SUI after incision of the mid-urethral mish slings. Urethral injection of bulking agent have been reported with 34% cure  and re-do mid urethral sling was reported to have only 53% success over 17 months of follow-up .
Our aim is to evaluate the subjective and objective outcomes of salvage treatment of failed mid-urethral mesh sling with sling incision, urethrolysis, autologus facial pubovaginal sling or other forms of diversion if needed. We also will evaluate if this procedure will help to improve in the quality of life of these patients.