Composur will be a prospective study in patients with overactive bladder (OAB) in the United States (US) who are treated with the drug vibegron as single drug therapy for the treatment of OAB. The aim of this study is to understand how the study drug performs in real-world every day practice. This is a observational study that will require you will be asked to attend 4 visits at the study clinic and 2 telephone calls: Day 1 (Visit 1), then at 4-6 weeks (Visit 3), 12-20 weeks (Visit 4) and 24-36 weeks (Visit 5) after Day 1. Visit 2 will be a telephone call and at 12 months (Visit 6), one additional telephone call will occur. A monthly contact after the initial visit will occur for one year but can be extended to 2 years upon the Sponsor's decision.
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 [25]. 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 [26] and re-do mid urethral sling was reported to have only 53% success over 17 months of follow-up [9].
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.