A Phase 2a, Biphasic Adaptive Design Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared with the Individual Components Lidocaine and Heparin in Subjects with Interstitial Cystitis/Bladder Pain Syndrome Save

Date Added
February 9th, 2016
PRO Number
Pro00046798
Researcher
Eric Rovner
Keywords
Bladder
Summary

The purpose of this research study is to determine whether the study drug is safe and effective in controlling bladder pain in patients with Bladder Pain Syndrome / Interstitial Cystitis. The study drug, URG101, is an experimental drug that is being tested to see if it is effective in treating bladder pain. During this research study, you will be randomly assigned (like pulling a number from a hat) to either receive the study drug URG101 (a mixture of Lidocaine and Heparin), lidocaine alone, heparin alone, or a placebo. A placebo is a product that is made to look like the study drug, but contains no medication (like a sugar pill). In this study the placebo is the phosphate solution without lidocaine or heparin mixed in it. If you participate in this study during the run-in phase, you will have a 1 in 6 chance of receiving placebo during the research study and a 1 in 6 chance of receiving heparin alone. You will have a 1 in 3 chance of receiving lidocaine alone and a 1 in 3 chance of receiving the study drug (URG101). Your participation in this research study will last for approximately 3 days including a follow-up phone call 48 or 72 hours after receiving the study drug.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

OUTCOMES OF PATIENTS WITH AUTOLOGUS MID-URETHRAL SLING AFTER FAILURE OF MID-URETHRAL MESH SLING Save

Date Added
June 29th, 2012
PRO Number
Pro00012059
Researcher
Eric Rovner
Keywords
Urinary
Summary

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.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
ude.csum@njiknej

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