A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients with Urinary Incontinence (LO-BOT) Save

Date Added
February 28th, 2017
PRO Number
Pro00063602
Researcher
Eric Rovner

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Keywords
Bladder
Summary

The main purpose of this study is to evaluate the effectiveness and safety of an alternative injection technique for BOTOX® in reducing urinary incontinence episodes up to 100% (complete continence) in comparison with a placebo (inactive substance). For the purposes of this study, both BOTOX® and placebo will be considered "study drug". In this study, if you choose to participate, you will receive at least one injection of study drug. For the first study drug injection, two thirds (66%) of the patients will receive BOTOX® and one third (33%) of the patients will receive placebo. The placebo substance in this trial is saline solution, such as is given to hospital patients who need to receive fluids through a vein. You and the study staff will not be told whether you are receiving BOTOX® or placebo, but the study doctor can find out in case of a medical emergency. Whether you receive BOTOX® or placebo in this study for the first injection will be decided by chance (like flipping a coin). Your chances of receiving BOTOX® or placebo are 2 to 1. Therefore, there is a 66% chance of receiving Botox® and a 33% chance of receiving placebo. The assignment to either BOTOX® or placebo is called randomization. Taking placebo is the same as not receiving any medication for your overactive bladder. The reason placebo is used in this study is to help the researchers know if any effects they see in the study are because of the test drug rather than the study volunteer's expectations that come from receiving an investigational drug in a research study. Please ask the study doctor or study staff if you have any questions about receiving the placebo. Twelve weeks after receiving the first study drug injection (BOTOX® or placebo), you may request a second study drug injection. The second study drug injection will be BOTOX® (no patient will receive placebo as the second injection). Requesting the second injection does not guarantee that you will receive it. Upon your request, you will go through a set of qualification procedures (criteria) to be deemed eligible for the second injection. You must meet the second injection criteria in order to receive the injection. This study will be open to males and females over the age of 18 and will last about 25 weeks or up to 53 weeks if another injection is given. It involves multiple visits and phone calls to the clinic.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-792-2325
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

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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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