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

Silhouette
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

A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT® FOR THE TREATMENT OF URINARY INCONTINENCE IN SUBJECTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY OR MULTIPLE SCLEROSIS Save

Date Added
August 9th, 2016
PRO Number
Pro00058027
Researcher
Lindsey Cox

Silhouette
Keywords
Bladder, Multiple Sclerosis, Spinal Cord
Summary

The main objective of this study is to evaluate if Dysport® is effective and safe for the treatment of urinary incontinence due to NDO.

Dysport® contains a toxin that is produced from bacteria. The toxin is called Botulinum toxin A and it is known that this toxin causes muscles that are contracting too much to relax once the muscles are injected with the toxin. This relaxation usually lasts for several months before treatment needs to be given again.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
843792-2325

Long-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 8 to 17 Years of Age Save

Date Added
July 9th, 2013
PRO Number
Pro00024164
Researcher
Andrew Stec

Silhouette
Keywords
Bladder, Pediatrics, Urinary
Summary

This is a multicenter study is to investigate the long-term safety and effectiveness of BOTOX® injections into the bladder of children that have accidental loss of urine due to neurogenic detrusor overactivity (NDO). Approximately 100 subjects will participate in this study. Patients have to have completed the Allergan Study 191622-120 and be qualified to be retreated.

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

BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 8 to 17 Years of Age Save

Date Added
June 25th, 2013
PRO Number
Pro00024123
Researcher
Andrew Stec

Silhouette
Keywords
Bladder, Pediatrics, Urinary
Summary

This is a multicenter, randomized, double-blind, parallel group study to evaluate the efficacy and safety of BOTOX in patients with urinary incontinence due to neurogenic detrusor overactivity who are 8 to 17 years of age. Patients will be evaluated during a screening period for eligibility. Eligible patients will be randomized and receive treatment on day 1.Patients will have posttreatment follow-up clinic visits at weeks 2, 6, and 12. Thereafter, patients will have alternating telephone and clinic follow-up visits every 6 weeks until they exit the study. Patients exit the study once they qualify for retreatment, or at week 48 if the patient never qualifies for retreatment. Request for retreatment can occur at any scheduled clinic or telephone visit or between scheduled visits from week 12 onwards. If the patient qualifies for retreatment they will exit the study, so the visit at which the patient qualifies for retreatment will also become the exit visit..

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

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Cemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma Save

Date Added
March 7th, 2011
IRB Number
20167
Researcher
Michael Lilly

Silhouette
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Urinary
Summary

The purpose of this study is to compare the effects, good and/or bad, of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on you and your transitional cell cancer to find out which is better. Bevacizumab is an antibody that we think can block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.

Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing and are expected to be very similar in safety and effectiveness. The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being done to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of your cancer and allow you to live longer.

This is a randomized trial so patients will receive one of two treatments: Arm A: Gemcitabine, cisplatin, and placebo (sugar water or salt water)OR Arm B: Gemcitabine, cisplatin, and bevacizumab (an experimental drug). Arm A is the current standard treatment for patients with this type of cancer. Your participation in this trial will continue for as long the cancer is responding to or is stabilized by the drugs and you do not have any severe side effects from the drugs.

Institution
MUSC
Recruitment Contact
Alan Brisendine
843-792-9007
matsont@musc.edu

A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy Save

Date Added
October 5th, 2009
IRB Number
19018
Researcher
David Marshall

Silhouette
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Urinary
Summary

The purpose of this study is to find out what effects (good and/or bad) chemotherapy combined with external radiation therapy and possible removal of your bladder has on you and your cancer. The chemotherapy drugs used in this study (5-Fluorouracil, cisplatin, and gemcitabine) are not experimental drugs. This research is being done because we do not know whether one combination of drugs with radiation is superior to another in the treatment of your disease. This study uses similar therapies to the standard treatment, but chemotherapy and radiation therapy are given before removal of the bladder is considered. In this study, bladder removal is advised if, after chemotherapy and radiation, your tumor has not completely disappeared, if your tumor comes back, or if it gets larger.

Patients who participate in this trial will be randomized into two groups. Patients will receive either cisplatin and 5-FU chemotherapy and radiation twice per day OR gemcitabine chemotherapy and radiation once per day. Participation in this study may last up to 8 months with continued follow up after treatment is complete.

Institution
MUSC
Recruitment Contact
Alan Brisendine
843-792-9007
brisend@musc.edu

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