Patients scheduled for thoracic surgery will be identified as potential candidates and recruited by a research coordinator before surgery. Research subjects will be randomized to either early or late post-operative urinary catheter (a thin flexible tube placed into the bladder to drain urine) removal. Thoracic epidural analgesia (TEA), a thin tube placed near the spinal cord, will remain functioning after urinary catheter removal for the early group. The study group randomized to early catheter removal will have urinary catheters removed 24 hours after surgery is completed. Study subjects that are randomized to late removal of urinary catheter will have urinary catheters removed after TEA is discontinued as routine clinical care (usually 4-5 days). Determination of bladder urine volume will be made by sound wave examination (ultrasound) by appropriately-trained staff. Following indwelling urinary catheter removal, research subjects may receive a brief urine drain tube as standard clinical care. Laboratory urine analysis will be obtained from urine following removal of urinary catheter and assessed for urinary tract infection (UTI).
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.
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.
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.
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..
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.
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.