Overactive bladder (OAB) is a clinical diagnosis characterized by the presence of bothersome urinary symptoms including urgency, frequency, nocturia, and urgency incontinence. Urinary incontinence is a prevalent condition that markedly impacts quality of life affecting both men and women. This investigation is a study of the Valencia Technologies eCoin system for people experiencing the accidental leakage of urine. If you choose to participate in this trial, you will have the eCoin device placed under the skin in your right or left leg near your ankle. The device will attempt to improve or restore normal control of your bladder by sending out electrical impulses to the tibial nerve. The electrical stimulation comes from a small device that is slightly larger than a nickel. The stimulation pulse intensity is adjusted to your highest comfortable level. An engineer will do this programming at the study center using an external controller. After activation, the implant automatically provides 30 minute stimulation sessions according to a fixed interval schedule. For the first 12 weeks of therapy, you will get your 30 minute session every third day. After 12 weeks, you will get your 30 minute sessions every fourth day. The time of day may vary from session to session. The duration of the study is 56 weeks.
The purpose of this study is to evaluate Nivolumab or Nivolumab plus Experimental Medication BMS-986205 with or without BCG (bacillus Calumette-Guerinin) BCG-Unresponsive non-muscle invasive Bladder Cancer. You will be randomized (assigned by chance) to receive treatment in either Arm A, Arm B, Arm C or Arm D. Arm A is Nivolumab alone, Arm B is Nivolumab and BCG (Bacille Calmette Guerin), Arm C is Nivolumab with IDO1 Inhibitor (BMS-986205), and Arm D is Nivolumab with IDO1 Inhibitor (BMS-986205) and BCG . An IDO1 inhibitor (such as BMS-986205) is designed to block the function of a protein (called an enzyme), called IDO1 within the body.Blocking the IDO pathway may help the immune system to fight abnormal cancer cells in the body.This is an open label study which means both you and your doctor will know which treatment you are receiving. You will take your assigned study medication as assigned based on your treatment arm for 52 weeks
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.