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Actos Lawsuit: The urinary bladder is a hollow, balloon-like organ located in the pelvis that collects and stores urine until it is ready to be excreted from the body. Urine is produced in the kidneys and is transported to the bladder through two tube-like structures called ureters. Pressure from the accumulation of urine in the urinary bladder forces the wall of the bladder to contract producing the urge to urinate. The urine is then excreted from the bladder via the urethra (a thin tube that carries urine from the bladder to the outside of the body).

A basic understanding of the terminology used by doctors to describe the various subtypes of bladder tumors is important in order to more fully appreciate the various approaches to treatment, the treatment options, and the prognosis (chances for recovery). Superficial bladder tumors are those that are localized (confined) to the transitional epithelium (urothelium) – the layer of epithelial cells that lines the inside of the bladder wall and is in direct contact with the urine – but have not spread to the deeper layers of the bladder. Additionally, bladder tumors that have invaded the lamina propria but have not invaded the muscularis propria can be considered as superficial. Invasive bladder cancer refers to a bladder tumor that is either invading the muscularis propria – the deeper layer of muscle cells that forms the wall of the bladder – or the perivesical fat located beyond the bladder muscle. This type of tumor is referred to as muscle-invasive bladder cancer. Muscle-invasive bladder cancer carries a higher risk of spreading beyond the bladder (metastases) and must be treated more aggressively than superficial bladder cancer. The term metastatic bladder cancer is used when the cancer cells have spread beyond the bladder to distant sites.

Hematuria – Blood in the urine (hematuria) is often the first warning signal and the most common symptom of bladder cancer. It has been estimated that approximately 80% to 90% of patients with bladder cancer develop hematuria which is often painless. In some cases, sufficient numbers of red blood cells are present to turn the color of the urine to dark brown or red. This is known as gross hematuria and is easily recognized by the patient upon urinating. In other cases, insufficient numbers of red blood cells may be present in the urine to cause any evident changes in the color of the urine but red blood cells can be detected by examining the urine under a microscope. This type of hematuria is called microscopic hematuria and may also indicate the presence of bladder cancer. It is important to note that although hematuria is the most common symptom of bladder cancer.

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Actos Lawsuit: Cystoscopy is an important diagnostic tool that enables the physician to directly examine the urinary tract with an instrument called a cystoscope. During this procedure, which is usually performed by an urologist on an outpatient basis, the cystoscope – a long, flexible lighted tube – is inserted through the urethra (the tube that carries urine from the bladder to the outside of the body) and is advanced into the bladder. The cystoscope enables the doctor to view the bladder and urethra and look for any abnormalities including a tumor, infection, or obstruction. During this procedure, the physician may also remove a small piece of tissue from the bladder (biopsy) and submit the biopsy specimen to the pathology laboratory where it is examined under a microscope for the presence of cancer cells. If you have signs and symptoms suggestive of bladder cancer (hematuria and/or changes in bladder habits), your doctor will recommend a cystoscopy to rule out bladder cancer.

A small piece of bladder tissue (biopsy specim en) is obtained by the urologist during cystoscopy for microscopic evaluation. During the biopsy procedure, muscle tissue must be obtained as it is important to determine the extension of the tumor (how far the tumor has spread) since the treatment of superficial bladder cancer differs from muscle-invasive bladder cancer. The biopsy specimen will then be examined under a microscope by another doctor known as a pathologist.

In general, early diagnosis and treatment significantly improves the prognosis for patients with bladder cancer. A high level of suspicion of bladder cancer should be considered for any patient who presents with gross hematuria and known risk factors for the disease. Once the diagnosis is confirmed, patients are evaluated thoroughly to determine the stage (extent of spread) of the disease. The choice of treatment depends upon a variety of factors including the type of bladder cancer, stage of the disease, the presence of other underlying medical conditions, and the patient’s preferences.

Transurethral resection of the bladder tumor (TURBT) represents the primary treatment modality for superficial bladder cancer. During this procedure, which may be performed either under general or regional anesthesia, the tumor is removed using a cystoscope that is inserted into the bladder via the urethra. After surgical removal of the bladder tumor, any remaining cancer cells can be destroyed with either electrical current (fulguration) or with a high-energy laser.

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Actos Lawsuit: The term “intravesical therapy” refers to the instillation of a biological agent or a chemotherapy drug directly into the bladder in order to destroy any residual cancer cells. Intravesical therapy is a form of local drug therapy whereby the treatment is targeted directly at the site of the cancer (bladder) as opposed to systemic drug therapy where a drug is injected into a vein or is given orally and travels throughout the circulatory system in order to reach the target organ (e.g., bladder).

The most common type of intravesical therapy for superficial bladder cancer is immunotherapy with Bacillus Calmette-Guerin (BCG). BCG is a vaccine that is sometimes used to vaccinate people against tuberculosis. The rationale for using BCG for the treatment of superficial bladder cancer is to boost the body’s natural immune system to destroy the bladder cancer cells. It is thought that BCG induces regression of the bladder tumor through a non-specific inflammatory reaction at the tumor site. Intravesical therapy with BCG is a form of immunotherapy. Intravesical BCG immunotherapy is the treatment of choice for patients with carcinoma in situ (Stage Tis) where the bladder cancer is limited to the lamina propria of the bladder but has not invaded the surrounding tissue.

Patients who undergo a radical cystectomy for muscle-invasive bladder cancer also require urinary diversion reconstructive surgery to collect and eliminate urine. Urinary diversion, also known as urostomy, is the general term used to describe reconstructive surgical procedures that bypass the normal structures of the urinary system by creating a “diversion” or conduit for the passage of urine through an opening in the abdominal wall called a stoma.

Orthotopic continent diversion – In this type of continent diversion, a new bladder, called a neobladder, is created by the surgeon using a long segment of the small or large bowel that serves as a reservoir to collect and store the urine. One technique involves surgically connecting the neobladder to the urethra which enables the patient to void urine normally. This procedure may be more advantageous for younger patients who may not wish to wear a bag attached to the abdomen for collecting the urine.

Another potential side effect of radical cystectomy in men is nerve damage that results when the neurovascular bundles are not spared during surgery. Nerve damage often results in the loss of the ability to have an erection (erectile dysfunction). Younger men under age 60 have a greater likelihood of regaining erectile function following a radical cystectomy than men over age 60. Patients should discuss with their surgeon the advantages and disadvantages of using nerve-sparing procedures during radical cystectomy.

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Actos Lawsuit: In women, part of the vagina is also usually surgically removed during a radical cystectomy making sexual intercourse more difficult and painful. Intercourse may be made less painful by using lubricating gels, vaginal moisturizers, or vaginal dilators. Women who undergo radical cystectomy are, however, still capable of achieving sexual climax (orgasm). It is evident that radical cystectomy can have a significant impact on the sexual health of both men and women. Patients should talk openly with their doctor about the potential negative side-effects of radical cystectomy on their sexual well-being and discuss the options that may be available for resuming an active and pleasurable sexual relationship after surgery for bladder cancer.

Over the years, doctors have come to learn that radical cystectomy alone is not sufficient as the sole treatment modality for muscle-invasive bladder cancer because about 50% of patients develop recurrent distant metastasis after undergoing radical cystectomy. More recently, the role of systemic chemotherapy has become better defined in the management of patients with muscle-invasive bladder cancer. Systemic chem otherapy may be administered either before radical cystectomy in order to shrink the bladder tumor ( neoadjuvant chemotherapy) or it may be given following surgery to destroy any residual cancer cells remaining in the body (adjuvant chemotherapy).

An important study published in 2003 in the New England Journal of Medicine (Volume 349; pages 859-866) clearly demonstrated the benefits in terms of significantly prolonged survival among bladder cancer patients receiving neoadjuvant combination systemic chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) as compared to the survival rate for patients treated with radical cystectomy alone. The median survival rate over an 11-year period of patients in this study who were treated with neoadjuvant M-VAC systemic chemotherapy followed by radical cystectomy was 77 months compared to only 46 months for patients treated with radical cystectomy alone. Based on the results of this study, the use of neoadjuvant combination chemotherapy has becom e much more prevalent for the treatment of muscle-invasive bladder cancer.

The data supporting the use of adjuvant chemotherapy for high-risk bladder cancer patients remains controversial. Nevertheless, it is generally accepted that patients with Stage T3 or T4 tumors and/or the presence of cancer in one or more lymph nodes at the time of surgery should receive 4-6 cycles of chemotherapy with either GC (gemcitabine) or M-VAC. Patients should discuss with their physicians the benefits and potential side effects of either neoadjuvant or adjuvant chemotherapy approaches.

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Actos Lawsuit: Although radical cystectomy is currently considered as the first-line treatment modality for muscle-invasive bladder cancer, some patients may be either unwilling or, due to other underlying medical conditions, may not be eligible to undergo this surgical procedure. What are the treatment options available to these patients?

In recent years, doctors have developed a combination of three treatment modalities (trimodality therapy or multimodality therapy) consisting of transurethral resection (TUR), radiation therapy, and systemic chemotherapy as a means of eradicating the bladder tumor while, at the same time, preserving the patient’s own bladder. The primary advantages of the trimodality therapy approach is that it enables the patient to keep their own bladder by avoiding the need for a radical cystectomy and, thereby, experience an improved quality of life after treatment for bladder cancer.

Although some studies have reported similar survival rates between trimodality therapy and radical cystectomy for patients with muscle-invasive bladder cancer, some experts have expressed the opinion that the risk of local recurrence of the cancer along with the risk of metastatic disease is higher for patients treated with the trimodality approach as compared to patients undergoing radical cystectomy. For these reasons, radical cystectomy is currently still considered as the standard of care for most patients with muscle-invasive bladder cancer, while trimodality therapy is usually reserved for a small subset of patients who are either unwilling or unable to undergo radical cystectomy or those who may wish to enroll in a clinical trial involving trimodality therapy.

Currently, combination systemic chemotherapy is considered as the first-line treatment for patients with metastatic (Stage IV) bladder cancer. The chemotherapeutic regimen that has been used most commonly since 1990 for metastatic bladder cancer is M-VAC (methotrexate, vinblastine, doxorubicin, cisplatin). The median survival rate for patients with metastatic bladder cancer who are treated with M-VAC is only about one-year, however, a small percentage of patients achieve longer survival.

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Actos Lawsuit : You can live without a bladder. However, you still need something that can perform the two basic func­tions of the bladder: storing and emptying of urine. Physicians have come up with many ways over the years to accomplish these tasks, many of which are still used today. The simplest alternative is to place drainage tubes into the kidneys that come out through the skin and connect to bags on the abdomen. These tubes are known as nephrostomy tubes. Nephrostomy tubes are typically inserted into a person in the X-ray department by an interventional radiologist who uses some light sedation. For the patient, the bag provides an easy way to store urine and can be drained several times a day when convenient by opening a small valve on the bag. These tubes can be uncomfortable, however, and may also be easily removed if tugged; therefore, they are only reasonable solutions for a short period of time or for patients who are too ill to undergo surgery. It is also possible to surgically bring the ureters directly to the skin surface (called a cutaneous ureterostomy). The urine then can be collected with a bag attached to the skin around the opening. Unfortunately, the ureters are rela­tively small, and thus any scarring or narrowing of the opening can cause a blockage of urine. This tendency to get blocked also makes cutaneous ureterostomies a poor long-term solution.

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To provide a good long-term solution, surgeons most commonly use a portion of the small bowel to act as the new bladder. The identified piece of small bowel is removed from the main portion and is fashioned for its new use (see Question 79 for details). The urine that collects within this piece of bowel will ultimately be drained in one of three ways. First, the bowel can simply be left open at the skin for the urine to drain passively out into a bag that is attached to the abdomen. This type of drainage is known as a conduit, and the opening onto the skin is called a urostomy. Urine collects in the bag, which is then drained into a toilet several times each day. Second, the bowel can be sewn into a rough sphere con­nected to the skin by only a small, long channel. This channel prevents urine from leaking out but easily accommodates a small catheter. This is called a conti­nent urinary diversion. With this type of diversion, you must pass a catheter into the new bladder several times a day to drain the urine. This allows you to live without an ostomy bag, but for some patients, passing the catheter several times a day may be difficult or impossible. Third, the new bladder can be directly reattached to the urethra (called an orthotopic neobladder). This allows you to urinate almost normally, although you do need to learn to use different muscles, as the new bladder replacement.

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To understand cancer, we must first understand nor­mal functioning of the body. The body is made up of billions of cells. Each organ of the body is made up of several different types of specialized cells. For example, the liver has cells that filter toxins from the blood, and the brain has nerve cells (called neurons) that are able to conduct electrical signals. Perhaps the most familiar cells are skin cells. Every flake of dry skin is made of millions of cells that are constantly dying and being replaced with new cells. The growth of new cells is care­fully balanced to occur at the same rate as the death of old cells. Your body has many mechanisms in place to regulate the timing of the birth and death of cells. Unfortunately, if one of these mechanisms malfunc­tions, the careful balance can be disrupted. Environ­mental toxins such as cigarette smoke, chemicals, and radiation can damage DNA and can disrupt these control mechanisms. A tumor may develop when new cells are created faster than old cells die. Tumors can be either benign or malignant. A benign tumor is an overgrowth of cells that is unchecked by the body’s normal mechanisms; thus, it will keep getting bigger. It is called benign because it does not cause you illness. Some benign tumors can get to be so large that they do cause problems, especially if they are in a confined space, such as your skull. A malignant tumor is also an overgrowth of cells. The tumor is considered malignant, however, because the cells are no longer confined to the tumor. Cells may spread from the main tumor through the blood and lymph system or grow directly into nearby structures. As the cells begin to grow unchecked in new organs, they gradually cause dysfunction all over the body and may eventually even cause death.

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Actos Lawsuit : The bladder is the container in the body that stores urine. The other term for bladder is “vesical,” which is derived from the Latin word vesicular. The bladder is a soft, round structure that is located in the pelvis. The pubic bone is in front of the bladder; the rectum in men or the uterus in women is behind the bladder. Urine drains into the bladder through an opening on each side at the bottom of the bladder. Urine is stored in the bladder until a person is ready to urinate. In order to urinate, the muscle in the bladder wall squeezes, push­ing the urine out of the bladder through the urethra. In women, the urethra is short, only approximately 1 inch long. In men, it is much longer because it has to pass through the prostate and then the penis before finally opening at the tip of the penis.

In the middle of the abdomen, just beneath the lower ribs, are the kidneys. The kidneys filter the blood to produce urine. The urine that the kidneys produce exits the kidney through the renal pelvis and flows into the ureters. The ureters are soft, muscular tubes that are about the width of a pencil. They carry the urine from the kidneys down to the bladder, where they open into the base of the bladder.

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The adult bladder normally holds approximately 400 ml of urine. The bladder wall has three separate layers. The innermost layer that is in contact with the urine is a thin layer called the urothelium. The middle layer is made of muscle fibers that can squeeze. When the muscles contract, they increase the pressure inside the bladder, squeezing the urine out of the bladder. The outermost layer is a thin but protective layer called serosa.

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The bladder has two functions. The first is the storage of urine, and the second is the emptying of urine. In an infant, the bladder constantly fills and empties without any control by the brain. During toilet training, the brain learns to control the bladder, enabling it to hold (store) the urine until a time when it is socially accept­able to urinate. Emptying is the second function that the bladder must perform. In infancy, before toilet train­ing, this is actually the most important function of the bladder.

Although most of us take these two processes for granted, either one or both can malfunction. If the stor­age function fails, the bladder can become very small and contracted, holding just a tiny amount of urine before it needs to empty. In contrast, it may become floppy and dilated, holding several liters of urine before it is ready to empty. It can also become “overactive,” causing feelings of urgency and the need to urinate more than eight times per day. When the actual emptying function goes wrong, the bladder may only partially empty each time, leaving a high remaining amount of urine (the so-called postvoid residual). The bladder muscle may also weaken to the point where one is completely unable to urinate. This is called urinary retention.

When storing urine, the bladder must do so at a low pressure. This allows the new urine made in the kidneys to flow downward into the bladder. A safe bladder pres­sure is less than 40 cm H2O. When the pressures are higher than this, the urine may “back up” in the kidneys. High pressures in the kidneys over a long period of time may damage the kidneys. During urination, the bladder must squeeze to force the urine out. The pressure in the bladder at these times may be much higher than 40 cm H₂O, but it does not usually damage the kidneys.

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Actos Lawsuit News- 1/26/2012: Surgery can be as effective in elderly patients as in younger patients, but it does have a higher rate of postoperative complications in older individuals who have other medical problems (comorbidities). Elderly people are particularly sensitive to long-term complications, lilce the metabolic dis­turbances that can follow urinary diversion. In those aged 80 or older, the role of radical cystectomy is controversial. Although newer surgical techniques and improvements in care, before and after the operation, make this an option for increasing numbers of older patients, several studies suggest that its benefit is at best quite minimal, even in relatively fit octogenarians. You need to carefully weigh the benefits and risks of radical cystectomy with your multidisciplinary team before going through such an aggressive operation.

Because bladder cancer surgery can cause serious side effects and debilitation that requires significant healing time and energy, older patients usually tolerate neoadjuvant chemotherapy (given before surgery) better than adjuvant chemotherapy (given after surgery). On the other hand, because not all bladder cancer patients need chemotherapy, giving it after surgery (adjuvant therapy) offers the advantages of treating only those patients who absolutely need it. You should discuss the advantages and disadvantages of both approaches with your multi­disciplinary team.

With regard to choice of chemotherapy, healthy older patients can receive the same regimens as their younger counterparts, including those that are anthracycline-based, like MVAC (see Chapter 3). However, older patients are at increased risk of developing congestive heart failure from these regimens, and gemcitabine-cisplatin is probably a better choice, especially in those with a significant cardiac risk for anthracyclines. Recent studies have shown this regimen to be just as effective as MVAC but with fewer- side effects.

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Managing chemotherapy-associated toxicity with appropri­ate supportive care is crucial in the elderly population to give them the best chance of cure and survival or to provide the best palliation. Reducing tire dose of chemotherapy (or radiation therapy) based purely on chronological age may seriously affect the effectiveness of treatment. Those with metastatic disease may tolerate single-agent chemotherapy better, but tire presence of severe comorbidities, age-related frailly, or underlying severe psychosocial problems may be obstacles, even for these treatment plans. As in younger patients, trimodal therapy with bladder preservation may be an option for selected older individuals with bladder cancer (see Chapter 3). It is an aggressive treatment approach that involves radiation therapy, chemotherapy, and surgery. If an older person is too frail to undergo radical cystectomy, he or she is usually too frail to get trimodal therapy. There are a few exceptions to this general rule, and it is essential that you weigh all of the risks and benefits with your multidisciplinary care team. In frail patients, radiation therapy is sometimes used to control the symptoms of bladder cancer, but it is rarely curative.

The fatigue that usually accompanies radiation therapy can be quite profound in the elderly, even in those who are fit. Often, the logistical details (like daily travel to the hospi­tal for a 6-week course of treatment) are the hardest for older people. It is important that you discuss these potential problems with your family and social worker before starting radiation therapy. Anemia (low red blood cell count) is common in the elderly, especially the frail elderly. It decreases the effectiveness of chemotherapy and often causes fatigue, falls, cognitive decline (for example, dementia, disorientation or confusion), and heart problems. Therefore it is essential that anemia be recognized and corrected with red blood cell transfusions or the appropriate use of erythropoiesis-stimulating agents.

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Kidney function declines as we age. Some of the medicines that older patients take to treat both their cancer (for example, cisplatin, carboplatin, methotrexate, zoledronic acid, nonsteroidal anti-inflammatory drugs) and noncancer- related problems might make this worse. The dehydration that often accompanies cancer and its treatment can put additional stress on the kidneys. Fortunately, it is often possible to minimize these effects by carefully selecting and dosing appropriate drugs, managing “polypharmacy,” and preventing dehydration. Fatigue is a near universal complaint of older cancer patients. It is particularly a problem for those who are socially isolated or depend on others to help them with activities of daily living. It is not necessarily related to depression, but it can be. Depression is quite common in the elderly. In contrast to younger patients who often respond to a cancer diagnosis with anxiety, depression is the more common disorder in older cancer patients. With proper support and medical attention, many of these patients can safely receive anticancer treatment.

fter receiving the diagnosis of cancer, many patients report that they hear very little else their doctor tells them. Although this information will be repeated and clarified over the ensuing visits with your physician, it can also be empowering to find out more information on your own. When searching for information about any healthcare topic, you should look for two criteria. First, the information should be published by a reliable source. Articles or reviews by experts are often the high­est quality resources. Second, the information should be written at an appropriate level for the reader. Very technical writing may not be appropriate for everyone, whereas some patients may want more detailed scientific information. The following resources meet these criteria, are either expert written or reviewed, and offer varying levels of scientific detail.

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Actos Lawsuit : There are two broad types of cancers in the bladder: primary and metastatic. Primary bladder cancers are those that begin in the bladder itself. Metastatic cancers are those that originated in another organ and then spread to the bladder. Other tumors can get into the bladder through the bloodstream, through the lymphatic system, or by directly extending from a nearby organ, such as the prostate or the cervix.

Cancers originating in the bladder are far more common than cancers that spread to the bladder from another loca­tion. There are several types of primary tumors. Recall that transitional cell cancer accounts for at least 90% of all bladder cancers. Transitional cell tumors can be classi­fied as (1) papillary, (2) sessile, or (3) a mix of both types. Papillary tumors look like a piece of cauliflower attached to the wall by a short stalk; sessile tumors look flat and are broad-based. Almost 70% of transitional cell tumors are papillary types, which tend to have a better prognosis than sessile tumors. Less common types of bladder can­cer include squamous cell cancer, adenocarcinoma, and urachal carcinoma.

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Squamous cell carcinoma accounts for 3% to 7% of bladder cancers in the United States; however, in Egypt it accounts for 75% of the bladder cancers. There is a parasitic infection called schistosomiasis that is very common in Egypt. Infection with this parasite strongly predisposes a person to the development of squamous cell cancer. The parasite burrows into the wall of the bladder, which chronically irritates the bladder. Over many years, this chronic irritation can lead to the devel­opment of bladder cancer, most often squamous cell cancer. Other conditions that cause chronic irritation also predispose to this type of tumor. Chronic indwelling catheters, for example, can irritate the bladder and pre­dispose someone to this tumor. Squamous cell carci­noma does not tend to spread to the lymph nodes like transitional cell cancer does, although it does tend to spread aggressively directly through the bladder into neighboring structures. Because it is so locally aggres­sive and relatively resistant to chemotherapy or radia­tion, it usually has a worse prognosis than transitional cell cancers.

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Adenocarcinoma of the bladder is quite uncommon, accounting for approximately 2% of all bladder cancers in the United States. These tumors are also associated with chronic irritation. They tend to be high-grade aggressive tumors and are therefore usually associated with a worse prognosis. Urachal carcinoma is a specific type of adenocarci­noma of the bladder, but it is unique in that it does not originate in the lining of the bladder. These develop from the outer surface of the bladder, extending toward the inside of the bladder. They can then metastasize to the lymph nodes, the liver, lung, and bone.

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Actos Lawsuit: Pain post-op is initially treated often via the epidural catheter. Intravenous medication may be given as an alternative and switched to oral pain meds once the individual is tolerating liquids. Many physicians order a PCA (patient controlled anesthesia) in which the patient pushes a button that releases pain medication via an intravenous line into the blood stream. Maximal amounts of drug administered are carefully controlled by settings on the PCA to allow safe, effective analgesia.

During the post-o you will meet regularly with an enterostomy nurse who will teach you the mechanics of caring for an ostomy and handling the ostomy appliance.period, Gradually, your pain will diminish, strength will increase, and diet will be advanced. Drains placed intraoperatively to siphon off any excess fluids from the abdomen will be removed when no longer needed. During difficult dissection, small intestines may be inadvertently opened. These injuries are usually immediately recognized and repaired without difficulty. During removal of the bladder, the rectum may be entered. Assuming the patient has had a complete bowel prep prior to surgery, the rectum is usually readily repaired.

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During removal of the pelvic lymph nodes, entry into a major vein or artery may result in significant blood loss. Smaller, inconsequential veins or branches into larger veins are usually ligated with a suture or cauterized shut. Larger veins and arteries require repair with a fine vascular suture and needle. Troublesome bleeding can also occur during removal of the bladder and from deep in the pelvis after the bladder and prostate are removed. Bleeding is stopped through suture ligation, vascular clips, or cautery.

An abscess is a pocket of pus located deep within the body. It may form from a bowel or urine leak, and generally will require drainage since antibiotics alone may not resolve it. If percutaneous drainage (drainage through the skin) is possible, the radiologist will drain the abscess. If this is not possible, the urologist will need to open the incision or make a new incision to allow the pus to be drained. A sizable abscess will generally not be cured without proper drainage. Left untreated, an abscess can result in sepsis, a life threatening bacterial infection.

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When the bowel is reconnected after removing the section for the urinary diversion, healing may not be adequate and bowel contents may leak into the abdomen. A bowel leak often will present as a failure of the bowel to return to normal function, resulting in a distended abdomen with poor bowel sounds. Distention, ileus (poor bowel function) may occur after the bowels are working well and feeding has been going on for some time. Evaluation is usually accomplished with CT Scan and oral contrast. Immediate surgical correction may be necessary. Left untreated, a bowel leak will generally lead to an abscess or possibly a fistula (a drainage tract from the bowel which may extend out through the incision or drain). The incidence of bowel leak is increased if bowel has been exposed to prior radiation, most often from radiation used to treat prostate cancer in men and uterine cancer in women.

When a piece of bowel is separated from the intestine to create the new urinary drainage system, the remaining bowel must be reanastomosed (brought back together). This may be accomplished via sewing the bowel together or through the use of staples. Sometimes the opening of the bowel connection may be obstructed secondary to swelling. If an obstruction does not clear after a reasonable time, reoperation may be required.

During a standard radical cystectomy in the male, the fine nerves which run along the base of the prostate to the penis are severed, resulting in loss of erections (impotence). If the individual having surgery still has good erections and is sexually active, these nerves can be attempted to be saved by modifying the surgery. Saving the nerves is more difficult to do, it takes more time, and is not always successful.

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Actos Lawsuit : Bladder cancer is a malignant overgrowth of the cells of the bladder. Most commonly, the growth occurs in cells that are in the urothelium. The lining of most hollow spaces in the body is made of epithelial cells. The lining of the inside of your cheek, for instance, is an epithelial cell lining. Also, the lining of your stomach, bowels, gallbladder, and—you guessed it—the bladder is made of epithelial cells. Each organ has its own subset of epithelial cells. In the bladder, the lining cells are called transitional epithelial cells. The cancer that grows from these cells is then called transitional cell cancer; 90% to 95% of all bladder cancers are of this type. If the cancer grows from a different type of cell in the bladder, it is given a different name. Other types of uncommon cancers in the bladder include squamous cell carcinoma and adenocarcinoma (carcinoma is another word for cancer). A very rare type of bladder cancer that occurs only in children is called rhabdomyosarcoma.

It is also possible that cancer in the bladder did not begin there but spread to the bladder from somewhere else. The bladder is an uncommon place for other tumors to “seed” (or metastasize), but it does occasionally occur. Although metastases are uncommon, tumors can occa­sionally grow directly into the bladder from an adjacent organ, such as the prostate, colon, rectum, or cervix.

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Cancer is one of the major causes of death and disease throughout the world. If all types of cancer are combined, it ranks as the second leading cause of death in the United States today behind heart disease. As treatments for heart disease continue to improve, it has been esti­mated that within the next 5 to 10 years cancer will become the leading cause of death in the United States and other developed countries.

Bladder cancer is the fourth most common type of cancer in men and the eighth most common in women. The American Cancer Society estimated that in 2009, there would be about 70,980 new cases of bladder cancer diagnosed in the United States. In 2009, 14,330 deaths were expected from bladder cancer. In spite of the increased incidence of bladder cancer over the years, the rate of people dying from bladder cancer has decreased over the past 20 years.

From 1998 to 2000, the median age at diagnosis was 63 years of age. 90% of patients were 55 years of age and older at the time of diagnosis. The chance of a man developing bladder cancer at any time during his life is about 1 in 27, whereas it is 1 in 84 for a woman. Thus bladder cancer is 3 times more common in men than in women. The incidence of bladder cancer increases with age in both sexes, meaning that an older individual is more likely to acquire bladder cancer than a younger person. It is twice as common in white American men as it is in African American men and 1.5 times more common in white American women as it is in African American women. Hispanic Americans also have about half the rates of bladder cancer as do white Americans. Bladder cancer is more common in the United States and Great Britain than in Japan or Finland.

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cancer is more common in white Americans, African Americans tend to have more advanced disease when they first present to the doctor. This may be because of an underreporting of more superficial tumors, delays in diagnosis, or a tendency toward more aggressive tumors in this group. As would be expected from the tendency toward more advanced disease, 5-year survival rates are 71% for African American men versus 84% for white men, and 71% for African American women ver­sus 76% for white women.

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Actos Lawsuit : While still awake, you will be transferred onto the operating room table and secured on it. If an epidural has not already been placed, one may be inserted. You may have an additional intravenous line placed. Next, your anesthesiologist will have you breathe through a mask placed over your nose and mouth. You will be given a mixture of agents which will allow you to become relaxed. Further anesthetics will result in an unconscious state. At this time, an endotracheal tube will be passed down your windpipe to provide oxygen, which is delivered automatically by a respirator, controlled by the anesthesiologist. The anesthesiologist will continuously monitor your heart rate, blood pressure, electrocardiogram, and tissue oxygenation throughout your operation. Fluid balance may also be measured via an intravenous line passed close to your heart. Urine output will be followed. Antibiotics will be infused intravenously.

Usually, compression stockings will be secured around your legs. These stockings periodically squeeze the legs to prevent blood from becoming stagnant, lowering the risk of blood clots forming in your legs, which can occur when you lie completely motionless for extended periods of time. A nasogastric tube will be passed through your nostril down your esophagus into the stomach, draining the stomach secretions during and after the surgery. A grounding pad will be placed on your side to allow for the safe use of electric current which is used to sometimes cut tissue and often in the cauterization of small bleeding vessels to stop bleeding.

Your abdomen will be prepared for surgery by shaving any hair and prepping the skin with an antiseptic solution. Female patients will have the vagina prepped with antiseptics as well. The surgical field will then be draped with sterile towels and sheets to prevent contamination from surrounding non-sterilized areas. Your upper body may be kept warm with a warming blanket. Your surgical nurse, surgeon, and assistant will all have thoroughly cleaned their hands and arms (scrubbed) and will then don a sterile gown and gloves. Their hair will be covered with a surgical cap, and they will be wearing masks over their mouths to prevent any contamination of the sterilized surgical field.

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After transfer to the floor from the recovery room, the patient is often kept on bed rest for the rest of the day. The nasogastric tube is left in and placed to gentle suction to remove excess stomach fluids. Initially, nothing is allowed by mouth other than ice chips or sips of water. Adequate fluids and some nutrition are given via an intravenous catheter. By the following day, patients are often out of bed and sometimes walking with assistance. Sequential stockings on the lower legs are removed while ambulating, and discontinued once the individual is able to move about well. Traditionally, nasogastric tubes have been left in until the bowel activity returns (generally 3-4 days). This is generally heralded by the passing of flatus (gas) or the presence of active bowel sounds, which will be checked by your urologist with a stethoscope. Recent studies have indicated nasogastric drainage for this length of time may not be necessary and may impede normal breathing, leading to other problems. Some urologists are therefore removing the tubes earlier. Feeding is gradually introduced however, once bowel activity has returned.

The patient will be encouraged to do deep breathing exercises to prevent lung collapse. This process is generally assisted with a small device called a spirometer. If the individual has a history of lung disease or is congested post-operatively, respiratory treatments with inhaled medication may be instituted and provided by a respiratory therapist.

Pain post-op is initially treated often via the epidural catheter. Intravenous medication may be given as an alternative and switched to oral pain meds once the individual is tolerating liquids. Many physicians order a PCA (patient controlled anesthesia) in which the patient pushes a button that releases pain medication via an intravenous line into the blood stream. Maximal amounts of drug administered are carefully controlled by settings on the PCA to allow safe, effective analgesia.

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Bowel leak: When the bowel is reconnected after removing the section for the urinary diversion, healing may not be adequate and bowel contents may leak into the abdomen. A bowel leak often will present as a failure of the bowel to return to normal function, resulting in a distended abdomen with poor bowel sounds. Distention, ileus (poor bowel function) may occur after the bowels are working well and feeding has been going on for some time. Evaluation is usually accomplished with CT Scan and oral contrast. Immediate surgical correction may be necessary. Left untreated, a bowel leak will generally lead to an abscess or possibly a fistula (a drainage tract from the bowel which may extend out through the incision or drain). The incidence of bowel leak is increased if bowel has been exposed to prior radiation, most often from radiation used to treat prostate cancer in men and uterine cancer in women.

Bowel obstruction: When a piece of bowel is separated from the intestine to create the new urinary drainage system, the remaining bowel must be reanastomosed (brought back together). This may be accomplished via sewing the bowel together or through the use of staples. Sometimes the opening of the bowel connection may be obstructed secondary to swelling. If an obstruction does not clear after a reasonable time, reoperation may be required.

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Actos Lawsuit: For many years, it was believed lymph node dissection served mainly to provide prognostic information. Knowing whether nodes have cancer was valuable information which could be used to determine if chemotherapy was warranted after surgery. More recently, a number of studies have shown that doing a nodal dissection may prove to be therapeutic as well, resulting in a reduction of risk for recurrence and improvement in survival. The ureters may not be long enough to bring out to the skin surface at the same location for one drainage bag. In addition, the ureters are small and easily compressed, and therefore would be subject to obstruction when brought out directly.

Transitional cell cancer extending into the urethra of a female patient or the prostatic urethra of a male patient would generally require urethrectomy at the time of cystectomy. Urethrectomy requires more dissection, potential for bleeding and infection, and possibly increased post operative drainage. It should therefore be performed only when necessary. Cancer located close to the bladder neck may raise the odds of cancer developing in a urethra which is left behind. The status of the urethra can be followed post cystectomy with washings sent for cytology. If cancer subsequently develops, a urethrectomy can be accomplished as a separate operation long after cystectomy has been done.

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At the conclusion of surgery, generally while still in the operating room, the endotracheal tube is removed when the patient is awake enough to breathe on his own. The patient will then be brought to the recovery room where he will be carefully observed by trained nurses in conjunction with the anesthesiologist and urologist. The individual is kept in the recovery room until conscious, breathing on his own and stable. Recovery room stays may be short, on the order of 30 minutes, or may extend to several hours, depending on how the individual is doing. If doing well, the patient will then be transferred to a floor in the hospital. If the individual’s surgery was particularly complicated, extended, or if the individual is unstable (irregular heart beat, low blood pressure, inability to be taken off the respirator), or if the individual has significant medical problems or has experienced a complication from surgery, transfer to an ICU (intensive care unit) may be warranted. In the ICU, there exists a much higher ratio of nurses to patients than on a standard postoperative floor, allowing for constant surveillance and care for critical patients. Also, if a respirator is required postoperatively, initial treatment in an ICU is usually necessary.

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After transfer to the floor from the recovery room, the patient is often kept on bed rest for the rest of the day. The nasogastric tube is left in and placed to gentle suction to remove excess stomach fluids. Initially, nothing is allowed by mouth other than ice chips or sips of water. Adequate fluids and some nutrition are given via an intravenous catheter. By the following day, patients are often out of bed and sometimes walking with assistance. Sequential stockings on the lower legs are removed while ambulating, and discontinued once the individual is able to move about well. Traditionally, nasogastric tubes have been left in until the bowel activity returns (generally 3-4 days). This is generally heralded by the passing of flatus (gas) or the presence of active bowel sounds, which will be checked by your urologist with a stethoscope. Recent studies have indicated nasogastric drainage for this length of time may not be necessary and may impede normal breathing, leading to other problems. Some urologists are therefore removing the tubes earlier. Feeding is gradually introduced however, once bowel activity has returned.

Our use of the term or terms Actos Lawsuit is for descriptive purposes only. There is no relationship between the owners of this website and the maker of the product discussed in this post. Our use of the words Recall, Class Action Lawsuit and other similar words related to an event do not necessarily mean that this event has occurred. Refer to the website of the United States Food and Drug Administration for information on drug or medical device recalls. If a Class Action Lawsuit is formed in relation to the product discussed in this post we will provide that information at the time the Class Action is formed. A Class Action Lawsuit is not required to exist for you to file a lawsuit if you have been injured by the product discussed in this post.

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Actos Lawsuit : After bladder removal surgery, you will first become accustomed to your stoma, and the mechanics of keeping your collection appliance in place. The stoma is composed of the end of ileal loop (urostomy) which is brought out through the skin and everted (folded back) and secured to the skin. The location of the future stoma is usually determined prior to surgery. Ideally, it will be below your “belt line,” and definitely away from any skin indentations which can occur from body fat or scars. The stoma is red in appearance, moist, and has no sensation when you touch it. It measures approximately 1-1 Vz inches across and has been described as looking like a “rosebud.” It will be the only visible manifestation of your ileal loop diversion.

Getting used to a urostomy takes time. One must overcome issues with altered body image. Real izing the removal of your bladder was necessary to preserve your life, most individuals readily accept the urostomy and its care as the price for surviving and getting on with living.

The next step is to learn how to care for it and the collection appliance. Many individuals now use a collection bag which fits directly over the urostomy with the base of the bag adherent to the surrounding skin, accomplished with a hypoallergenic adhesive. Care of the urostomy can be as simple as gently washing the skin around the stoma and then applying the adhesive bag. A seal can last around four days. Once the seal is deficient, a new bag is applied. Most collection bags snap 011 and off the underling adhesive base, which makes changing a bag possible without removing the adhesive seal. Depending on your urostomy and your preferences, your enterostomy nurse will work with you to figure out which device works best for you. Some individuals benefit by having an elastic strap secured to the bag and around their waist. Separate stretch belts are also available to help keep the ostomy bag in place.

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During the day time, the urine drains directly into the bag attached over the stoma. Bags can either be transparent or opaque. Depending on bow much fluid you are drinking and how physically active you are, the bag may need to be drained approximately every four hours. Emptying the bag is accomplished easily by opening the drainage port and allowing the urine to empty directly into a toilet. If you don’t want to bother getting up in the middle of the night to drain the bag, the collection bag can be drained via a tube to a larger capacity bed side bag. This bag can be disconnected in the morning from the collection pouch.

Immediately after formation of an ileal loop, there may be much sediment in the urine. This material is a by product of the ileal loop surface lining. Over time, this sediment decreases and with good hydration, the urine takes on a normal appearance. A urostomy and its collection bag are not apparent under someone’s clothing. Usually there is minimal or no odor. An individual with a urostomy can continue to enjoy all physical activities.

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The actual surgery to form the continent diversion may take several hours more to accomplish compared to an ilea) loop. This additional surgical time is not a problem as long as the individual is in good health, and the surgery has gone well. Not all urologists do continent diversions on a regular basis. If a urologist does not do this operation regularly, you will be better off finding a urologist that does, since complications related to this part of the surgery will be increased by inexperience. Because different techniques exist and the level of expertise and experience of each urologist is different, it is important to ask the urologist about the complications that may occur and the general frequency of occurrence he has seen in his patients. Complications unique to this diversion as compared to the ileal loop may occur, requiring reoperation in up to 20% of patients. If the complication rate is unacceptable, consider an ileal loop. The most common complications are:

Difficulty with catheterization: After the surgery the pouch may become increasingly difficult to empty. Surgical reconstruction is mandatory if a pouch cannot be readily emptied. Incontinence: During surgery, the continence mechanism is checked. However, at some time after surgery, incontinence may occur, necessitating the wearing of a collection device. In addition, the pouch may still need to be catheterized. Surgical reconstruction is required to reformat the continence mechanism.

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Actos Lawsuit : If you should have a recurrence of superficial urothelial cancer, there is a greater than 50 percent chance that it will happen in the first year after treatment. And there is up to a 30 percent chance that a recurrence will have progressed to a higher, more invasive, stage of the disease.

The stage, grade, and type of your cancer will strongly influence treatment options. (These will be discussed in the next two chapters.) They also are clues to whether your cancer might be aggressive, whether you might have a relapse or recurrence after treatment, and how hopeful the outlook is for a cure.

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If your doctor tells you that you have bladder cancer, what you talk about next depends upon the answers to two questions:

What kind of bladder cancer do I have?

Expect your doctor to tell you whether your cancer is urothelial or transitional cell cancer, squamous cell, adenocarcinoma, or a rarer form of cancer, and to give you a general explanation of how the type of cancer you have generally behaves, including whether your type of cancer often recurs, metastasizes, or is considered highly treatable.

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What stage and grade is my tumor, and what does that mean?

Your doctor is likely to categorize your cancer with a letter, numeral, and stage-—-perhaps something like “T2aNlM0 Stage I”-—and will explain what those symbols mean by describing how deeply the cancer has invaded your body, how abnormal the tumor cells are, and whether the cancer has spread.

When you are comfortable with the answers to your questions, you will be ready to talk about treatment options and your treatment team. You 11 want to know who will be on it, what part each team member will play in your care, and who will serve as your contact point for questions or concerns.

Our use of the term or terms Actos Lawsuit is for descriptive purposes only.  There is no relationship between the owners of this website and the maker of the product discussed in this post.  Our use of the words Recall, Class Action Lawsuit and other similar words related to an event do not necessarily mean that this event has occurred.  Refer to the website of the United States Food and Drug Administration for information on drug or medical device recalls.  If a Class Action Lawsuit is formed in relation to the product discussed in this post we will provide that information at the time the Class Action is formed. A Class Action Lawsuit is not required to exist for you to file a lawsuit if you have been injured by the product discussed in this post.

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Actos Lawsuit : To Help You Talk about Cancer

• The National Cancer Institute offers articles such as “What It’s Like for You” and “Taking Time: Support for People with Cancer” at its website (www.cancer.gov). You can also call 800-422-6237 (800-4-CANCER) to find out about available publications and brochures,

♦ The American Cancer Society offers a number of articles on coping with cancer, including “Helping Children When a Family Member Has Cancer” and “Talking with Children about Cancer” at www.cancer.org. You can also call 800227-2345 (800-ACS-2345) for information on ordering.

(continued)

• The Cancer Survivors Network is a forum or message board at the American Cancer Society website (www.cancer.org) where people can ask questions and share information and. resources with other people who are dealing with cancer.
• Your hospital’s social work department will have counseling and resources available for you and your family. Just ask your doctor to put you in touch with the appropriate office.

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• When possible, couch discussions in hopeful and reassuring words by telling your loved ones that you feel positive about your treatment.
• When talking about cancer with children, keep information age-appropriate. The National Cancer Institute offers a guide called Tips for Talking with Children of Different Ages, which you can obtain at www. cancer, gov.
• With your family members, agree to give each other permission to feel stressed or worried or angry—or even happy—without feeling guilty.
• Acknowledge that there may be tough times ahead, but recognize that caring and love will help get you through them.
• Acknowledge that things will change. Talk about changes as they occur.
• Talk often with family and loved ones. Speak from your heart.
• Expect lots of questions. Expect some disagreements. Expect times when you wish that things could go back to the way they were before you had cancer. And expect deeply meaningful moments with the people you love most.

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Actos Lawsuit : On rare occasions, doctors will recommend another resection procedure. Sometimes the pathologist wants to biopsy muscle tissue from deeper in the bladder wall. And sometimes the tumor is too large to be safely removed all at once.

Sometimes, in an alternative procedure, lasers (high- energy light beams) are used to remove superficial tumors. While patients find this procedure slightly more comfortable than resection, the laser often destroys the tumor tissue, leaving nothing for pathologists to examine. The lack of pathology may limit your medical teams ability to predict recurrence and target your follow-up plan.

If you have been diagnosed with a low-risk tumor, resection may be the only treatment recommended by your medical team. Your team may also recommend a course of intravesical therapy.

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When you have a bladder resection by means of a cystoscopy, as opposed to invasive surgery, you wont have an incision or stitches, as no external cutting or incision is required.

Resecting (sometimes called endoscopic resection) is performed under general anesthesia in a hospital setting. Your doctor will use a resectoscope, which resembles a somewhat larger cystoscope. Like a cystoscope, a resectoscope has a lighted lens and is introduced into your bladder through your urethra. (Don’t worry; you will be asleep under anesthesia and receiving pain medication while this is happening.)

Your doctor will fill your bladder with water or a nonirritating clear liquid such as glycine, which expands the bladder walls and makes it easier to see tumors and abnormalities. Guided by the map made during the initial cystoscopy, your doctor will use a small wire loop (through which a high-energy electrical current runs) to remove the cancer, a margin of healthy tissue, and a small amount of muscle. Any remaining cells are removed with an electric current or sometimes a high-powered laser. Sometimes your doctor will also take a few random tissue samples from other areas of your bladder to make sure abnormal cells are not developing elsewhere. The tumor, healthy tissue, and muscle are then sent to your pathologist for examination.

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A small amount of muscle tissue is included in the tissue sample so the pathologist can verify that the tumor has not spread into the muscle wall. A margin of healthy tissue is removed to decrease the chances that abnormal cells remain in the bladder.

Resection is usually carried out as outpatient surgery. This means that you probably will be able to go home the same day. (You will need a driver to accompany you because you will still be recovering from anesthesia when you are released from the hospital, so you wont be sufficiently alert to drive a car.) You may see some blood in your urine for a few days after a resection, and you may experience pain or stinging when you urinate. The stinging can be eased by drinking lots of fluids and by taking simple pain medications prescribed by your urologist. If either condition lingers longer than two or three days, if other painful conditions occur, or if the bleeding becomes extensive, call your doctor right away.

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Actos Lawsuit: Phase I trials study how to administer a new drug or treat­ment and how much of the drug or treatment can be safely tolerated. The drugs or treatment in a phase I trial have been extensively tested in a lab and in animal studies, but not in humans. If a drug is being rested, researchers may start by giving a very low dose of the drug to those participating in the trial, then increase it gradually to derermine when side effects appear and what dosage is tolerable, yet effec­tive. Phase I trials usually enroll a small number of people at a limited number of locations. In general, they are the least likely to be of direct personal benefit to a patient, as the drugs are less well known, but occasionally they can lead to significant tumor shrinkage with side effects well within the tolerable range.

Phase II trials take the studies a step farther. From the phase I results, researchers know what dosage to give with a good margin of safety; in phase II they are ready to test whether the drug really works as well as anticipated. They carefully monitor patients in the study for side effects and observe closely how the drug affects the cancer. A phase II study usually targets a particular disease or type of cancer and includes fewer than 100 people.

Phase III trials involve large groups of people across a broad geographical area. A random process determines which indi­viduals will receive the drug being tested and which ones will receive standard treatment. The idea is to compare accurately whether the new treatment is better than the old treatment and whether there are different patterns of side effects and survival. The results are monitored closely, and if one treat­ment is observed to be significantly more effective than the other, the trial is stopped. Sometimes a phase III trial will find that the new treatment is not better than the standard, in which case the new treatment is usually dropped from the list. Studies are randomized—patients are chosen randomly for the new and standard treatments—to avoid introducing biases into the study. For example, without randomization, there might be an inadvertent tendency to choose younger and stronger patients for the new agent and older patients with other medical problems for the established treatment. This might make the new treatment appear to be better than the established treatment when, in fact, the differences were attributable only to the type of patient receiving each type of treatment. In some cases, where the benefits of a new drug are really uncertain, and it is not clear whether the new drug is better than no treatment at all, a phase III trial will compare the new drug to a placebo (an inactive agent). This is done to exclude the possibility of patients experiencing perceived benefit just because they are receiving treatment itself, rather than because the drug is actually reducing the cancer. As surprising as it seems, this effect (known as the placebo effect) really does occur occasionally. Doctors are required by law to inform patients if they are using a pla­cebo in such a trial.

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A document called an informed consentWiW help you sort through your questions and concerns. The form, which you sign, includes a disclosure statement from the researcher describing the protocol, who is conducting the trial, what tests will be made and how, the possible risks and the pos­sible benefits to you, and what side effects are anticipated. Informed consent gives you information you need to make a decision about participating in a clinical trial. An informed consent states that you agree to participate in the clinical trial and requires your signature.

Signing an informed consent form does not mean that you are legally bound in any way to remain in the clinical trial. You may drop out at any time. Before the trial starts, after it’s under way, during the follow-up period—anytime. Informed consent doesn’t end once the clinical trial has begun. Researchers are obligated to tell you if they find new side effects, benefits, or risks to participating in the study.

You have decided to participate in a phase III clinical trial in which a new drug is being tested by a research team. Who pays for it? Your usual care costs—those you would incur whether you are enrolled in a trial or not—are usually covered by your insurance plan or Medicare. But the extra care costs that are incurred by your par­ticipation in a clinical trial may not be covered. Often if a drug is being tested, it is provided to trial participants free of charge. But you may have a side effect, such as nausea, and require an antinausea prescription to address the com­plaint. Your insurance company may view the antinausea medication as an extra care cost. The clinical trial may or may not pay for the antinausea drugs or other office visits or tests specifically required as part of your being in the trial. Sometimes federal funding or grant programs help pay the costs; sometimes they don’t.

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Sadly, your insurance company may or may not agree to pay costs for expenses associated with the clinical trials. Some insurance companies consider such treatment experimental and, as such, refuse to pay. Before you agree to participate in a study, contact your insurance company to determine what your plan covers. Some states have passed legislation requir­ing insurance companies to cover the costs to patients of clin­ical trials. Federal health insurance, for the most part, covers clinical trials. Medicare does, for example, and so does healch insurance through the Department of Veterans Affairs and the Department of Defense. Things change, however, and you should double-check your coverage before going ahead with a clinical trial. If your insurance company does not cover clinical trial expenses and you want to participate, ask someone from your medical team or the clinical trial team to contact a representative from your insurance company. Sometimes after claims representatives review the clinical trial proto­col, they will approve payment. Also, the National Cancer Institute is working with many health-insurance and man- aged-care providers to find answers to the question of how to provide coverage for clinical trial participation.

After a clinical trial is over, the results are often pub­lished in medical magazines or scientific journals. Once a new drug or treatment has been deemed effective and safe, it becomes standard practice; this means that doctors accept and use the drug or treatment while providing everyday medical care.

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Actos Lawsuit:  The bladder contains a number of layers, with muscle making up the deep layers and the bladder lining constituting the top layers. Up to 70 percent of bladder tumors are non-muscle-invasive at the time of initial presentation and may not represent life threatening disease. However, approximately 50-90 percent of noninvasive cancers will recur within 5 years of diagnosis and initial treatment. The likelihood of recurrence increases for patients who have high-grade tumors, large tumors, multiple tumors, flat tumors (versus tumors that grow on a stalk), or tumors that appear to invade small vessels that transport blood or lymphatic fluid. For that reason patients who have bladder cancer are monitored very closely and on a regular basis.

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For many patients, knowing that bladder cancer is likely to recur can be associated with great anxiety. However, most of these recurrences can be managed with further trans­urethral surgery (resection of the tumors via cystoscope) or intravesical chemotherapy (medication placed inside the bladder) such as mitomycin C or bacillus Calmette-Guerin (BCG) therapy. For patients with low-grade (less aggressive) disease, 5-10 percent will progress to worse (or invasive) disease when they recur. For patients with high-grade bladder cancer (the more aggressive type), 15-50 percent will progress to invasive disease and 10-25 percent will die of bladder cancer. For this reason it is of the utmost importance for patients with high-grade bladder cancer to be monitored very closely.

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Most urologists check urine cytology and perform flexible cystoscopy 3 months after the fteatment for an initial diagnosis of bladder cancer. The timing of the initial check and subsequent follow-up depends on a number of factors. Intervals are usually 3-6 months and vary depending on whether the patient has low- or high-grade bladder cancer, if they received intravesical treatment, and the level of concern about recurrence based on the patient’s risk factors and appearance of the first tumor. In general, patients with low-grade tumors are watched every 3-6 months for several years after initial diagnosis. Patients with high-grade tumors are followed with cytology and cystoscopy every 3 months for 2 years, then every 6 months for 2 years, and then annually thereafter is typically recommended. It is also suggested that the upper urinary tract (kidneys and ureters) are imaged (by x-ray, CT, or MRI) every 1-2 years to ensure that the tumors do not recur elsewhere in the urinary tract (outside of the bladder).

If chemotherapy was used first, BCG should be used as the second agent. If BCG was used initially, a second course of BCG can be repeated or BCG + interferon can be used as intravesical therapy. However, approximately So percent of patients who receive two courses of intravesical treatment will not have their bladder cancer controlled by medication alone. Therefore if a patient continues to recur despite continued resections and intravesical treatments, especially if they have high-grade disease, the risk of invasive disease continues to rise and they should consider cystectomy, which is surgical removal of the bladder. If they are unable or do not wish to undergo surgery, there are alternative therapies, including chemotherapy or radiation therapy These therapies do not often control cancer as well as surgical removal of the bladder. If a patient recurs and the cancer has spread outside of the bladder, either by invading odier organs in the pelvis or spreading to lymph nodes, there remain effective treatments to control the cancer. Options include surgery (cystectomy) in combina­tion with chemotherapy and/or radiation.

Our use of the term or terms Actos Lawsuit is for descriptive purposes only. There is no relationship between the owners of this website and the maker of the product discussed in this post. Our use of the words Recall, Class Action Lawsuit and other similar words related to an event do not necessarily mean that this event has occurred. Refer to the website of the United States Food and Drug Administration for information on drug or medical device recalls. If a Class Action Lawsuit is formed in relation to the product discussed in this post we will provide that information at the time the Class Action is formed. A Class Action Lawsuit is not required to exist for you to file a lawsuit if you have been injured by the product discussed in this post.

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Actos Lawsuit: A clinical trial may include fewer than 100 people moni­tored at just one or two locations, or it can involve thou­sands of people monitored by many doctors, nurses, data collectors, and other researchers at diverse locations such as doctors’ offices, hospitals, clinics, or medical centers. Clinical trials are sponsored by government agencies such as the National Cancer Institute, as well as medical institutions, individual doctors or other medical personnel, medical foundations, and drug companies or companies that manufacture diagnostic testing equipment. You may be alarmed if your doctor suggests the possi­bility of participating in a clinical trial. Does it mean that you have no hope? What should you do? How should you respond?

It is important not to dismiss the idea out of hand. The words experimental, research, and human volunteer can be upsetting, particularly at a time when you are dealing with the emotional issues surrounding a diagnosis of advanced cancer. But treatments in clinical trials can often be highly beneficial to the patients who volunteer. You and your loved ones should talk with your medical team members about the clinical trial they are recommending and why it may benefit you. Noteworthy to many patients is that several studies have documented that patients who participate in clinical trials have better outcomes than those found in the community at large. However, this also may also be due to the types of patients who agree to participate in trials.

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Does referral to a clinical trial mean that there is no hope of your surviving this illness? Not at all! There is always hope of survival, and any doctor can tell you about people who have responded positively to treatment and not only sur­vived, but thrived. Participating in a clinical trial doesn’t mean that you wont continue to receive medical treatment; you will, and since the trial is a voluntary process, you have the right to stop participating in the trial at any time. As with any aspect of your treatment plan, you’ make the decision about whether to proceed. Don’t feel pressured to participate in a trial if it doesn’t feel right for you, but do give it objective thought and consideration.

As with any treatment, you should ask about possible risks, benefits, and side effects, how the treatment works, and what results doctors expect from the study. You will want to know who is conducting the clinical trial and what kind of oversight is in place. Also ask what is expected of you. Where will you go for the treatments? How often will you go? Are there more tests or office visits than you might have with standard treatment? Who administers the treat­ments and how are the results measured? Do you have to report regularly to the people who are conducting the trial? Who pays for it all? Will there be extra costs to you as a result of your participation? Will the team conducting the trial (or the doctors involved) stand to benefit personally from the results of the trial or its conduct?

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There are many kinds of clinical trials. Some test preven­tion, such as whether vitamin C prevents colds. Some test whether particular screening tests, such as mammograms for breast cancer, are effective. The clinical trials your team is likely to mention are treatment trials, whereby a new drug, a new treatment, or even a new way of applying a standard treatment will be examined and tested. Each treatment trial will have a very detailed and spe­cific plan called a protocol. Think of a protocol as a recipe or instructions that describe what will be done in the trial, why the trial is necessary, who is eligible to participate, and how it will be conducted. Any doctor or researcher who takes part in die trial uses the trial’s protocol to ensure consistent results and to make sure that the new drug or treatment is given properly and with maximum safety.

Within treatment trials, there are four categories, or phases. You should ask the members of your medical team which phase of clinical trial they are recommending to you and find out specific details about the trial, such as the num­ber of people involved, where the testing is being done, what benefits or drawbacks are expected for you personally, and how long the trial is expected to last.

Our use of the term or terms Actos Lawsuit is for descriptive purposes only. There is no relationship between the owners of this website and the maker of the product discussed in this post. Our use of the words Recall, Class Action Lawsuit and other similar words related to an event do not necessarily mean that this event has occurred. Refer to the website of the United States Food and Drug Administration for information on drug or medical device recalls. If a Class Action Lawsuit is formed in relation to the product discussed in this post we will provide that information at the time the Class Action is formed. A Class Action Lawsuit is not required to exist for you to file a lawsuit if you have been injured by the product discussed in this post.

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