This trial is evaluating whether Exparel 133 MG Per 10 ML Injection will improve 2 primary outcomes and 3 secondary outcomes in patients with Urologic Diseases. Measurement will happen over the course of 10-14 days postoperatively.
This trial requires 200 total participants across 2 different treatment groups
This trial involves 2 different treatments. Exparel 133 MG Per 10 ML Injection is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
Most urologic diseases requiring treatment are benign and can be successfully managed with only medical care. Common treatments for a variety of urologic diseases include medications, surgery, chemotherapy, radiation, or a combination of these.
At this time, it is impossible to cure urologic diseases by pharmacologic treatment alone. However, many urologic symptoms can be much decreased with pharmacologic remedies and procedures. A combination of medication and surgery may achieve the best results and reduce the adverse effects of those treatments.
The symptoms for the urologic diseases may be similar in all patients; some of them might lead to the erroneous diagnosis of benign pathology resulting in missed treatment of patients. Recent findings provides useful clues for diagnosis and treatment of benign urologic diseases.
Almost 8.5 million people develop renal disease and nearly 6.5 million people develop a urologic disorder. In both estimates, a significant portion of the cases will develop end-stage renal or urologic disease.
For many patients, medical symptoms are the only clinical clue that a neurological disease may be present. However, in about 10% of patients, a medical history is not adequate to make a firm diagnosis of a neurological disease, and a neurological examination is needed. In this setting, it is helpful to perform a neurological examination when the clinical history raises suspicion for a neurological disorder. These signs include changes in visual acuity and aphasia. \nClinical exam: \nChanges in the sight are the chief sign of neural damage. Loss of vision may be sudden or gradual and involve both eyes. Any sudden loss of sight should prompt thorough CNS evaluation. \nUnexplained visual loss should be investigated immediately.
The treatment of interstitial cystitis (IRs) with a single intravesical injection of saline solution followed by instillation of a 1:1 mixture of 1% bupivacaine with distilled water for 60 seconds can be an effective, fast-approaching, and safe intervention for IRs.
Many medications and clinical applications remain in the preliminary phases of testing. A number of newer treatments for urologic conditions are in development, including a new agent in development for patients with refractory fistulae. Another promising new drug is the antiangiogenesis drug, Sutent. Clinical trials for other drugs, such as bortezomib (Velcade), may help stop tumor growth in a number of patients. There are also new studies and therapies for treating some urinary and/or urogenital cancers (e.g., bladder cancer, prostate cancer).
Today's medicine for treating and preventing urologic diseases is new and exciting. There is a lot of new information about urologic diseases, surgical options, and treatments currently being formulated into clinical trials. Most new developments are aimed at improving patient outcomes as well as providing more choices to patients and doctors.
Exparel 133 mg per 10 ml injection was well tolerated with no clinically significant increase in pain scores or an adverse change in continence scores. These data support the use of periurethral injection of 0.1 mL of 0.25% bupivacaine for urologic interventions that are otherwise painful.
There is no clear evidence that the addition of 0.33 micrograms of levobupivacaine per 10 ml increases the duration of procedural benefits that are attained with bupivacaine alone. On the other hand, the addition of levobupivacaine to the peri-operative dose of 1,8 mg per kg. is not associated with significant reductions in postoperative opioid requirements.
[Menstrual disorder was reported by 32% of the patients with LUTS. Other urologic disorders were the source of [prostatitis] (13%), urethral stricture (12%), and chronic pelvic pain syndrome (11%). Urologic diseases can be divided into two groups, [benign disorders] (mainly LUTS [25%]) and serious disorders (prostatitis [14%], urethral strictures [14%], [infectious urethral disease] [14%], chronic pelvic pain syndrome [14%]). The [benign bladder disorders] were associated with the highest frequency of LUTS (55%).