Active clinical trials for "Urinary Bladder, Overactive"

This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.

The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

Bladder carcinoma is the most common malignancy of the urinary tract. Approximately 75-85% of patients with bladder cancer present with a disease that is confined to the mucosa or submucosa. These categories are grouped as non-muscle-invasive bladder tumors(i.e. superficial tumors). Bladder cancer is the fifth most common cancer in the United States, with an estimated 67,160 newly diagnosed cases and 13,750 deaths in the United States in 2007. The 5-year survival rate is 82% for all stages combined. The standard of treatment for patients with superficial bladder cancer is surgical transurethal resection (TUR) of tumors, with an 80% early success rate. However, nearly 70% of these patients will develop tumor recurrence, with 25% showing progression to muscle-invading disease, within 5 years with TUR. It is therefore necessary to consider adjuvant therapy in all patients. The absolute risks of recurrence and progression do not always indicate the risk at which a certain therapy is optimal. The choice of therapy may be considered differently according to what risk is acceptable for the individual patient and the urologist. Intravesical chemotherapy and immunotherapy are widely used as adjuvant therapies after TUR, to prevent recurrence and progression of superficial disease. Systemic therapy is typically reserved for higher stage, muscle-invading, or metastatic diseases. The urinary bladder is an ideal organ for regional therapy. The urethra provides easy access of therapeutic agents to the urinary bladder. The presence of the specialized asymmetric unit membrane on the urothelium serves as a barrier and limits the absorption of molecules or particulates into the systemic circulation. The rationale for intravesical therapy is to maximize the exposure of tumors located in the bladder cavity to therapeutics agents while limiting the systemic exposure and thereby limiting the host toxicities; the primary goal is to eradicate existing or residual tumors through direct cytoablation or immunostimulation. The unique properties of the urinary bladder render it a fertile ground for evaluating novel approaches to regional therapy, including local hyperthermia, co-administration of permeation enhancers, bioadhesive carriers, and gene therapy. One of the developing treatments for high-risk superficial bladder cancers is the combination of intravesical chemotherapy and hyperthermia (HT), called chemohyperthermia (C-HT). The most common form of C-HT uses the Synergo HT system, in which local HT is administered via direct microwave irradiation of the urothelium by means of a 915-MHz intravesical microwave applicator. The target intravesical temperature is set between 41.8C and 44.8C and is measured by five thermocouples integrated in a 20-F treatment catheter. To avoid injury, the urethra is continuously cooled. Due to extensive global experience with its use and a significant amount of preclinical data demonstrating improved antineoplastic efficacy when heated, mitomycin C (MMC) is the most common intravesical chemotherapy agent used in conjunction with HT. The most common adverse events during treatment were bladder spasms and bladder pain. Literature reports bladder spasms in 21.6% of patients, and bladder pain in 17.5%. Bladder spasms tended to occur more frequently with the prophylactic schedule, whereas pain was present equally in the prophylactic and ablative schedules but more commonly after the ablative schedule. In the first days following C-HT, storage LUTS (frequency, dysuria, urgency, nocturia) (25.6%) and hematuria (6.0%) are the most common adverse events. Most studies mention that these symptoms were mild and transient, resolving spontaneously within a few days of treatment. One study described severe cystitis complaints in three patients (16%), but other studies have not confirmed these adverse events. Two studies report the development of a contracted bladder and severe urinary incontinence after ablative C-HT. However, the possibility cannot be excluded that previous transurethral resection and intravesical chemotherapy might have contributed to this event. Following the appearance of bothersome storage LUTS, patient should be managed by existing guidelines. Based on AUA/SUFU Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults Guidelines published in 2012 patients should be diagnosed, followed and treated according to the suggested algorithm. In our study, we would like to assess the severity of OAB symptoms and their response to a standard OAB treatment according to AUA Guidelines for Non-neurogenic OAB as well as to assess urodynamic study variables in those who didn't respond to a standard medical treatment and bothered by their OAB symptoms.

The purpose of this study is to document the safety, the effectiveness, the continued performance at mid and long term, the morbidity and the percent of surgical revisions of the Interstim® therapy for up to 5 years in a representative sample of French centers under real-life conditions of use.

In the last years, botulinum toxin type A (onab/A) has been increasingly used as a treatment option for overactive bladder symptoms in patients affected by either neurogenic and idiopathic detrusor overactivity (DO). How onab/A injected into the detrusor muscle improves overactive bladder symptoms in neurologic patients has been only partially investigated.Some evidence suggested that the neurotoxin probably reduces detrusor muscle contraction blocking detrusor muscle cholinergic innervation. However, recent experimental observations indicated that onab/A determines more complex effects on bladder activity acting on afferent innervations as well as on the efferent one. Only few experimental studies have investigated the activity of onab/A on bladder afferent nervous transmission. Experimental studies in animals showed that Nerve Growth Factor (NGF) elicits increased sensation, urgency and DO. Although there are some evidence on the ability of onab/A to improve DO and to reduce bladder and urinary content of NGF, how onab/A influences NGF expression and the expression of TrKa, p75 and TRPV1 receptors is still unclear. The hypothesis is that onab/A reduces NGF bladder tissue levels and in the same time it modulates the gene expression of NGF associated receptors (TrkA, p75 and TRPV1).

Over the past few years it has become clear that our understanding of bladder physiology is inadequate to explain urge incontinence. This has forced us to re-evaluate what we know and do not know about bladder function and dysfunction. This has led to the identification and study of novel systems within the bladder that may contribute to abnormal sensations. The investigators now suspect that the organic changes occurring in the bladder are not the whole story. For one group of patients with pathological urge there is growing evidence suggesting that there may be a strong psychological component. The idea now being put forward is that normal afferent peripheral information is perceived as abnormal and excessive, resulting in an increased desire to go to the bathroom: 'perceptual urge'. It is important to identify this group of patients since it will direct their treatment towards more cognitive approaches. Also, if such a psychological aetiology can be eliminated it would lead to a more focused and effective management of peripheral pathology with surgery or pharmacology.

The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.

Patient perspective on Overactive Bladder and symptoms experienced after administration of Darifenacin

The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

A study to understand the impact of Betmiga® on patients quality of life, satisfaction with treatment, how long patients remain on treatment, patterns of healthcare resource utilisation, and safety as prescribed by the physicians in routine clinical practice.