View clinical trials related to Urinary Bladder, Overactive.
Filter by:The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.
This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined with YM178.
The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.
The specific aim of this study is to evaluate the safety and efficacy of each of 2 dosages of BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been adequately managed with anticholinergic therapy.
The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.
Urethral dilatation is a commonly undertaken intervention for a variety of urinary complaints including overactive bladder symptoms. There is however very little evidence for its efficacy, and no randomized trial evidence. The aim of this study is to ascertain the effect of urethral dilatation on overactive bladder symptoms and on voiding parameters. The null hypothesis is that there will be no difference in symptoms or voiding parameters between the urethral dilatation and sham groups. Eligible women will be assessed initially with a history and examination, a King's Health Questionnaire and Bristol Female Urinary Tract Symptoms (BFLUTS) questionnaire and pressure flow studies. They will be randomized to undergo either cystoscopy alone or cystoscopy and urethral dilatation. Patients will be blinded to the procedure undertaken and randomized using a series of opaque envelopes. Follow up will be at 6 weeks with repeat questionnaires and pressure flow studies. Subjective and objective outcomes will be compared between the two groups.
For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB concluded that the drugs provide significant improvements in OAB symptoms compared with placebo but that the benefits are of limited clinical significance. The analysis questioned the clinical significance of the trial results, one reason for which was the lack of data on the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures of treatment success may be meaningful to clinicians but often have little meaning to patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun to recognize the value of PROs but still overlook the treatment efficacy in terms of patient-reported goal achievement (PGA). Patients with OAB have combination of symptoms and the extent to which individual OAB symptoms affect patients varies. Also each patient can have different goal for the treatment. Therefore, assessing the degree of goal achievement in each patient can provide a new aspect of treatment benefit. This controlled study will advance the understanding of OAB in terms of patient-centered treatments goals and goal achievement and will provide a new aspect of treatment benefit.
Importance of the problem OAB is a common health problem. Milsom et al. [1] randomly selected a population from six European countries. From this population, 17% of the respondents reported having OAB symptoms with 14% reporting frequency, 9% urgency, and 6% urge incontinence. The study by Milsom et al. [1] showed that OAB adversely affected the lives of the majority (65%) of the respondents who reported OAB symptoms. Chen et al. [2] also reported that the prevalence of OAB in Taiwanese women was similar to that of Western women. In the study of Chen et al.[2], the prevalence of OAB was 18.6% for the patients; perceptions and the number of OAB condition significantly increased in the elderly women (over 65 years old, 39.3%). Apart from impairing the physical health, OAB may have a tremendous effect on psychological and social well-being. Information on the symptoms and disease severity can yield important information that often complements objective measures. Incontinence, increased urge and increased frequency of micturition affect nearly 100 million people in the western world (33 million in the US and 66 million in the European Union). These conditions are not life threatening but they seriously affect quality of life and ability to work. OAB is in some studies reported to have an incidence of up to 17 % in the western population with great consequences for the quality of life. Economic cost The total economic cost of this group of conditions is high. In 2002 the costs in the US were approximately $12.7 billion[1] (estimated to be $17 billion and €22 billion/year in 2005). Approximately 25% of this expenditure is spent on treatment (drug therapy, clinical consultation and surgery). Of those who suffer only 28% have sought help and only half of those currently receive treatment. Less than 3% regain long lasting normal control. Therefore, these costs are an under-estimate and the problem is large. Aetiology
This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.
To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil