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Urinary Bladder, Overactive clinical trials

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NCT ID: NCT01936870 Completed - Clinical trials for Overactive Bladder (OAB)

Drug Use Investigation for Toviaz

Start date: October 1, 2013
Phase:
Study type: Observational

The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.

NCT ID: NCT01933074 Completed - Overactive Bladder Clinical Trials

Clinical and Biochemical Evidence of Neurogenic Inflammation in Women With Urinary Urgency

Start date: January 2013
Phase: N/A
Study type: Observational

The purpose of this study is to gain a better understanding of what causes urinary urgency in women by asking about different symptoms and measuring biomarker levels in their urine. Understanding the underlying causes of urinary urgency will allow us to develop treatment options to better take care of women with urinary urgency.

NCT ID: NCT01925456 Completed - Overactive Bladder Clinical Trials

Validation of Instruments for Pragmatic Clinical Trials for Overactive Bladder

PfizerOABLUT
Start date: May 2011
Phase: Phase 1
Study type: Interventional

A. Objectives & Hypothesis Overactive bladder (OAB) affects over 10 million adults in the United States and each year substantial costs are incurred from private and public funds to test the efficacy of new and existing drugs for OAB.14 However, effectiveness and adherence data from traditional clinical trials are not generalizable to clinical practice.3, 4 In an era of limited resources and competing demands, it is essential that cost-effectiveness data from clinical trials be generalizable to the clinical world. Pragmatic clinical trials measure the effectiveness of treatments in real clinical practice, and in the full spectrum of patients that require treatment.5 Pragmatic trials require patient reported outcomes that are valid but have low patient burden.5 The conduct of pragmatic clinical trials for OAB has been limited by a lack of instruments that have demonstrable validity and reliability in the typical clinical setting Pill counts, used to measure primary outcomes in most traditional trials, are burdensome in the clinical setting.1610 The optimal instrument for measuring utility scores, general quality of life scores for cost-effectiveness analyses for OAB, is also not known. Although poor adherence carries the potential for continued suffering for patients and wasted health care resources, there is a lack of data on the clinical and economic impact of poor adherence to treatment for OAB in real-world clinical practice. We have published preliminary data that underscores the role of adherence and utilities in the treatment of OAB. 3 Our hypothesis is that effectiveness, adherence, and utility preference scores can be measured using pragmatic patient reported instruments and that poor adherence is associated with lower effectiveness and quality of life in adults with OAB in a clinical setting. Specifically, the overriding goal of this proposal is to validate pragmatic instruments to measure effectiveness, adherence and utility preference scores and obtain preliminary data on the effect of adherence and quality of life in adults undergoing treatment for overactive bladder in a clinical setting.

NCT ID: NCT01922115 Completed - Cognitive Function Clinical Trials

The Effect of Anticholinergics on Cognitive Function in the Elderly

ACE
Start date: June 2013
Phase: Phase 4
Study type: Interventional

Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women. Subjects will be randomized to:1) trospium chloride or 2) placebo. There are three aims: 1) To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests. 2) To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management. 3) To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.

NCT ID: NCT01919047 Completed - Overactive Bladder Clinical Trials

Drug Use-Results Survey of Betanis Tablets in Japan

Start date: April 2012
Phase: N/A
Study type: Observational

This study is to determine the following information. 1. The occurrence of adverse drug reactions in clinical settings. 2. Factors potentially impacting safety, effectiveness, and other aspects.

NCT ID: NCT01912885 Completed - Clinical trials for Overactive Bladder Syndrome

Comparison of Posterior Tibial Nerve Electrical Stimulation Protocols for Overactive Bladder Syndrome

Start date: October 9, 2013
Phase: N/A
Study type: Interventional

INTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society as urgency, with or without incontinence, usually with increased urinary frequency and nocturia. It is difficult to estimate the prevalence of this syndrome because many patients do not seek medical help, despite considerable negative impact on quality of life. Lower urinary tract dysfunctions can be treated using electrical stimulation of the posterior tibial nerve. This therapy is conservative, effective, inexpensive and promotes high adhesion to treatment. It has good results, decreasing symptoms of urgency, urge-incontinence, urinary frequency and nocturia . Due to lack of consensus on the parameters of this technique, further research is necessary. OBJECTIVE: To compare the effectiveness of protocols for the electrical stimulation of the posterior tibial nerve for treatment of non-neurogenic overactive bladder. METHODS: The study was a blind randomized clinical trial. The study will accept up to 145 women with overactive bladder diagnosis for at least six months prior to the beginning of the study. The subjects will be divided into five groups: group TENS 0-1 (placebo group), group TENS 1-1 (electrical stimulation of one leg once a week), group TENS 1-2 (electrical stimulation of one leg twice a week), group TENS 2-1 (electrical stimulation of two legs one a week) and group TENS 2-2 (electrical stimulation of two legs twice a week). Physical evaluation will be done at the beginning and at the end of the treatment. Evaluation will be done using the King "s Health Questionnaire, the International Consultation Incontinence Questionnaire - Short Form, the Overactive Bladder Questionnaire, a three day urinary diary and a table for follow-up treatment.

NCT ID: NCT01908829 Completed - Urologic Diseases Clinical Trials

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

BESIDE
Start date: July 10, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

NCT ID: NCT01901120 Completed - Overactive Bladder Clinical Trials

Long-Term Specified Drug Use-results Survey of Betanis Tablets

Start date: October 2012
Phase: N/A
Study type: Observational

This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.

NCT ID: NCT01898624 Completed - Overactive Bladder Clinical Trials

Specified Drug Use-results Survey of Betanis Tablets

Start date: December 4, 2012
Phase: N/A
Study type: Observational

To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder (OAB) patients with coexisting glaucoma.

NCT ID: NCT01884753 Completed - Clinical trials for Overactive Bladder Syndrome

Correlations of 3D Urethral and Paraurethral Sonographic Findings With Urodynamic Studies, Lower Urinary Tract Symptoms & Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms.

Start date: February 2, 2014
Phase:
Study type: Observational [Patient Registry]

The main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and LUTS. Besides, the associations of the blood flow of vagina/urethra and sexual dysfunction can be explored.