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Overactive Bladder clinical trials

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NCT ID: NCT01945489 Completed - Overactive Bladder Clinical Trials

OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

COMFORT
Start date: October 28, 2013
Phase: Phase 4
Study type: Interventional

This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

NCT ID: NCT01940367 Enrolling by invitation - Overactive Bladder Clinical Trials

Electrical Nerve Stimulation for Overactive Bladder a Comparison of Treatments

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

The purpose of this study is to determine whether transcutaneous sacral nerve stimulation (TENS SNS) versus percutaneous tibial nerve stimulation (PTNS) is a more effective therapeutic option for subjects with idiopathic overactive bladder (OAB) who have failed conventional therapy. Our primary hypothesis is that TENS therapy is a more effective treatment option due to ease of use and improved subject compliance with this form of therapy.

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: 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: 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: NCT01870037 Completed - Overactive Bladder Clinical Trials

Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer

OAB
Start date: January 2013
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety of a single treatment of hMaxi-K compared to placebo (PBS-20% sucrose) administered by direct bladder wall injections. Two dose levels (16000 µg and 24000 µg; 20 or 30 bladder wall injections, respectively) in females with moderate Overactive Bladder/Detrusor overactivity (OAB/DO) of ≥6 months duration will be evaluated. In each dose level, 6 participants will receive hMaxi-K and 3 will receive placebo.

NCT ID: NCT01868516 Completed - Overactive Bladder Clinical Trials

Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder

Start date: May 2013
Phase: Phase 2
Study type: Interventional

Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate with or without incontinence (leaking). The purpose of this study is to test whether dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of OAB.

NCT ID: NCT01848366 Active, not recruiting - Overactive Bladder Clinical Trials

Biowave Overactive Bladder Trial

OAB
Start date: May 2013
Phase: N/A
Study type: Interventional

Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device and a microneedle patch electrode in patients with overactive bladder symptoms. The investigators hypothesize that after at least 6 weekly treatments there will be modest improvements in overactive bladder symptoms trending toward more improvement.