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Urinary Bladder, Overactive clinical trials

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NCT ID: NCT01540214 Recruiting - Clinical trials for Pelvic Organ Prolapse

Study of Overactive Bladder in Women With Prolapse

SOAP
Start date: February 2012
Phase: N/A
Study type: Observational

Pelvic organ prolapse (POP) is a common problem. Symptoms of overactive bladder (OAB) are present in approximately 50% of patients with POP. For many women the accompanying symptoms of OAB are an important reason for seeking help for their POP. Surgical repair of prolapse may improve OAB complaints. Persisting or de novo OAB symptoms are strongly correlated with dissatisfaction with the final results of an operation for POP. The primary aim of this research project is to investigate the difference in prevalence (i.e. improvement) of OAB and bothersome OAB symptoms at 6 and 12 months after POP repair surgery. The secondary objectives are to determine changes in bladder function at 6 and 12 months after surgery and to identify predictive factors for persistence, disappearance or de novo symptoms of OAB after POP surgery. Women who present with POP and who will undergo surgical treatment will be evaluated at baseline before their surgery and will be followed for the duration of one year after surgery.

NCT ID: NCT01227447 Recruiting - Clinical trials for Incontinence, Overactive Bladder, Stress Urinary Incontinence

Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Human Urinary Outflow Tract

Start date: January 2010
Phase: N/A
Study type: Observational

The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further characterise morphology and function of the suburothelial myofibroblast network in the human bladder outlet.

NCT ID: NCT01050114 Recruiting - Overactive Bladder Clinical Trials

OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER

Start date: August 2013
Phase: Phase 3
Study type: Interventional

Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine). OnaBoNT-A bladder injections have been studied in clinical research trials. The results have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by increasing the amount of urine the bladder can hold. This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. A second purpose of the study is to perform research tests on the urine samples provided by the volunteers. Urine presents a rich source of information for bladder diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to learn if there are yet undiscovered reasons for urinary diseases. These tests would be very beneficial because the results would lead to better treatment of the urinary diseases. Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg capsule twice a day. The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo contains no active medicine. Participation in this study will be about 6-7 months and involve 5 visits to the clinic. The risks of bladder onaBoNT-A

NCT ID: NCT00839969 Recruiting - Clinical trials for Overactive Bladder Syndrome

Cystoscopy Plus Urethral Dilatation Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome and Impaired Voiding

Start date: January 2009
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00821314 Recruiting - Clinical trials for Overactive Bladder Syndrome

The Effect of Position on Urge Sensation in Volunteers and in Patients With Overactive Bladder Syndrome

Start date: April 2009
Phase: N/A
Study type: Observational

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

NCT ID: NCT00479596 Recruiting - Overactive Bladder Clinical Trials

This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo.

BTX0621
Start date: January 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The current study will investigate the comparative efficacy, safety and patient satisfaction of intradetrusor injections BOTOX® injections (200U) versus placebo (saline) injections in the treatment of OAB secondary to benign prostatic obstruction (BPO).

NCT ID: NCT00437528 Recruiting - Overactive Bladder Clinical Trials

Safety and Applicability Study of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Capacity

Start date: November 2006
Phase: Phase 1
Study type: Observational

A novel sensor (a device named sensurine)was developed in the aim of real- time measurement of bladder volume. The sensurine device is a wearable, fully passive, non-invasive and compact heat flow sensor (patent pending) and electronic control unit. The device will serve as a tool for managing and treating bladder dysfunction (by behavioral treatment), such as overactive bladder without incontinence, urge incontinence and voiding difficulties. In this phase I of the clinical trial the sensor unit will be tested for technological feasibility demonstration and for collecting design data.

NCT ID: NCT00313924 Recruiting - Overactive Bladder Clinical Trials

Assessing the OAB-8 Questionnaire as a Tool to Measure Treatment Outcome

Start date: February 2006
Phase: Phase 4
Study type: Interventional

OAB is a widespread medical problem affecting 6- 30% of the population (both sexes and all age groups) in Europe1 and 16%2-18%3 of the US and Canadian population. Nevertheless only a small proportion of this group turns to seek medical help. Once treated, evaluation of treatment outcome is problematic since outcome measures for success vary widely (i.e. improvement in number of incontinence episodes, number of urge episodes, change in frequency and nocturia etc) but do not include measures of patient reported outcomes. The OAB Assessment Tool is a self-administered questionnaire (8-question self–filled survey) primarily intended to identify patients with symptoms of OAB. The same comparable information could be obtained after a certain treatment period, thus providing accurate and precise measures of success. It could also offer insight to the changes of the different parameters that make up the problem. Due to its ease of administration and its high specificity in assessing OAB, the OAB Assessment Tool seems to be optimal for this objective.