The Effect of Position on Urge Sensation in Volunteers and in Patients With Overactive Bladder Syndrome
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|ClinicalTrials.gov Identifier: NCT00821314|
Recruitment Status : Unknown
Verified June 2010 by Maastricht University Medical Center.
Recruitment status was: Recruiting
First Posted : January 13, 2009
Last Update Posted : June 16, 2010
Importance of the problem OAB is a common health problem. Milsom et al.  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.  showed that OAB adversely affected the lives of the majority (65%) of the respondents who reported OAB symptoms. Chen et al.  also reported that the prevalence of OAB in Taiwanese women was similar to that of Western women. In the study of Chen et al., 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 (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.
|Condition or disease|
|Overactive Bladder Syndrome|
It is necessary to state whether correlations between objective findings and subjective perception of symptoms exist, and whether the patient's 'everyday' symptoms are reproduced during objective studies, when the results are reported. The principle aim of urodynamics is to reproduce a patient's symptoms and to provide a patho physiological explanation for them. The purposes of this study is to evaluate whether there is a relation between the position (sitting/standing up vs supine position) and the bladder sensations in both healthy volunteers and patients with OAB. Furthermore we would like to study patient perception of bladder condition and bladder filling and volumes voided as well as the functional and maximal bladder capacity in patients with OAB.
Because patients with pelvic floor dysfunction have widely varying expectations from treatment, the patient's goal for treatment is highly subjective. Therefore, strategies for assessing OAB should incorporate self-perceived disease condition.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||The Effect of Position (Sit/Stand up vs Supine Position) on Urge Sensation in Volunteers and in Patients With Overactive Bladder Syndrome|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||December 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821314
|Contact: Mohammad S Rahnama'i, M.D.||0031 43 firstname.lastname@example.org|
|Maastricht University Hospital||Recruiting|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Principal Investigator:||Mohammad S Rahnama'i`, MD||University hospital Maasticht|