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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00821314
First received: January 12, 2009
Last updated: June 15, 2010
Last verified: June 2010

January 12, 2009
June 15, 2010
April 2009
December 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00821314 on ClinicalTrials.gov Archive Site
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The Effect of Position on Urge Sensation in Volunteers and in Patients With Overactive Bladder Syndrome
The Effect of Position (Sit/Stand up vs Supine Position) on Urge Sensation in Volunteers and in Patients With Overactive Bladder Syndrome

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

The study population consists of two groups. One group consist of patients with OAB. The second group consist of volunteers without micturition complaints. (25 male & 25 female)

The second group of patients with OAB. (25 male& 25 female) Both groups will be subjected to the exact same protocol.

Overactive Bladder Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • OAB must be diagnosed by their urologist using the criteria of more than 8 micturitions on three consecutive days of these three days they keep a micturation diary with a VAS score for urge sensation.
  • Patients should have at least one episode of urge.

Exclusion Criteria:

  • Patients with congestive heart disease and patients with a history of heart failure.
  • Patients with a post voiding residual volume of more than 100 cc.
Both
18 Years and older
Yes
Contact: Mohammad S Rahnama'i, M.D. 0031 43 38877256 s.rahnamai@yahoo.com
Netherlands
 
NCT00821314
MEC 08-2-128.3
Yes
Prof Dr P. E. V. van Kerrebroeck, Head of the Urology department University Hospital Maastricht, The Netherlands
Maastricht University Medical Center
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Principal Investigator: Mohammad S Rahnama'i`, MD University hospital Maasticht
Maastricht University Medical Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP