Overactive Bladder SyndromeNCT00821314
The Effect of Position on Urge Sensation in Volunteers and in Patients With Overactive Bladder Syndrome
An observational study of Overactive Bladder Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder Syndrome
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Hospital
Maastricht, Limburg, 6202 AZ
About this study
Official title: 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.
Read more
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
Read the detailed description
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.
- Conditions
- Overactive Bladder Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Mohammad S Rahnama'i', MD, Principal investigator, University hospital Maasticht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821314
- Sponsor's protocol ID
- MEC 08-2-128.3
- Status last verified
- Jun 2010
- First submitted
- 12 Jan 2009
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Position (Sit/Stand up vs Supine Position) on Urge Sensation in Volunteers and in Patients With Overactive Bladder Syndrome
- ClinicalTrials.gov ID
- NCT00821314
- Acronym / sponsor ID
- MEC 08-2-128.3
- Conditions
- Overactive Bladder Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad S Rahnama'i', MD principal investigator
University hospital Maasticht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad S Rahnama'i, M.D. (0031 43 38877256, s.rahnamai@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2010.