Urinary Bladder, OveractiveNCT00971646
Cohort Study: Perceptual Urge Sensation
An observational study of Urinary Bladder, Overactive and Osteoporosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Over the past few years it has become clear that our understanding of bladder physiology is inadequate to explain urge incontinence. This has forced us to re-evaluate what we know and do not know about bladder function and dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive, Osteoporosis
- What is being tested?
- Micturition diary, Hospital Anxiety and Depression scale and EuroQol-5D
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2010to 1 Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of two groups: 1: patients with OAB; 2: patients with osteoporosis. The patients with OAB will be reqruited from the outpatient clinic and website designed for patients with overactive bladder symptoms. The patients with osteoporosis will be recruited from an electronic patient database.
Who may be able to join
- Patients older than 18 years with OAB 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: sudden compelling desire to void which can not be postponed.
- Well versed in Dutch.
- Patients older than 18 years with osteoporosis joined into the Fast Guide cohort program.
- Well versed in Dutch.
Who cannot join
- Patients with stress-urinary incontinence
- Presence of post void residual urine > 100cc determined by ultrasound
- Presence of urinary tract infection, determined by urine sticks. Patients with urinary tract infection will be treated by antibiotics. After resolution of the infection, the patient can re-enter the study if the urine is sterile at that moment.
- Urinary complaints or urologic history
- Presence of postvoid residual urine > 100cc determined by ultrasound
- Presence of urinary tract infection, determined by urine sticks. Patients that present with urinary tract infection will be definitively excluded from participation.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
About this study
Over the past few years it has become clear that our understanding of bladder physiology is inadequate to explain urge incontinence. This has forced us to re-evaluate what we know and do not know about bladder function and dysfunction. This has led to the identification and study of novel systems within the bladder that may contribute to abnormal sensations.
The investigators now suspect that the organic changes occurring in the bladder are not the whole story. For one group of patients with pathological urge there is growing evidence suggesting that there may be a strong psychological component. The idea now being put forward is that normal afferent peripheral information is perceived as abnormal and excessive, resulting in an increased desire to go to the bathroom: 'perceptual urge'. It is important to identify this group of patients since it will direct their treatment towards more cognitive approaches. Also, if such a psychological aetiology can be eliminated it would lead to a more focused and effective management of peripheral pathology with surgery or pharmacology.
- Conditions
- Urinary Bladder, Overactive, Osteoporosis
- Being tested
- Micturition diary, Hospital Anxiety and Depression scale, EuroQol-5D, Self-consciousness questionnaire
- Keywords
- overactive bladder, self-consciousness, perceptual urge sensation
- Medical subject headings
- Urinary Bladder, Overactive, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micturition diaryOther
On the micturition diary patients are asked to note every void and drink. With every void they are asked to estimate their bladder volume and grade their degree of desire to void.
Hospital Anxiety and Depression scaleOther
This questionnaire is designed to screen for the presence of a mood disorder.
EuroQol-5DOther
This questionnaire grades the health condition of the subject.
Self-consciousness questionnaireOther
The questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self.
| Study group | Role | What they receive |
|---|---|---|
| OAB | Patients with overactive bladder syndrome Receives: Other: Micturition diary; Other: Hospital Anxiety and Depression scale; Other: EuroQol-5D; Other: Self-consciousness questionnaire | |
| Osteoporosis | Patients with osteoporosis Receives: Other: Micturition diary; Other: Hospital Anxiety and Depression scale; Other: EuroQol-5D; Other: Self-consciousness questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defining differences in self-consciousness and HADS scores in patients with OAB
Measured: 1 year
Secondary outcomes (2)
Defining differences between self-consciousness and HADS scores between the two cohorts
Measured: 1 year
Defining differences in quality of life between the two cohorts
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJun 2010
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gommert van Koeveringe, MD, PhD, urologist, Study director, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971646
- Sponsor's protocol ID
- 09-1234567
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2009
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study: Perceptual Urge Sensation
- ClinicalTrials.gov ID
- NCT00971646
- Acronym / sponsor ID
- 09-1234567
- Conditions
- Urinary Bladder, Overactive, Osteoporosis
- Keywords
- overactive bladder, self-consciousness, perceptual urge sensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 4 Sep 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.
Over the past few years it has become clear that our understanding of bladder physiology is inadequate to explain urge incontinence. This has forced us to re-evaluate what we know and do not know about bladder function and dysfunction. This has led to the identification and study of novel systems within the bladder that may contribute to abnormal sensations.
The investigators now suspect that the organic changes occurring in the bladder are not the whole story. For one group of patients with pathological urge there is growing evidence suggesting that there may be a strong psychological component. The idea now being put forward is that normal afferent peripheral information is perceived as abnormal and excessive, resulting in an increased desire to go to the bathroom: 'perceptual urge'. It is important to identify this group of patients since it will direct their treatment towards more cognitive approaches. Also, if such a psychological aetiology can be eliminated it would lead to a more focused and effective management of peripheral pathology with surgery or pharmacology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OAB | – | Other: Micturition diary, Other: Hospital Anxiety and Depression scale, Other: EuroQol-5D, Other: Self-consciousness questionnairePatients with overactive bladder syndrome |
| Osteoporosis | – | Other: Micturition diary, Other: Hospital Anxiety and Depression scale, Other: EuroQol-5D, Other: Self-consciousness questionnairePatients with osteoporosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of two groups: 1: patients with OAB; 2: patients with osteoporosis. The patients with OAB will be reqruited from the outpatient clinic and website designed for patients with overactive bladder symptoms. The patients with osteoporosis will be recruited from an electronic patient database.
Key inclusion criteria (5 listed)
- Patients older than 18 years with OAB 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: sudden compelling desire to void which can not be postponed.
- Well versed in Dutch.
- Patients older than 18 years with osteoporosis joined into the Fast Guide cohort program.
- Well versed in Dutch.
Key exclusion criteria (6 listed)
- Patients with stress-urinary incontinence
- Presence of post void residual urine > 100cc determined by ultrasound
- Presence of urinary tract infection, determined by urine sticks. Patients with urinary tract infection will be treated by antibiotics. After resolution of the infection, the patient can re-enter the study if the urine is sterile at that moment.
- Urinary complaints or urologic history
- Presence of postvoid residual urine > 100cc determined by ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micturition diaryOn the micturition diary patients are asked to note every void and drink. With every void they are asked to estimate their bladder volume and grade their degree of desire to void. | Other | OAB, Osteoporosis |
| Hospital Anxiety and Depression scaleThis questionnaire is designed to screen for the presence of a mood disorder. | Other | OAB, Osteoporosis |
| EuroQol-5DThis questionnaire grades the health condition of the subject. | Other | OAB, Osteoporosis |
| Self-consciousness questionnaireThe questions tap cognitive, emotional, and physical appearance aspects of directing their attention to the self. | Other | OAB, Osteoporosis |
Primary outcome
Defining differences in self-consciousness and HADS scores in patients with OAB
Time frame: 1 year
2 secondary outcomes
Defining differences between self-consciousness and HADS scores between the two cohorts
Time frame: 1 year
Defining differences in quality of life between the two cohorts
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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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.
Gommert van Koeveringe, MD, PhD, urologist study director
Maastricht University Medical Centre
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 Urinary Bladder, Overactive and Osteoporosis, 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defining differences in self-consciousness and HADS scores in patients with OAB (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 6 Sep 2018.