Overactive Bladder SyndromeNCT00982241
Overactive Bladder (OAB) Drink Advice Study
A study testing water in people with Overactive Bladder Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The researchers want to investigate how fluid intake influences the symptoms of OAB. The researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while filling in an standard micturation diary for 2 days. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2009to Dec 2010
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OAB patients
Who cannot join
- benign prostatic hyperplasia
- neurogenic detrusor overactivity
- urine tract infection
- anticholinergics
- intravesical botulin toxin
- cardiac failure
Show all 9Show fewer
- renal insufficiency
- sacral neurostimulation
- percutaneous neurostimulation
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dept. of Urology, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)
The researchers want to investigate how fluid intake influences the symptoms of OAB. The researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while filling in an standard micturation diary for 2 days. This micturation diary is coupled to: collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine samples will be analysed for osmolality by the clinical chemistry department.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- water
- Keywords
- OAB, urine, osmolality, urge, fluid intake, PPIUS, urge score, bladder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterDietary supplement
drinking water / normal dietary fluids for oral intake
| Study group | Role | What they receive |
|---|---|---|
| normal fluid intake | Active comparator | 1500 ml /day (+/- 300 ml) for 2,5 days Receives: Dietary Supplement: water |
| high fluid intake | Active comparator | 2400 ml/day (+/- 300 ml )for 2,5 days Receives: Dietary Supplement: water |
| low fluid intake | Active comparator | fluid intake 900 ml/day (+/- 300ml) for 2,5 days Receives: Dietary Supplement: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine osmolality
Measured: 2 days
PPIUS urge-score
Measured: 2 days
Secondary outcomes (2)
urine pH
Measured: 2 days
PPIUS urge score
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2010
Why it stopped: Difficulty in enrolling participants
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Heesakkers, dr. MD, Study chair, dept of Urology, Radboud University Nijmegen Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982241
- Sponsor's protocol ID
- OABdrinkstudy
- Status last verified
- Sep 2009
- First submitted
- 22 Sep 2009
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)
- ClinicalTrials.gov ID
- NCT00982241
- Acronym / sponsor ID
- OABdrinkstudy
- Conditions
- Overactive Bladder Syndrome
- Keywords
- OAB, urine, osmolality, urge, fluid intake, PPIUS, urge score, bladder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in enrolling participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- First posted
- 23 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.
The researchers want to investigate how fluid intake influences the symptoms of OAB. The researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while filling in an standard micturation diary for 2 days. This micturation diary is coupled to: collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine samples will be analysed for osmolality by the clinical chemistry department.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal fluid intake | Active comparator | Dietary Supplement: water1500 ml /day (+/- 300 ml) for 2,5 days |
| high fluid intake | Active comparator | Dietary Supplement: water2400 ml/day (+/- 300 ml )for 2,5 days |
| low fluid intake | Active comparator | Dietary Supplement: waterfluid intake 900 ml/day (+/- 300ml) for 2,5 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- OAB patients
Key exclusion criteria (9 listed)
- benign prostatic hyperplasia
- neurogenic detrusor overactivity
- urine tract infection
- anticholinergics
- intravesical botulin toxin
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 |
|---|---|---|
| waterdrinking water / normal dietary fluids for oral intake | Dietary supplement | high fluid intake, low fluid intake, normal fluid intake |
Primary outcome
urine osmolality
Time frame: 2 days
PPIUS urge-score
Time frame: 2 days
2 secondary outcomes
urine pH
Time frame: 2 days
PPIUS urge score
Time frame: 2 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
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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.
John Heesakkers, dr. MD study chair
dept of Urology, Radboud University Nijmegen Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water in people with Overactive Bladder Syndrome, run by Radboud 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 1 inclusion and 9 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: withdrawn, as of the sponsor's last update on 24 Jul 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
urine osmolality (time frame: 2 days). The study lists 2 primary outcomes in all. 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 24 Jul 2012.