Bladder FunctionNCT01099345
A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB)
An observational study of Bladder Function, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
This is an observational, pilot, non-treatment study to evaluate and develop clinical variables for distinguishing female OAB subjects that have detrusor overactivity positive (DO+) nocturia from female OAB subjects that have detrusor overactivity negative (DO-) nocturia utilizing a sleep laboratory setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bladder Function
- What is being tested?
- cystometry (CMG) and polysomnography (PSG)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2012
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects identified through urology physicians, family practice physicians and advertising
Who may be able to join
- Subject must have confirmed diagnosis of OAB and OAB symptoms for ≥ 3 months
- Subject must have documented detrusor overactivity
- Subject must not be taking any OAB medication for at least 14 days
- Subject has no sleep related conditions (other than nocturia)
Who cannot join
- Subject has active urinary tract infection (UTI)
- Subject has significant stress incontinence or mixed stress/urge incontinence
- Subject has nocturnal polyuria
- Subject has history of sleep apnea
- Subject has indwelling urinary catheterization within 4 weeks
- Subject using medication that effects urinary and sleep function
Show all 10Show fewer
- Subject is unable to refrain from alcohol or smoking during the sleep night stay
- Subject has an unstable medical or psychiatric disorder
- Subject has a history of cardiovascular concerns
- Subject is pregnant, breastfeeding or plans to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: A Pilot, Overactive Bladder Syndrome Study Utilizing a Sleep Laboratory Setting to Compare Detrusor Positive Nocturia Female Subjects to Detrusor Negative Nocturia Female Subjects
This is an observational, pilot, non-treatment study to evaluate and develop clinical variables for distinguishing female OAB subjects that have detrusor overactivity positive (DO+) nocturia from female OAB subjects that have detrusor overactivity negative (DO-) nocturia utilizing a sleep laboratory setting.
- Conditions
- Bladder Function
- Being tested
- cystometry (CMG), polysomnography (PSG)
- Keywords
- OAB, Nocturia, Bladder function, cystometry, polysomnography
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cystometry (CMG)Procedure or surgery
recording device measuring pressures though catheters placed in bladder and rectum
polysomnography (PSG)Procedure or surgery
Recording device measuring sleep activity through electrodes attached to the subject
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - OAB with DO+ | Subjects that DO+ nocturia Receives: Procedure: cystometry (CMG); Procedure: polysomnography (PSG) | |
| Group 2- OAB with DO- | Subjects that DO- nocturia Receives: Procedure: cystometry (CMG); Procedure: polysomnography (PSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average nocturia individual volume void
Measured: During night in sleep lab
Nocturnal functional bladder capacity
Measured: During night in sleep lab
Total urine production
Measured: During night in sleep lab
Secondary outcomes (9)
Total wake time from lights out until getting out of bed in the morning
Measured: During night in sleep lab
Average urgency rating
Measured: During night in sleep lab
Number of nocturias with urgency ≥3
Measured: During night in sleep lab
Percentage of subjects with ≥ 2 nocturias
Measured: During night in sleep lab
Time from awakening to void on CMG/PSG
Measured: During night in sleep lab
Number of awakenings
Measured: During night in sleep lab
Wake time after sleep onset
Measured: During night in sleep lab
Sleep onset latency
Measured: During night in sleep lab
For DO+ subjects, number of nocturias associated with DO+
Measured: During night in sleep lab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Slow Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder FunctionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099345
- Sponsor's protocol ID
- 905-UC-040
- Status last verified
- Jun 2014
- First submitted
- 30 Mar 2010
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Overactive Bladder Syndrome Study Utilizing a Sleep Laboratory Setting to Compare Detrusor Positive Nocturia Female Subjects to Detrusor Negative Nocturia Female Subjects
- ClinicalTrials.gov ID
- NCT01099345
- Acronym / sponsor ID
- 905-UC-040
- Conditions
- Bladder Function
- Keywords
- OAB, Nocturia, Bladder function, cystometry, polysomnography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Apr 2010 (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.
This is an observational, pilot, non-treatment study to evaluate and develop clinical variables for distinguishing female OAB subjects that have detrusor overactivity positive (DO+) nocturia from female OAB subjects that have detrusor overactivity negative (DO-) nocturia utilizing a sleep laboratory setting.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - OAB with DO+ | – | Procedure: cystometry (CMG), Procedure: polysomnography (PSG)Subjects that DO+ nocturia |
| Group 2- OAB with DO- | – | Procedure: cystometry (CMG), Procedure: polysomnography (PSG)Subjects that DO- nocturia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects identified through urology physicians, family practice physicians and advertising
Key inclusion criteria (4 listed)
- Subject must have confirmed diagnosis of OAB and OAB symptoms for ≥ 3 months
- Subject must have documented detrusor overactivity
- Subject must not be taking any OAB medication for at least 14 days
- Subject has no sleep related conditions (other than nocturia)
Key exclusion criteria (10 listed)
- Subject has active urinary tract infection (UTI)
- Subject has significant stress incontinence or mixed stress/urge incontinence
- Subject has nocturnal polyuria
- Subject has history of sleep apnea
- Subject has indwelling urinary catheterization within 4 weeks
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 |
|---|---|---|
| cystometry (CMG)recording device measuring pressures though catheters placed in bladder and rectum | Procedure or surgery | Group 1 - OAB with DO+, Group 2- OAB with DO- |
| polysomnography (PSG)Recording device measuring sleep activity through electrodes attached to the subject | Procedure or surgery | Group 1 - OAB with DO+, Group 2- OAB with DO- |
Primary outcome
Average nocturia individual volume void
Time frame: During night in sleep lab
Nocturnal functional bladder capacity
Time frame: During night in sleep lab
Total urine production
Time frame: During night in sleep lab
9 secondary outcomes
Total wake time from lights out until getting out of bed in the morning
Time frame: During night in sleep lab
Average urgency rating
Time frame: During night in sleep lab
Number of nocturias with urgency ≥3
Time frame: During night in sleep lab
Percentage of subjects with ≥ 2 nocturias
Time frame: During night in sleep lab
Time from awakening to void on CMG/PSG
Time frame: During night in sleep lab
Number of awakenings
Time frame: During night in sleep lab
Wake time after sleep onset
Time frame: During night in sleep lab
Sleep onset latency
Time frame: During night in sleep lab
For DO+ subjects, number of nocturias associated with DO+
Time frame: During night in sleep lab
Results and safety
The study was stopped early (reason given: Slow Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
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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.
Medical Director study director
Astellas Pharma Global Development
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 Bladder Function, run by Astellas Pharma Inc at 1 site in United States.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 4 Jun 2014. 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 United States. 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 stopped early (reason given: Slow Enrollment). Results are not available in the source record.
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?
Average nocturia individual volume void (time frame: During night in sleep lab). The study lists 3 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 4 Jun 2014.