Bladder FunctionNocturia Plt 1NCT01029015
Pilot Trial in Sleep Laboratory Setting to Compare the Physiology of Night Time Bladder Function in Subjects With Overactive Bladder (OAB) Versus Subjects That Have Insomnia and Healthy Normal Subjects
An observational study of Bladder Function, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Function
- What is being tested?
- cystometry and polysomnography
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jul 2007
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects identified through urology physicians, sleep laboratory physicians and advertising
Who may be able to join
- Must not have a urinary tract infection
- Time in bed between 6.5 and 9 hours for at least 5 nights per week for preceding month
- Usual bed time is before midnight (24:00 hours) and typically does not vary by ± 1 hour for preceding month
- OAB subjects
- OAB symptoms for >= 3 months
- Documented detrusor overactivity episodes within 6 months
Show all 9Show fewer
- Insomnia subjects
- Diagnosis of chronic primary insomnia
- History of > 1 month of waking up more than 2 times per night and being awake for more than 60 minutes per night for at least 3 months
Who cannot join
- Diagnosis of both OAB and primary insomnia
- Diagnosis of nocturnal polyuria
- Diagnosis of BPH
- BMI >= 34
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Phase 4, Sleep Laboratory Study Comparing the Physiology of Nocturnal Bladder Function in Subjects With Overactive Bladder - Associated Nocturia to Subjects With Primary Insomnia and Healthy Normal Subjects
This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility requirements will complete a single sleep night stay in a sleep laboratory setting. During the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the morning following the sleep night stay, subjects will complete a sleep questionnaire and this will complete their participation in the study.
- Conditions
- Bladder Function
- Being tested
- cystometry, polysomnography
- Keywords
- OAB, Insomnia, Bladder function, cystometry, polysomnography
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cystometryProcedure or surgery
recording device measuring pressures though catheters placed in bladder and rectum
polysomnographyProcedure or surgery
recording device measuring sleep activity through electrodes attached to the subject
| Study group | Role | What they receive |
|---|---|---|
| Group 1 -OAB | Subjects with overactive bladder (OAB) Receives: Procedure: cystometry; Procedure: polysomnography | |
| Group 2 - Insomnia | Subjects with insomnia Receives: Procedure: cystometry; Procedure: polysomnography | |
| Group 3 - Normal | Normal Subjects Receives: Procedure: cystometry; Procedure: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of voids associated with urgency
Measured: During night in sleep lab
Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings
Measured: During night in sleep lab
Time from PSG awakening to each void in minutes
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 posted9 Dec 2009 (estimated)
- Study startNov 2006
- Primary completionJul 2007
- Study completionJul 2007
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Investigators
- Use Central Contact, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029015
- Sponsor's protocol ID
- 905-UC-009
- Acronym
- Nocturia Plt 1
- Status last verified
- Nov 2009
- First submitted
- 30 Nov 2009
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Phase 4, Sleep Laboratory Study Comparing the Physiology of Nocturnal Bladder Function in Subjects With Overactive Bladder - Associated Nocturia to Subjects With Primary Insomnia and Healthy Normal Subjects
- ClinicalTrials.gov ID
- NCT01029015
- Acronym / sponsor ID
- Nocturia Plt 1 / 905-UC-009
- Conditions
- Bladder Function
- Keywords
- OAB, Insomnia, Bladder function, cystometry, polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 9 Dec 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.
This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility requirements will complete a single sleep night stay in a sleep laboratory setting. During the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the morning following the sleep night stay, subjects will complete a sleep questionnaire and this will complete their participation in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 -OAB | – | Procedure: cystometry, Procedure: polysomnographySubjects with overactive bladder (OAB) |
| Group 2 - Insomnia | – | Procedure: cystometry, Procedure: polysomnographySubjects with insomnia |
| Group 3 - Normal | – | Procedure: cystometry, Procedure: polysomnographyNormal Subjects |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects identified through urology physicians, sleep laboratory physicians and advertising
Key inclusion criteria (9 listed)
- Must not have a urinary tract infection
- Time in bed between 6.5 and 9 hours for at least 5 nights per week for preceding month
- Usual bed time is before midnight (24:00 hours) and typically does not vary by ± 1 hour for preceding month
- OAB subjects
- Insomnia subjects
Key exclusion criteria (4 listed)
- Diagnosis of both OAB and primary insomnia
- Diagnosis of nocturnal polyuria
- Diagnosis of BPH
- BMI >= 34
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 |
|---|---|---|
| cystometryrecording device measuring pressures though catheters placed in bladder and rectum | Procedure or surgery | Group 1 -OAB, Group 2 - Insomnia, Group 3 - Normal |
| polysomnographyrecording device measuring sleep activity through electrodes attached to the subject | Procedure or surgery | Group 1 -OAB, Group 2 - Insomnia, Group 3 - Normal |
Primary outcome
Number and proportion of voids associated with urgency
Time frame: During night in sleep lab
Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings
Time frame: During night in sleep lab
Time from PSG awakening to each void in minutes
Time frame: During night in sleep lab
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 7 Mar 2011.
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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.
Use Central Contact principal investigator
Duke University
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 9 inclusion and 4 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 7 Mar 2011. 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 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?
Number and proportion of voids associated with urgency (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 7 Mar 2011.