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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 (Nocturia Plt 1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01029015
First Posted: December 9, 2009
Last Update Posted: March 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
Astellas Pharma Inc
November 30, 2009
December 9, 2009
March 7, 2011
November 2006
July 2007   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01029015 on ClinicalTrials.gov Archive Site
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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
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.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample
Subjects identified through urology physicians, sleep laboratory physicians and advertising
Bladder Function
  • Procedure: cystometry
    recording device measuring pressures though catheters placed in bladder and rectum
  • Procedure: polysomnography
    recording device measuring sleep activity through electrodes attached to the subject
  • Group 1 -OAB
    Subjects with overactive bladder (OAB)
    Interventions:
    • Procedure: cystometry
    • Procedure: polysomnography
  • Group 2 - Insomnia
    Subjects with insomnia
    Interventions:
    • Procedure: cystometry
    • Procedure: polysomnography
  • Group 3 - Normal
    Normal Subjects
    Interventions:
    • Procedure: cystometry
    • Procedure: polysomnography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • Diagnosis of both OAB and primary insomnia
  • Diagnosis of nocturnal polyuria
  • Diagnosis of BPH
  • BMI >= 34
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01029015
905-UC-009
No
Not Provided
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Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
Astellas Pharma Inc
GlaxoSmithKline
Principal Investigator: Use Central Contact Duke University
Astellas Pharma Inc
November 2009