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:
Collaborator:
GlaxoSmithKline
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01029015
First received: November 30, 2009
Last updated: March 3, 2011
Last verified: November 2009

November 30, 2009
March 3, 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time from PSG awakening to each void in minutes [ Time Frame: During night in sleep lab ] [ Designated as safety issue: No ]
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.

Not Provided
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
Not Provided

*   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
Both
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01029015
905-UC-009
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP