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
  Purpose

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.


Condition Intervention Phase
Bladder Function
Procedure: cystometry
Procedure: polysomnography
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: November 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 -OAB
Subjects with overactive bladder (OAB)
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 2 - Insomnia
Subjects with insomnia
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 3 - Normal
Normal Subjects
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects identified through urology physicians, sleep laboratory physicians and advertising

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029015

Locations
United States, North Carolina
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Astellas Pharma Inc
GlaxoSmithKline
Investigators
Principal Investigator: Use Central Contact Duke University
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01029015     History of Changes
Other Study ID Numbers: 905-UC-009
Study First Received: November 30, 2009
Last Updated: March 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
OAB
Insomnia
Bladder function
cystometry
polysomnography

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014