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

Completed

• Conditions: Bladder Function
• Interventions: Procedure: cystometry; Procedure: polysomnography

• Registration Number: NCT01029015
• Lead Sponsor: Astellas Pharma Inc

Brief 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. 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2009-11
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Last Update Submitted: 2011-03-03
• Last Update Posted: 2011-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Read More

Exclusion Criteria

• Diagnosis of both OAB and primary insomnia
• Diagnosis of nocturnal polyuria
• Diagnosis of BPH
• BMI >= 34

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 -OAB	cystometry	Subjects with overactive bladder (OAB)
Group 1 -OAB	polysomnography	Subjects with overactive bladder (OAB)
Group 2 - Insomnia	cystometry	Subjects with insomnia
Group 2 - Insomnia	polysomnography	Subjects with insomnia
Group 3 - Normal	cystometry	Normal Subjects
Group 3 - Normal	polysomnography	Normal Subjects

Primary Outcome Measures

Name	Time	Method
Number and proportion of voids associated with urgency	During night in sleep lab
Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings	During night in sleep lab
Time from PSG awakening to each void in minutes	During night in sleep lab