Nocturia Plt 1: 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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01029015

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Function	Procedure: cystometry Procedure: polysomnography

Study Design

Study Type:

Observational

Actual Enrollment :

26 participants

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

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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