NCT01029015

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bladder Function

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2009-12-09
• Last updated: 2011-03-07

Locations

1 site across 1 country: United States