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

NCT01029015 — Completed, 26 participants, Astellas Pharma Inc

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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

Registry	NCT01029015, acronym Nocturia Plt 1
Status	Completed
Study type	Observational
Enrollment	26 (Actual)
Sponsor	Astellas Pharma Inc (Industry); collaborators: GlaxoSmithKline
Conditions	Bladder Function
Interventions	cystometry, polysomnography (Procedure)
Dates	start 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 in United States

-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.

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+Arms and interventions

Arm	Interventions	Description
Group 1 -OAB	Procedure: cystometry; Procedure: polysomnography	Subjects with overactive bladder (OAB)
Group 2 - Insomnia	Procedure: cystometry; Procedure: polysomnography	Subjects with insomnia
Group 3 - Normal	Procedure: cystometry; Procedure: polysomnography	Normal Subjects

cystometry (Procedure): recording device measuring pressures though catheters placed in bladder and rectum
polysomnography (Procedure): recording device measuring sleep activity through electrodes attached to the subject

+Outcome measures

Primary outcomes

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

Sex: All, ages: 45 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
	Durham, North Carolina	United States

+Investigators

Use Central Contact, Principal investigator, Duke University