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

Bladder Function Clinical Trial

— Nocturia Plt 1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029015
• Other study ID #: 905-UC-009
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2009
• Last updated: March 3, 2011
• Start date: November 2006
• Est. completion date: July 2007

Study information

• Verified date: November 2009
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Function
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and proportion of voids associated with urgency		During night in sleep lab	No
Primary	Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings		During night in sleep lab	No
Primary	Time from PSG awakening to each void in minutes		During night in sleep lab	No