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

• 1 other identifier: 905-UC-009
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Function

Keywords

OAB; Insomnia; Bladder function; cystometry; polysomnography

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Group 1 -OAB

Subjects with overactive bladder (OAB)

Procedure: cystometry; Procedure: polysomnography

Group 2 - Insomnia

Subjects with insomnia

Procedure: cystometry; Procedure: polysomnography

Group 3 - Normal

Normal Subjects

Procedure: cystometry; Procedure: polysomnography

Interventions

cystometry PROCEDURE

recording device measuring pressures though catheters placed in bladder and rectum

Group 1 -OAB; Group 2 - Insomnia; Group 3 - Normal

polysomnography PROCEDURE

recording device measuring sleep activity through electrodes attached to the subject

Group 1 -OAB; Group 2 - Insomnia; Group 3 - Normal

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects identified through urology physicians, sleep laboratory physicians and advertising

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Unknown Facility

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Use Central Contact

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 9, 2009
• Study Start: November 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: March 7, 2011

Record last verified: 2009-11

Locations

US (1)