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 (Nocturia Plt 1)

March 3, 2011 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects identified through urology physicians, sleep laboratory physicians and advertising

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and proportion of voids associated with urgency
Time Frame: During night in sleep lab
During night in sleep lab
Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings
Time Frame: During night in sleep lab
During night in sleep lab
Time from PSG awakening to each void in minutes
Time Frame: During night in sleep lab
During night in sleep lab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Use Central Contact, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

March 7, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 905-UC-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bladder Function

Clinical Trials on cystometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe