A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder (OAB)

A Pilot, Overactive Bladder Syndrome Study Utilizing a Sleep Laboratory Setting to Compare Detrusor Positive Nocturia Female Subjects to Detrusor Negative Nocturia Female Subjects

This is an observational, pilot, non-treatment study to evaluate and develop clinical variables for distinguishing female OAB subjects that have detrusor overactivity positive (DO+) nocturia from female OAB subjects that have detrusor overactivity negative (DO-) nocturia utilizing a sleep laboratory setting.

Study Overview

• Status: Terminated
• Conditions: Bladder Function
• Intervention / Treatment: Procedure: cystometry (CMG); Procedure: polysomnography (PSG)

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Subjects identified through urology physicians, family practice physicians and advertising

Description

Inclusion Criteria:

• Subject must have confirmed diagnosis of OAB and OAB symptoms for ≥ 3 months
• Subject must have documented detrusor overactivity
• Subject must not be taking any OAB medication for at least 14 days
• Subject has no sleep related conditions (other than nocturia)

Exclusion Criteria:

• Subject has active urinary tract infection (UTI)
• Subject has significant stress incontinence or mixed stress/urge incontinence
• Subject has nocturnal polyuria
• Subject has history of sleep apnea
• Subject has indwelling urinary catheterization within 4 weeks
• Subject using medication that effects urinary and sleep function
• Subject is unable to refrain from alcohol or smoking during the sleep night stay
• Subject has an unstable medical or psychiatric disorder
• Subject has a history of cardiovascular concerns
• Subject is pregnant, breastfeeding or plans to become pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 - OAB with DO+; Subjects that DO+ nocturia	Procedure: cystometry (CMG); recording device measuring pressures though catheters placed in bladder and rectum; Procedure: polysomnography (PSG); Recording device measuring sleep activity through electrodes attached to the subject
Group 2- OAB with DO-; Subjects that DO- nocturia	Procedure: cystometry (CMG); recording device measuring pressures though catheters placed in bladder and rectum; Procedure: polysomnography (PSG); Recording device measuring sleep activity through electrodes attached to the subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average nocturia individual volume void	During night in sleep lab
Nocturnal functional bladder capacity	During night in sleep lab
Total urine production	During night in sleep lab

Secondary Outcome Measures

Outcome Measure	Time Frame
Total wake time from lights out until getting out of bed in the morning	During night in sleep lab
Average urgency rating	During night in sleep lab
Number of nocturias with urgency ≥3	During night in sleep lab
Percentage of subjects with ≥ 2 nocturias	During night in sleep lab
Time from awakening to void on CMG/PSG	During night in sleep lab
Number of awakenings	During night in sleep lab
Wake time after sleep onset	During night in sleep lab
Sleep onset latency	During night in sleep lab
For DO+ subjects, number of nocturias associated with DO+	During night in sleep lab

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to Results on JAPIC

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: April 6, 2010
• First Posted (Estimate): April 7, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 2, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: polysomnography; OAB; Bladder function; Nocturia; cystometry
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Nocturia
• Other Study ID Numbers: 905-UC-040