TerminatedNCT01099345Updated Jun 4, 2014

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

An observational study in Bladder Function, sponsored by Astellas Pharma Inc. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-04.

Sponsored by Astellas Pharma Inc · Observational

Why this study was terminated

Slow Enrollment

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 15
Ages: 18 Years and older
Sex: Female

Study summary

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.

Conditions studied

Bladder Function

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Keywords

OAB
Nocturia
Bladder function
cystometry
polysomnography

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 15 is below the median of 109 across 166 observational studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Subjects identified through urology physicians, family practice physicians and advertising

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

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 design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 15 participants (actual)

Groups and cohorts

Group 1 - OAB with DO+
Subjects that DO+ nocturia
Procedure: cystometry (CMG) · Procedure: polysomnography (PSG)
Group 2- OAB with DO-
Subjects that DO- nocturia
Procedure: cystometry (CMG) · Procedure: polysomnography (PSG)

Interventions

Procedurecystometry (CMG)
recording device measuring pressures though catheters placed in bladder and rectum
Procedurepolysomnography (PSG)
Recording device measuring sleep activity through electrodes attached to the subject

What researchers measure

Primary outcomes

Average nocturia individual volume void
Time frame: During night in sleep lab
Nocturnal functional bladder capacity
Time frame: During night in sleep lab
Total urine production
Time frame: During night in sleep lab

Secondary outcomes

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

Study locations

1 site

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

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01099345
Lead sponsor: Astellas Pharma Inc
Responsible party: Sponsor
First posted: Apr 7, 2010
Start date: Jul 2010
Primary completion: May 2012
Completion: May 2012
Last update: Jun 4, 2014

Study contacts

Medical Director

study director · Astellas Pharma Global Development

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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