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

Bladder Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01099345
• Other study ID #: 905-UC-040
• Status: Terminated
• Phase: N/A
• First received: March 30, 2010
• Last updated: June 2, 2014
• Start date: July 2010
• Est. completion date: May 2012

Study information

• Verified date: June 2014
• 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, 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Function
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average nocturia individual volume void		During night in sleep lab	No
Primary	Nocturnal functional bladder capacity		During night in sleep lab	No
Primary	Total urine production		During night in sleep lab	No
Secondary	Total wake time from lights out until getting out of bed in the morning		During night in sleep lab	No
Secondary	Average urgency rating		During night in sleep lab	No
Secondary	Number of nocturias with urgency =3		During night in sleep lab	No
Secondary	Percentage of subjects with = 2 nocturias		During night in sleep lab	No
Secondary	Time from awakening to void on CMG/PSG		During night in sleep lab	No
Secondary	Number of awakenings		During night in sleep lab	No
Secondary	Wake time after sleep onset		During night in sleep lab	No
Secondary	Sleep onset latency		During night in sleep lab	No
Secondary	For DO+ subjects, number of nocturias associated with DO+		During night in sleep lab	No

External Links

•   Link to Results on JAPIC