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Trials / Terminated

TerminatedNCT01099345

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

Status
Terminated
Phase
Study type
Observational
Enrollment
15 (actual)
Sponsor
Astellas Pharma Inc · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
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

Timeline

Start date
2010-07-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2010-04-07
Last updated
2014-06-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01099345. Inclusion in this directory is not an endorsement.

A Pilot Trial in a Sleep Laboratory Setting to Observe Night Time Bladder Function of Subjects With Overactive Bladder ( (NCT01099345) · Clinical Trials Directory