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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01029015

Acronym

Nocturia Plt 1

Enrollment

Registered

2009-12-09

Start date

2006-11-30

Completion date

2007-07-31

Last updated

2011-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Function

Keywords

OAB, Insomnia, Bladder function, cystometry, polysomnography

Brief summary

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.

Interventions

PROCEDUREcystometry

recording device measuring pressures though catheters placed in bladder and rectum

PROCEDUREpolysomnography

recording device measuring sleep activity through electrodes attached to the subject

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026