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 (Nocturia Plt 1)

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Astellas

Status

Completed

Conditions

Bladder Function

Treatments

Procedure: cystometry
Procedure: polysomnography

Study type

Observational

Funder types

Industry

Identifiers

NCT01029015
905-UC-009

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

26 participants in 3 patient groups

Group 1 -OAB
Description:
Subjects with overactive bladder (OAB)
Treatment:
Procedure: polysomnography
Procedure: cystometry
Group 2 - Insomnia
Description:
Subjects with insomnia
Treatment:
Procedure: polysomnography
Procedure: cystometry
Group 3 - Normal
Description:
Normal Subjects
Treatment:
Procedure: polysomnography
Procedure: cystometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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