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

NCT01099345 | Terminated

• 1 other identifier: 905-UC-040
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Bladder Function

Keywords

OAB; Nocturia; Bladder function; cystometry; polysomnography

Outcome Measures

Primary Outcomes (3)

• Average nocturia individual volume void

  During night in sleep lab

• Nocturnal functional bladder capacity

  During night in sleep lab

• Total urine production

  During night in sleep lab

Secondary Outcomes (9)

• Total wake time from lights out until getting out of bed in the morning

  During night in sleep lab

• Average urgency rating

  During night in sleep lab

• Number of nocturias with urgency ≥3

  During night in sleep lab

• Percentage of subjects with ≥ 2 nocturias

  During night in sleep lab

• Time from awakening to void on CMG/PSG

  During night in sleep lab

Study Arms (2)

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

cystometry (CMG) PROCEDURE

recording device measuring pressures though catheters placed in bladder and rectum

Group 1 - OAB with DO+; Group 2- OAB with DO-

polysomnography (PSG) PROCEDURE

Recording device measuring sleep activity through electrodes attached to the subject

Group 1 - OAB with DO+; Group 2- OAB with DO-

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects identified through urology physicians, family practice physicians and advertising

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 7, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (1)