The Study To Test The Effect of Standardization Of Fluid Intake In Female Patients With Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00553657
Recruitment Status : Completed
First Posted : November 5, 2007
Last Update Posted : October 26, 2010
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Brief Summary:
The purpose of this study is to determine if standardizing fluid intake in a clinic setting will reduce variability of individual voiding parameters and potentially serve as a way to limit patient exposure in the initial assessment of efficacy of compounds being developed for Overactive Bladder.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: DETROL LA (drug) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Standardization of Fluid Intake on the Variability of Measured Voiding Parameters in Female Patients With Idiopathic Overactive Bladder
Study Start Date : August 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Variability of change from baseline in mean volume per void measured on 3 consecutive days. [ Time Frame: 3 consecutive days ]

Secondary Outcome Measures :
  1. Mean change from baseline in volume voided per void. Percent and actual change from baseline in maximum volume voided, number of micturitions, number of incontinence episodes, number of urgency episodes, and time to first void on 3 consecutive days. [ Time Frame: 3 consecutive days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eligible participants will be females who are 18 years of age or older, with Overactive Bladder as evidenced by daily episodes of urgency without incontinence, which may be associated with frequency or nocturia but without bladder pain. At screening, eligible patients must report frequency, defined as at least 8 micturitions per 24 hour period.
  • Eligible patients must have signed the informed consent and must meet all inclusion and exclusion criteria as determined during the screening visit.

Exclusion Criteria:

  • Any abnormality identified on the screening examination or any other medical condition or circumstance making the patient unsuitable for participation in the study based on the Investigator's and Medical Monitor's assessment
  • Any contraindication to Detrol LA or other anti-muscarinic medications
  • Inability to consume 10 cc/kg of fluid within 30 minutes
  • Regular alcohol consumption averaging ³7 drinks/week for women (1 drink = 100mL of wine or 285mL of beer or 30mL of hard liquor)
  • Positive urine drug or alcohol at screening at screening
  • Average blood pressure measurements systolic ≥140 or diastolic ≥90 at screening at screening
  • QTcB value ≥ 450 msec at screening
  • Poorly-controlled diabetes mellitus or hypertension, as evidenced by a change in medication within the 2 months prior to initiation of the study
  • History of urinary retention or gastric retention
  • Known history of narrow-angle glaucoma
  • History of QT prolongation
  • Known reduction in hepatic or renal function
  • Concomitant Use of loop diuretics (eg. Furosemide)
  • Concomitant use of a medication that is a potent inhibitor of CYP3A4
  • Class IA or Class III antiarrhythmic medications
  • Patient is unable and/or unwilling to adhere to Lifestyle Guidelines
  • For women of child bearing potential, a positive serum β-hCG at screening or pre-dose, or an unwillingness to agree to adequate contraception from the time of screening until the completion of the study:
  • Positive for hepatitis C antibody, hepatitis B surface antigen or HIV at screening.
  • Presence of urinary tract infection within 4 weeks of screening.
  • Post-void residual of >150 mL (bladder ultrasound).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553657

Australia, New South Wales
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00553657     History of Changes
Other Study ID Numbers: BKB105190
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: October 2010

Keywords provided by GlaxoSmithKline:
Experimental Medicine

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents