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Urinary Cytokines in Patients With Overactive Bladder (OAB)

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: NCT00868621
Recruitment Status : Unknown
Verified March 2009 by Cleveland Clinic Florida.
Recruitment status was:  Active, not recruiting
First Posted : March 25, 2009
Last Update Posted : March 25, 2009
Astellas Pharma US, Inc.
Information provided by:
Cleveland Clinic Florida

Brief Summary:
Overactive bladder (OAB) is a widespread condition characterized by urgency, urge incontinence, nocturia and excessive urinary frequency, affecting millions of people worldwide.(1) In two epidemiological studies, OAB was found in about 17% of American and European populations.(2)(3). This accounts for an estimated 33 million patients suffering from OAB in the USA. The disorder constitutes a psychological stress that impacts the patient's social life.

Condition or disease
Overactive Bladder Urinary Tract Infection

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Study Type : Observational
Actual Enrollment : 56 participants
Time Perspective: Prospective
Official Title: Identification of Urinary Cytokines in Patients With Overactive Bladder (OAB)
Study Start Date : March 2007
Actual Primary Completion Date : September 2008
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Overactive Bladder Patients
Urinary Tract Infection

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Twenty healthy women (control), 20 women suffering from overactive bladder and other 20 women suffering from UTI will be selected for the study. Each control will be age matched within +/- 5 years to patients.

Inclusion Criteria:

  • Group I (OAB patients)

    1. Women with OAB, ≥18 years and premenopausal non-menstruating, not on any anticholinergic for at least two weeks before enrollment in the study.
    2. Significant urgency,i.e., having moderate or severe urgency score.
    3. Having a score > 8 on the OAB-V8 questionnaire.
    4. Urinary frequency of more than 8/day, with urgency of urination, with or without urge incontinence.
    5. Negative screening urinalysis one month after documented UTI.
  • Group II (Control)

    1. Age-matched normal volunteers (≥18 years and premenopausal non-menstruating)
    2. No Urgency.
    3. OAB-8 score < 8.
    4. No UTI.
  • Group III (UTl)

    1. Age-matched
    2. ≥18 years and premenopausal non-menstruating women with culture proven UTI.

Exclusion Criteria:

  1. Treatable genitourinary conditions that could cause incontinence
  2. Hematuria
  3. Obstructive uropathy
  4. Patients diagnosed with vaginitis
  5. History of urothelial carcinoma
  6. Urinary tract infection (except group III)
  7. Pelvic radiation.
  8. Neurogenic bladder.
  9. Renal pathology.
  10. Stress urinary incontinence.
  11. Medications.
  12. Recent history of Botox injection in the bladder (Within the last year).

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): NCT00868621

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United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Cleveland Clinic Florida
Astellas Pharma US, Inc.
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Principal Investigator: Gamal Ghoniem, MD Cleveland Clinic Florida

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Responsible Party: Astellas Pharma, US Inc, Cleveland Clinic Florida Identifier: NCT00868621    
Other Study ID Numbers: IRB 8848
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Additional relevant MeSH terms:
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Urinary Tract Infections
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations