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Urinary Cytokines in Patients With Overactive Bladder (OAB)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Cleveland Clinic Florida.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00868621
First Posted: March 25, 2009
Last Update Posted: March 25, 2009
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.
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Cleveland Clinic Florida
  Purpose
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
Overactive Bladder Urinary Tract Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Identification of Urinary Cytokines in Patients With Overactive Bladder (OAB)

Resource links provided by NLM:


Further study details as provided by Cleveland Clinic Florida:

Enrollment: 56
Study Start Date: March 2007
Estimated Study Completion Date: June 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Control
2
Overactive Bladder Patients
3
Urinary Tract Infection

  Show Detailed Description

  Eligibility

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:   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.
Criteria

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).
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00868621


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

Publications:
Abdel-Mageed AB, Bajwa A, Shenassa BB, Human L, Ghoniem GM. NF-kappaB-dependent gene expression of proinflammatory cytokines in T24 cells: possible role in interstitial cystitis. Urol Res. 2003 Oct;31(5):300-5. Epub 2003 Jul 11. Erratum in: Urol Res. 2004 May;32(2):133.
de Reijke TM, de Boer EC, Kurth KH, Schamhart DH. Urinary cytokines during intravesical bacillus Calmette-Guerin therapy for superficial bladder cancer: processing, stability and prognostic value. J Urol. 1996 Feb;155(2):477-82.
Ninan GK, Jutley RS, Eremin O. Urinary cytokines as markers of reflux nephropathy. J Urol. 1999 Nov;162(5):1739-42.
Lewis SA. Everything you wanted to know about the bladder epithelium but were afraid to ask. Am J Physiol Renal Physiol. 2000 Jun;278(6):F867-74. Review.
Chopra B, Barrick SR, Meyers S, Beckel JM, Zeidel ML, Ford AP, de Groat WC, Birder LA. Expression and function of bradykinin B1 and B2 receptors in normal and inflamed rat urinary bladder urothelium. J Physiol. 2005 Feb 1;562(Pt 3):859-71. Epub 2004 Dec 2.
Kanai A, de Groat W, Birder L, Chai T, Hultgren S, Fowler C, Fry C. Symposium report on urothelial dysfunction: pathophysiology and novel therapies. J Urol. 2006 May;175(5):1624-9.
Kim JC, Park EY, Seo SI, Park YH, Hwang TK. Nerve growth factor and prostaglandins in the urine of female patients with overactive bladder. J Urol. 2006 May;175(5):1773-6; discussion 1776.
Yokoyama O, Yusup A, Miwa Y, Oyama N, Aoki Y, Akino H. Effects of tolterodine on an overactive bladder depend on suppression of C-fiber bladder afferent activity in rats. J Urol. 2005 Nov;174(5):2032-6.
Yokoyama O, Yusup A, Oyama N, Aoki Y, Tanase K, Matsuta Y, Miwa Y, Akino H. Improvement of bladder storage function by alpha1-blocker depends on the suppression of C-fiber afferent activity in rats. Neurourol Urodyn. 2006;25(5):461-7.
Thongboonkerd V, McLeish KR, Arthur JM, Klein JB. Proteomic analysis of normal human urinary proteins isolated by acetone precipitation or ultracentrifugation. Kidney Int. 2002 Oct;62(4):1461-9.
Townsend JC, Sadler WA, Shanks GM. The effect of storage pH on the precipitation of proteins in deep frozen urine samples. Ann Clin Biochem. 1987 Jan;24 ( Pt 1):111-2.
Tadros Y, Ruiz-Deya G, Crawford BE, Thomas R, Abdel-Mageed AB. In vivo proteomic analysis of cytokine expression in laser capture-microdissected urothelial cells of obstructed ureteropelvic junction procured by laparoscopic dismembered pyeloplasty. J Endourol. 2003 Jun;17(5):333-6.

Responsible Party: Astellas Pharma, US Inc, Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT00868621     History of Changes
Other Study ID Numbers: IRB 8848
First Submitted: March 23, 2009
First Posted: March 25, 2009
Last Update Posted: March 25, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Tract Infections
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Infection


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