Urinary Cytokines in Patients With Overactive Bladder (OAB)

NCT00868621 | Completed Results DMC

• 1 other identifier: IRB 8848
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder (OAB) is a widespread condition characterized by urgency, urge incontinence, nocturia and excessive urinary frequency, affecting millions of people worldwide. In two epidemiological studies, OAB was found in about 17% of American and European populations. 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.

Conditions

Overactive Bladder; Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Elevated Cytokines (Levels of Pro-inflammatory)

  Used commercial human cytokine chip. If the study proved that certain cytokines are significantly present (p\<0.05 compared to a standard) in the urine of OAB patients, further research to study the effect of anticholinergic drugs on the level of these cytokines in urine will be conducted.

  18 months

Study Arms (3)

1

Control Group(CG)- Healthy age-matched volunteers with no urinary symptoms.

2

Overactive Bladder Patients Group(OAB)- Patients with urgency of urination.

3

Urinary Tract Infection Group(UTI)- Symptomatic patients with dysuria, urgency and frequency of urination with proven urine cultures of infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Group I (OAB patients)
• Women with OAB, ≥18 years and premenopausal non-menstruating, not on any anticholinergic for at least two weeks before enrollment in the study.
• Significant urgency,i.e., having moderate or severe urgency score.
• Having a score \> 8 on the OAB-V8 questionnaire.
• Urinary frequency of more than 8/day, with urgency of urination, with or without urge incontinence.
• Negative screening urinalysis one month after documented UTI.
• Group II (Control)
• Age-matched normal volunteers (≥18 years and premenopausal non-menstruating)
• No Urgency.
• OAB-8 score \< 8.
• No UTI.
• Group III (UTl)
• Age-matched
• ≥18 years and premenopausal non-menstruating women with culture proven UTI.

You may not qualify if:

• Treatable genitourinary conditions that could cause incontinence
• Hematuria
• Obstructive uropathy
• Patients diagnosed with vaginitis
• History of urothelial carcinoma
• Urinary tract infection (except group III)
• Pelvic radiation.
• Neurogenic bladder.
• Renal pathology.
• Stress urinary incontinence.
• Medications.
• Recent history of Botox injection in the bladder (Within the last year).

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (12)

• 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. doi: 10.1007/s00240-003-0339-9. Epub 2003 Jul 11.

  PMID: 14574533 BACKGROUND

• 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.

  PMID: 8558640 BACKGROUND

• Ninan GK, Jutley RS, Eremin O. Urinary cytokines as markers of reflux nephropathy. J Urol. 1999 Nov;162(5):1739-42.

  PMID: 10524926 BACKGROUND

• 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. doi: 10.1152/ajprenal.2000.278.6.F867.

  PMID: 10836974 BACKGROUND

• 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. doi: 10.1113/jphysiol.2004.071159. Epub 2004 Dec 2.

  PMID: 15576455 BACKGROUND

• 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. doi: 10.1016/S0022-5347(05)00977-8.

  PMID: 16600715 BACKGROUND

• 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. doi: 10.1016/S0022-5347(05)00992-4.

  PMID: 16600756 BACKGROUND

• 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. doi: 10.1097/01.ju.0000176793.50410.9e.

  PMID: 16217388 BACKGROUND

• 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. doi: 10.1002/nau.20253.

  PMID: 16673377 BACKGROUND

• 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. doi: 10.1111/j.1523-1755.2002.kid565.x.

  PMID: 12234320 BACKGROUND

• 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. doi: 10.1177/000456328702400118. No abstract available.

  PMID: 3827174 BACKGROUND

• 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. doi: 10.1089/089277903322145530.

  PMID: 12885361 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Limitations and Caveats

Small numbers of participants, results need to be verified by other methods (quantitative)

Results Point of Contact

• Title: Gamal M. Ghoniem, MD, FACS
• Organization: Cleveland Clinic Florida

ghonieg@ccf.org

954-659-5188

Study Officials

• Gamal Ghoniem, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: August 1, 2009
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)