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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00868621
Date of registration: 23/03/2009
Primary sponsor: Cleveland Clinic Florida
Public title: Urinary Cytokines in Patients With Overactive Bladder (OAB)
Scientific title: Identification of Urinary Cytokines in Patients With Overactive Bladder (OAB)
Date of first enrolment: March 2007
Target sample size: 56
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00868621
Study type:  Observational
Study design:  Time Perspective: Prospective  
Countries of recruitment
United States
Contacts
Name:   Gamal Ghoniem, MD
Address: 
Telephone:
Email:
Affiliation:  Cleveland Clinic Florida
Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Overactive Bladder
Urinary Tract Infection
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
IRB 8848
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Astellas Pharma US, Inc.
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