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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00868621 |
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Date of registration:
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23/03/2009 |
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Primary sponsor: |
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Public title:
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Urinary Cytokines in Patients With Overactive Bladder (OAB)
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Scientific title:
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Identification of Urinary Cytokines in Patients With Overactive Bladder (OAB) |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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56 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00868621 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Gamal Ghoniem, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cleveland Clinic Florida |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Overactive Bladder
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Urinary Tract Infection
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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