Status:
COMPLETED
Urinary Cytokines in Patients With Overactive Bladder (OAB)
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Overactive Bladder
Urinary Tract Infection
Eligibility:
FEMALE
18+ years
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...
Detailed Description
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 epidemiologi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00868621
Start Date
March 1 2007
End Date
August 1 2009
Last Update
July 29 2024
Active Locations (1)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331