N/A N=60

Urinary Cytokines in Patients With Overactive Bladder (OAB)

Overactive Bladder · Urinary Tract Infection

Bottom Line

View on ClinicalTrials.gov: NCT00868621 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jul 2024

Primary outcome: Primary: Number of Participants With Elevated Cytokines (Levels of Pro-inflammatory) — 20; 20; 16 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: The Cleveland Clinic
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Elevated Cytokines (Levels of Pro-inflammatory)	20; 20; 16	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00868621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.