Trial Outcomes & Findings for Urinary Cytokines in Patients With Overactive Bladder (OAB) (NCT NCT00868621)

NCT ID: NCT00868621

Last Updated: 2024-07-29

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2024-07-29

Participant Flow

Urine samples from Patients with Uninary Track Infection(UTI)and OAB attending Cleveland Clinic Florida (CCF) clinics were entered after screening). Urine samples were collected from age-matched Volunteers.

Aliquots of urine were centrifuged, frozen and stored at -80 degrees celcius. Samples were shipped on dry ice to co-authors by overnight courier. Co-authors were blinded to which samples were OAB, control or UTI.

Participant milestones

Measure	Normal Patients - Control Healthy age-matched volunteers with no urinary symptoms	Overactive Bladder Patients Patients urgency if urination	Urinary Tract Infection Symptomatic patients with dysuria, urgency and frequency of urination with proven urine cultures of infection.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	16
Overall Study NOT COMPLETED	0	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Urinary Cytokines in Patients With Overactive Bladder (OAB)

Baseline characteristics by cohort

Measure	Normal Patients - Control n=20 Participants Healthy age-matched volunteers with no urinary symptoms	Overactive Bladder Patients n=20 Participants Patients urgency if urination	Urinary Tract Infection n=16 Participants Symptomatic patients with dysuria, urgency and frequency of urination with proven urine cultures of infection.	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	16 Participants n=5 Participants	56 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	27 years STANDARD_DEVIATION 4.5 • n=5 Participants	29 years STANDARD_DEVIATION 5 • n=7 Participants	26.5 years STANDARD_DEVIATION 6 • n=5 Participants	27.5 years STANDARD_DEVIATION 5 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	16 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	16 participants n=5 Participants	56 participants n=4 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Normal Patients - Control:Urine analysis showing no UTI Overactive Bladder Patients: Urgency of urination, but negative UTI Urinary Tract Infection: Symptoms + Positive urine culture

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.

Outcome measures

Measure	Normal Patients - Control n=20 Participants Healthy age-matched volunteers with no urinary symptoms	Overactive Bladder Patients n=20 Participants Patients urgency if urination	Urinary Tract Infection n=16 Participants Symptomatic patients with dysuria, urgency and frequency of urination with proven urine cultures of infection.
Number of Participants With Elevated Cytokines (Levels of Pro-inflammatory)	20 Participants	20 Participants	16 Participants

Adverse Events

Normal Patients - Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Overactive Bladder Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Urinary Tract Infection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gamal M. Ghoniem, MD, FACS

Cleveland Clinic Florida

Phone: 954-659-5188

Email: ghonieg@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place