Incidence of Symptomatic and Asymptomatic Bacteriuria After Urodynamic Study in Women

Incidence of Symptomatic and Asymptomatic Bacteriuria After Urodynamic Study With or Without Antibiotic Prophylaxis in Women With Urinary Incontinence

Urodynamic Study (UDS) represents a series of agreed-upon clinical tests and is used to evaluate the functional status of the lower urinary tract, providing a pathophysiological basis for urinary symptoms. Urodynamic Study involves catheterization of the lower urinary tract. The prevalence of urinary tract infection after UDS ranges from 1,5% to 30 %.

Studies of prophylactic antibiotics for UDSs have offered data of contradictory and limited predictive values. Some investigators concluded that prophylactic antibiotics were valuable and others have not.

The objective of this study is to evaluate the efficacy of antibiotic prophylaxis before UDS in women, using different antibiotic regimens.

Study Overview

• Status: Completed
• Conditions: Female Stress Incontinence

Detailed Description

This study is randomized, double blind study was carried out in the Department of Gynecology at Sao Paulo Federal University from January 2009 to December 2012.

The patients were randomized in four groups: Group A received 500mg of levofloxacin, group B received placebo, group C received 80mg trimethoprim and 400mg sulfamethoxazole (SMZ-TMP) and group D received 100mg of nitrofurantoin. The tablets were administered 30 minutes before de UDS.

All patients were instructed to collect midstream urine sample to the microbiology laboratory 14 days after the UDS. Significant bacteriuria was considered when >1.000.000 organisms/mL of a single species was isolated.

All data were entered into Statistical Package for Social Sciences (SPSS) 16.0 for statistical analysis and graphic representation. Likelihood -ratio test and Fisher's exact test were used to compare the prevalence of significant bacteriuria after UDS in the different groups and Student's t-test and ANOVA test were used to compare continuous variables. To compare the groups regarding the BMI variable and parity, the model analysis of variance (ANOVA) was used, or if necessary, the nonparametric Kruskal-Wallis test and to compare the groups in relation to menopause variable, we used the Chi-square test. A significance level of 0.05 was established for statistical analysis.

• Study Type: Observational
• Enrollment (Actual): 217

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

women with urinary dysfunction

Description

• Inclusion Criteria: Women with 20 to 85 years old, clinical diagnosis of urinary incontinence with indication for urodynamic study, absence of genital prolapse or prolapse peak effort that does not exceed the hymen, absence of urinary tract infection
• Exclusion Criteria: Patients with diabetes mellitus, history of recurrence urinary tract infection, with genital prolapse that exceed de hymen, pregnant, kidney stone, allergy to antibiotics, use of urethral catheters delay

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Women with urinary incontinence; The patients were randomized in four groups: Group A received 500mg of levofloxacin, group B received placebo, group C received 80mg trimethoprim and 400mg sulfamethoxazole (SMZ-TMP) and group D received 100mg of nitrofurantoin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of symptomatic and asymptomatic bacteriuria after urodynamic study in women with urinary incontinence	24 months

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Elizabeth Hirakauva, Doctor, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: prophylactic antibiotics; urodynamics; cystitis; bacteriuria
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Tract Infections; Bacteriuria; Urinary Incontinence, Stress
• Other Study ID Numbers: EYH-2014