Incidence of Symptomatic and Asymptomatic Bacteriuria After Urodynamic Study in Women

April 4, 2017 updated by: Elizabeth Yukie Hirakauva, Federal University of São Paulo

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
217

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of symptomatic and asymptomatic bacteriuria after urodynamic study in women with urinary incontinence
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of São Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Hirakauva, Doctor, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EYH-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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