Female Stress IncontinenceNCT03106103
Incidence of Symptomatic and Asymptomatic Bacteriuria After Urodynamic Study in Women
An observational study of Female Stress Incontinence, run by Federal University of São Paulo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 82 years, women only
- Conditions the study is for
- Female Stress Incontinence
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Dec 2014
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women with urinary dysfunction
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Female Stress Incontinence
- Keywords
- urodynamics, cystitis, prophylactic antibiotics, bacteriuria
- Medical subject headings
- Cystitis, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic and asymptomatic bacteriuria after urodynamic study in women with urinary incontinence
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Yukie Hirakauva, Federal University of São Paulo
- Investigators
- Elizabeth Hirakauva, Doctor, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106103
- Sponsor's protocol ID
- EYH-2014
- Status last verified
- Apr 2017
- First submitted
- 10 Jun 2014
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Symptomatic and Asymptomatic Bacteriuria After Urodynamic Study With or Without Antibiotic Prophylaxis in Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03106103
- Acronym / sponsor ID
- EYH-2014
- Conditions
- Female Stress Incontinence
- Keywords
- urodynamics, cystitis, prophylactic antibiotics, bacteriuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with urinary dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of symptomatic and asymptomatic bacteriuria after urodynamic study in women with urinary incontinence
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Hirakauva, Doctor principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Female Stress Incontinence, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic and asymptomatic bacteriuria after urodynamic study in women with urinary incontinence (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.