NCT03106103

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

3.8 years

First QC Date

June 10, 2014

Last Update Submit

April 4, 2017

Conditions

Female Stress Incontinence

Keywords

urodynamicscystitisprophylactic antibioticsbacteriuria

Outcome Measures

Primary Outcomes (1)

  • Incidence of symptomatic and asymptomatic bacteriuria after urodynamic study in women with urinary incontinence

    24 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 82 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women with urinary dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CystitisBacteriuria

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrinary Tract InfectionsInfections

Study Officials

  • Elizabeth Hirakauva, Doctor

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

June 10, 2014

First Posted

April 10, 2017

Study Start

February 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2014

Last Updated

April 10, 2017

Record last verified: 2017-04