The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAtlantic Health System
About this trial
The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled to undergo a urethral bulking procedure
Age 18 ≥ over
Disqualifiers
History of recurrent urinary tract infections
Known history of urinary retention
Allergies or contraindications to multiple antibiotics
Inability to tolerate oral antibiotics
Trial design
Design model
Parallel
Treatments tested in this trial
Prophylactic antibiotics
Other interventionThese participants will be given a single dose of an oral antibiotic prior to the procedure.
No antibiotics
Other interventionThese participants will not be given an antibiotic prior to the procedure.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Antibiotic GroupExperimental treatment 1 intervention
Group B: No antibiotic groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Rate of urinary tract infection (UTI)
The rate of UTI based on symptoms and a positive urine culture
Time frame
Within 4 weeks after the procedureSecondary outcomes
1
Rate of postoperative urinary retention
The rate of postoperative urinary retention
Time frame
Within 4 weeks after the procedure2
Rates of other postoperative complications
The rate of other complications (bleeding, discomfort, etc)
Time frame
Within 4 weeks after the procedureSponsors and contacts
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Source ClinicalTrials.gov