Phase 4
N=163
Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI)
Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01450800 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Urinary Tract Infections — 18; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nitrofurantoin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Tract Infections |
18; 10 | — |
| SECONDARY Other Risk Factors for UTI |
131; 25; 3 | — |
| SECONDARY Other Risk Factors for UTI |
131; 25; 3 | — |
| SECONDARY Other Risk Factors for UTI |
131; 25; 3 | — |
| SECONDARY Other Risk Factors for UTI |
131; 25; 3 | — |
| SECONDARY Other Risk Factors for UTI |
131; 25; 3 | — |
| SECONDARY Other Risk Factors for UTI |
131; 25; 3 | — |
| SECONDARY Other Risk Factors for UTI |
131; 25; 3 | — |
Summary
This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.
Eligibility Criteria
Inclusion Criteria
- Undergoing urogynecologic surgery
- Receive postoperative catheterization
Exclusion Criteria
- Age less than 21 years old
- Pregnancy
- Allergy, contraindication or intolerance to Nitrofurantoin
- Do not speak English
- Dependent on trans-urethral catheter to accomplish voiding preoperatively
- Undergoing interstim device placement, urethral diverticulum surgery or fistula surgery
- Sustain intraoperative urinary tract injury requiring postoperative catheterization
Data sourced from ClinicalTrials.gov (NCT01450800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.