Phase 4
N=164
Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery
Catheter-Associated Urinary Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT03287089 ↗Enrolled (actual)
164
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: UTI — 15; 14 Participants — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nitrofurantoin 100 MG (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY UTI |
15; 14 | 0.84 |
| SECONDARY Adverse Events |
0; 0; 5; 2; 0; 0 | 0.44 |
| SECONDARY Medication Compliance |
0.95; 0.96 | 0.68 |
Summary
The specific aim of this randomized double-blind placebo-controlled trial is to evaluate the efficacy of administration of nitrofurantoin prophylaxis after catheter discontinuation for the prevention of catheter-associated urinary tract infections in patients with postoperative short-term catheterization following pelvic reconstructive surgery and/or urinary incontinence surgery.
Patients that undergo pelvic organ prolapse and/or urinary incontinence surgery and fail their post-operative voiding trial will be included in the study. Upon successfully passing and in-office voiding trial at the time of catheter removal, they will be randomized to either nitrofurantoin 100mg twice daily or an identical appearing placebo capsule twice daily for 5 days following catheter removal. The primary outcome will be the treatment of clinically suspected and/or culture-proven UTI within 30 days of surgery. Secondary outcomes include adverse events associated with nitrofurantoin use and medication compliance.
Primary and secondary outcomes will be evaluated with Student t test and chi squared or Fisher exact test as appropriate. Assuming a decrease in symptomatic UTIs attributable to nitrofurantoin prophylaxis from 32% to 14%, with 80% power, and a two-sided alpha of 0.05, we should recruit a total of 164 patients.
Eligibility Criteria
Inclusion Criteria
- Age greater than 18
- Creatinine clearance greater than 30 ml/min
- Failed postoperative hospital voiding trial
Exclusion Criteria
- Pregnant
- History of glucose-6-phosphate dehydrogenase deficiency
- History of renal insufficiency, renal transplant, or nephropathy
- Allergy to nitrofurantoin
- History of recurrent UTI (defined as greater than two culture-proven infections in six months or three infections in one year)
- Urinary Tract Infection (UTI) within 14 days one month of surgery
- Non-English speaking
- Urinary tract infection while Foley catheter is in place
- On antibiotic therapy for other non-urological reasons
- Sustained intraoperative bladder injury requiring prolonged catheterization greater than 5 days
- Undergoing mesh excision from within the bladder, fistula repair, cystotomy repair, urethral diverticulectomy, sacral neuromodulation, urethral surgery, or any other procedure requiring prolonged catheterization and bladder decompression
- Placement of a suprapubic catheter
- Participants that request intermittent self-catheterization
- Neurologic conditions affecting urinary tract system and normal voiding mechanisms
- History of hepatic impairment due to prior nitrofurantoin use
- Inability to provide consent/decisionally impaired
- More than two in-office voiding trials
Data sourced from ClinicalTrials.gov (NCT03287089). 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.