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Phase 4 N=164 Randomized Quadruple-blind Prevention

Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery

Catheter-Associated Urinary Tract Infection

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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