Nitrofurantoin Administration for the Prevention of Short-Term Catheter Associated Urinary Tract Infection After Pelvic Surgery
Condition: Catheter-Associated Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Nitrofurantoin 100 MG; Placebo Oral Tablet
Intervention description: Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days; Matching placebo
Intervention MeSH terms: Nitrofurantoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 164.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nitrofurantoin; Prolapse; Pelvic Organ Prolapse; Anti-incontinence procedure; Urinary retention; Urinary Tract Infection; Short-term catheterization

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