Trial Outcomes & Findings for Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI) (NCT NCT01450800)

Results Overview

The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

163 participants

Primary outcome timeframe

three weeks post-operative

Results posted on

2017-02-13

Participant Flow

Patients who received postoperative transurethral catheterization after surgery for pelvic organ prolapse, urinary incontinence, or both by the Division of Urogynecology at Duke University Medical Center from 8/2011 through 2/2013 were identified, recruited and enrolled after providing written informed consent at a routine pre-operative visit.

Randomization occurred within a few hours after surgery. Participants were excluded prior to randomization if they sustained intraoperative injury to the urinary tract requiring prolonged catheterization, or if they passed an immediate void trial on day of surgery (as these participants did not receive additional postoperative catheterization).

Participant milestones

Participant milestones
Measure	Nitrofurantoin Randomized to nitrofurantoin 100mg daily for each day of catheterization for up to 7 days	Placebo Randomized to placebo 1 tablet daily for each day of catheterization for up to 7 days
Overall Study STARTED	82	81
Overall Study COMPLETED	81	78
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Nitrofurantoin Randomized to nitrofurantoin 100mg daily for each day of catheterization for up to 7 days	Placebo Randomized to placebo 1 tablet daily for each day of catheterization for up to 7 days
Overall Study Protocol Violation	1	3

Baseline Characteristics

Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitrofurantoin n=82 Participants Participants randomized to receive antibiotics instructed to take nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization	Placebo n=81 Participants Participants randomized to receive placebo instructed to take placebo 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization	Total n=163 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants	55 Participants n=7 Participants	113 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 13 • n=5 Participants	57 years STANDARD_DEVIATION 13 • n=7 Participants	57 years STANDARD_DEVIATION 13 • n=5 Participants
Gender Female	82 Participants n=5 Participants	81 Participants n=7 Participants	163 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	81 participants n=7 Participants	163 participants n=5 Participants

PRIMARY outcome

Timeframe: three weeks post-operative

Population: Intent-to-treat analysis

The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.