Trial Outcomes & Findings for Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients (NCT NCT01108757)

Results Overview

Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as \>100,000 colony forming units/mL

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

52 participants

Primary outcome timeframe

7 days following catheter removal

Results posted on

2017-10-18

Participant Flow

A total of 52 subjects were recruited.

Participant milestones

Participant milestones
Measure	Drug Bactrim: Bactrim DS BID for 3 days	Placebo Placebo: Corn starch capsules
Overall Study STARTED	26	26
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drug n=26 Participants Bactrim: Bactrim DS BID for 3 days Demographics data by group not available as this study was discontinued in 2013. Currently randomization data not available for reassessment.	Placebo n=26 Participants Placebo: Corn starch capsules	Total n=52 Participants Total of all reporting groups
Age, Customized Mean Age	60 years STANDARD_DEVIATION 12.9 • n=5 Participants	58 years STANDARD_DEVIATION 13.0 • n=7 Participants	59 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	26 participants n=7 Participants	52 participants n=5 Participants
Body mass index	25.8 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants	27.2 kg/m^2 STANDARD_DEVIATION 4.3 • n=7 Participants	26.5 kg/m^2 STANDARD_DEVIATION 3.5 • n=5 Participants

PRIMARY outcome

Timeframe: 7 days following catheter removal

Population: Study terminated early.

Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as \>100,000 colony forming units/mL

Outcome measures

Outcome measures
Measure	Drug n=26 Participants Bactrim: Bactrim DS BID for 3 days	Placebo n=26 Participants Placebo: Corn starch capsules
Number of Participants With Urinary Tract Infection	6 Participants	6 Participants

Adverse Events

Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lynn Borzi

Cleveland Clinic

Phone: 2164453158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place