Trial Outcomes & Findings for Colonizing Neurogenic Bladders With Benign Flora (NCT NCT00371631)

NCT ID: NCT00371631

Last Updated: 2014-11-24

Results Overview

Bladder colonization was defined when (≥102 cfu/ml) of E. coli 83972 was detected in urine cultures for \> 3 days after catheter removal.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: > 3 days, up to 197 days
• Results posted on: 2014-11-24

Participant Flow

Participant milestones

Measure	Treatment Arm insertion of E. coli coated catheter Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Colonizing Neurogenic Bladders With Benign Flora

Baseline characteristics by cohort

Measure	Treatment Arm n=13 Participants insertion of E. coli coated catheter Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
Age, Customized Age	56 years n=5 Participants
Sex/Gender, Customized Male	13 participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
average time since injury	15 years n=5 Participants

PRIMARY outcome

Timeframe: > 3 days, up to 197 days

Bladder colonization was defined when (≥102 cfu/ml) of E. coli 83972 was detected in urine cultures for > 3 days after catheter removal.

Outcome measures

Measure	Treatment Arm n=13 Participants insertion of E. coli coated catheter Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
Bladder Colonization	62 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Symptomatic UTI was defined as significant bacteriuria (≥105 cfu/ml) and pyuria (>10 WBC/hpf) plus ≥1 of the following signs and symptoms for which no other etiology could be identified: fever (oral temperature >100°F), suprapubic or flank discomfort, bladder spasm, change in voiding habits, increased spasticity, or worsening dysreflexia. The rate of UTI (number) was calculated by dividing the total number of patient days by the total number of UTIs.

Outcome measures

Measure	Treatment Arm n=13 Participants insertion of E. coli coated catheter Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
The Rate of Symptomatic UTI While Colonized pre-study rate of UTI	2.27 UTI/per subject year
The Rate of Symptomatic UTI While Colonized post-study rate of UTI	1.98 UTI/per subject year

Adverse Events

Treatment Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Arm n=13 participants at risk insertion of E. coli coated catheter Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
Renal and urinary disorders Urinary Tract Infection	7.7% 1/13 • Number of events 1
Renal and urinary disorders Groin pain	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Dysreflexia	7.7% 1/13 • Number of events 1

Additional Information

Dr. Barbara Trautner, MD, PhD

Michael E. DeBakey Veterans Affairs

Phone: 713-440-4438

Email: barbara.trautner@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place