Trial Outcomes & Findings for Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal (NCT NCT03447639)

Results Overview

Per NHSN defined catheter associated UTI (CAUTI) criteria

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

48-72 hours after catheter removal

Results posted on

2020-01-18

Participant Flow

Patients were recruited from the inpatient units of the hospital.

Participant milestones

Participant milestones
Measure	Povidone-Iodine Irrigation Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique	Standard of Care Catheter removal with no bladder irrigation
Overall Study STARTED	0	3
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Povidone-Iodine Irrigation Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique	Standard of Care n=3 Participants Catheter removal with no bladder irrigation	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	0 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants
Sex: Female, Male Female	0 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants
Sex: Female, Male Male	0 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	0 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants
Presence of urinary tract infection	0 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants

PRIMARY outcome

Timeframe: 48-72 hours after catheter removal

Population: Patients with an indwelling catheter meeting the study eligibility criteria

Per NHSN defined catheter associated UTI (CAUTI) criteria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days after catheter removal

Population: Study terminated due to low enrollment

Per National Healthcare Safety Network (NHSN) defined CAUTI criteria

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days after catheter removal

Population: Study terminated due to low enrollment

Per NHSN defined CAUTI criteria

Outcome measures

Outcome data not reported

Adverse Events

Povidone-Iodine Irrigation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

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

Director of Urology Research

Beaumont Hospital

Phone: 248.551.0804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place