NCT03447639

Brief Summary

Over the last decade, there has been great emphasis on reducing the incidence of hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 29, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2018

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 24, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

February 8, 2018

Results QC Date

April 4, 2019

Last Update Submit

January 9, 2020

Conditions

Catheter; Infection (Indwelling Catheter)Catheter InfectionCatheter-Related InfectionsCatheter BacteraemiaUrinary Tract Infections

Keywords

Catheter associated UTIPovidine iodineBladder Irrigation

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Urinary Tract Infection (UTI)

    Per NHSN defined catheter associated UTI (CAUTI) criteria

    48-72 hours after catheter removal

Secondary Outcomes (2)

  • Diagnosis of UTI at 7 Days

    7 days after catheter removal

  • Diagnosis of UTI at 28 Days

    28 days after catheter removal

Study Arms (2)

Povidone-Iodine Irrigation

EXPERIMENTAL

Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal

Drug: Povidone-iodine irrigation

Standard of Care

NO INTERVENTION

Catheter removal with no bladder irrigation

Interventions

Povidone-iodine irrigationDRUG

Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique

Also known as: Betadine
Povidone-Iodine Irrigation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
  • Male
  • Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal

You may not qualify if:

  • Patients planned for discharge with an indwelling catheter in place
  • Patients unable to report urinary symptoms accurately
  • Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
  • Clinical signs or symptoms of urinary tract infection at the time of consent
  • Patients currently being treated for UTI
  • Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole.
  • Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
  • Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
  • Patients unable to comply with study requirements
  • Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

InfectionsCatheter-Related InfectionsUrinary Tract Infections

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Director of Urology Research
Organization
Beaumont Hospital
Deborah.Hasenau@Beaumont.org
248.551.0804

Study Officials

  • Jay Hollander, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 2 arm parallel study with 1 to 1 randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Urologist

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 27, 2018

Study Start

March 29, 2018

Primary Completion

October 18, 2018

Study Completion

October 22, 2018

Last Updated

January 18, 2020

Results First Posted

April 24, 2019

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)