Can Investigators Reduce Urinary Catheter Use and Lower Urinary Tract Infection Among Women Undergoing Benign Gynecologic Surgery? (CAUTI)

This is a randomized comparative trial investigating two different catheter management strategies among post-gynecologic surgery patients. Women undergoing any benign gynecologic surgery wherein they are anticipated to stay at least overnight and in whom no prolapse or urinary tract surgery was concurrently performed, will be randomly assigned to either conventional urinary catheter care removal on post-operative day 1 or same day surgery urinary catheter removal. Patient satisfaction and lower urinary tract symptoms including urine culture and antibiotic use will be tracked across both cohorts over the 2 weeks following the index surgery.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Urinary Retention; Satisfaction
• Intervention / Treatment: Other: Fast Track foley removal

Detailed Description

METHODS:

This study will be conducted at The Christ Hospital. Informed consent will be obtained from the patients in the pre-operative care unit prior to administration of any medications. Candidates for the study will clearly understand consenting to enroll in the study includes not only the randomized assignment of urinary catheter care postoperatively but also a follow-up phone survey to be administered approximately 2 weeks after discharge. Patient reasons for not enrolling in the study will be recorded.

Study population All women presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study. Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation. Following application of the inclusion and exclusion criteria, postoperative urinary catheter care (conventional vs. fast track) will randomized upon arrive to the postoperative care unit (PACU). These patients will compose the study population.

Protocol:

Per routine anesthesia practice once a patient has met criteria for discharge from the PACU, and following randomization into either the conventional or fast track cohorts, the subject will either have immediate removal of the catheter with a trial of void or the catheter will remain in place over night per routine practice with a trial of void arranged at the time of discharge.

The trial of void protocol will consist of backfilling the existing catheter with 300cc of sterile saline (or to a volume the patient reports to be subjectively full) and recording her voided volume that should occur within 30 minutes. The patient's self-reported percent of normal force of stream will be recorded (0-100% in 10% increments) along with her voided volume. If the patient voids at least 150cc of the instilled volume OR reports at least a >50% of normal force of stream she will be considered to have passed the voiding trial. The patient will be scanned for residual urine volume following the next spontaneous void or any time she reports symptoms consistent with obstructed voiding.

Duration of catheter use will be determined as the time from placement in the operating room (time 0) to the time it is removed on the hospital ward. Time will be recorded in hours. Discharge from the hospital will occur per the attending physician's routine practice. At hospital discharge subjects will complete a brief survey recording bladder function before and during their hospitalization. Also included in this survey will be an assessment of their overall satisfaction with their catheter management and hospital stay. Institution standard practice is to obtain a urinalysis in the operating room on all patients anticipating an overnight stay. This urinalysis and any other urine studies obtained during the hospitalization will be extracted from the medical record. The number of subjects who fail the trial of voiding between cohorts will be collected from the electronic medical record (EMR). After discharge, subjects will be contacted by phone 2-3 weeks after the index surgery. At this call subjects will be administered a survey reviewing their post-surgery bladder function including symptoms of a bladder infection. A review of the patient's hospital record will also be conducted to identify any additional urine studies ordered during the 2-3 weeks following surgery.

Randomization protocol: Permuted block randomization will be used to ensure a balanced enrollment of patients in the clinical trial. Selecting a block size of 4 will ensure that for every four patients enrolled, 2 will be assigned to the "Fast-track" cohort and 2 will be assigned to the "Conventional" cohort. In order to effectively conceal the randomization sequence, investigators will use sequentially numbered, opaque sealed envelopes (SNOSE). It will not be feasible to blind the physician, nurse and patient in this study, they will all be aware of the randomized allocation assignment. The study personnel administering the postoperative telephone questionnaires will be blinded by simply not informing them of the group allocation of the patient. Plans to manage incomplete data between cohorts will include meeting with nursing managers and supervisors to ensure that questions are completed and to verify how to enter information into the EMR. At the completion of the study every effort will be made to have all patient questionnaire completed.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All women, over the age of 18, presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study.

Exclusion Criteria:

• Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Conventional Foley Care; Following surgery, the patient's Foley catheter is removed on the morning of post-operative day one.
EXPERIMENTAL: Fast Tract Foley care; Following surgery, the patient's Foley catheter is removed on post-operative day zero, four hours after the completion of surgery.	Other: Fast Track foley removal; Foley catheter is removed at 4 hours after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foley Duration	Determine the duration (in hours) of urinary catheter use between conventional urinary catheter care and "fast track" urinary catheter care among women undergoing benign gynecologic surgery not involving lower urinary tract surgery or pelvic organ prolapse repair.	Between 4 hours after surgery completion to 24 hours after surgery completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of urinary tract infection	Determine the number of women treated for a urinary tract infection between "conventional" urinary catheter care and "fast track" urinary catheter care over the 2 weeks following the index gynecologic surgery.	2-3 weeks after surgery
Patient satisfaction	Determine patient satisfaction among women exposed to conventional catheter care and "fast track" catheter care as determined by completion of a researcher designed survey, entitled "Satisfaction with Urinary Catheter management and Expectations for bladder function after discharge", prior to discharge.	2-3 weeks after surgery
Voiding dysfunction	Determine the numbers of women who fail a voiding trial between conventional catheter care and "fast track" catheter care.	Between 4 hours after surgery completion to 24 hours after surgery completion.

Collaborators and Investigators

• Sponsor: The Christ Hospital
• Investigators: Principal Investigator: Patrick Lang, MD, The Christ Hospital

Publications and helpful links

General Publications

• Saint S. Clinical and economic consequences of nosocomial catheter-related bacteriuria. Am J Infect Control. 2000 Feb;28(1):68-75. doi: 10.1016/s0196-6553(00)90015-4.
• Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
• Apisarnthanarak A, Rutjanawech S, Wichansawakun S, Ratanabunjerdkul H, Patthranitima P, Thongphubeth K, Suwannakin A, Warren DK, Fraser VJ. Initial inappropriate urinary catheters use in a tertiary-care center: incidence, risk factors, and outcomes. Am J Infect Control. 2007 Nov;35(9):594-9. doi: 10.1016/j.ajic.2006.11.007.
• Umscheid CA, Mitchell MD, Doshi JA, Agarwal R, Williams K, Brennan PJ. Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol. 2011 Feb;32(2):101-14. doi: 10.1086/657912.
• Chenoweth CE, Saint S. Urinary tract infections. Infect Dis Clin North Am. 2011 Mar;25(1):103-15. doi: 10.1016/j.idc.2010.11.005. Epub 2010 Dec 18.
• Jarvis WR. Selected aspects of the socioeconomic impact of nosocomial infections: morbidity, mortality, cost, and prevention. Infect Control Hosp Epidemiol. 1996 Aug;17(8):552-7. doi: 10.1086/647371.
• Tambyah PA, Knasinski V, Maki DG. The direct costs of nosocomial catheter-associated urinary tract infection in the era of managed care. Infect Control Hosp Epidemiol. 2002 Jan;23(1):27-31. doi: 10.1086/501964.
• Saint S, Veenstra DL, Lipsky BA. The clinical and economic consequences of nosocomial central venous catheter-related infection: are antimicrobial catheters useful? Infect Control Hosp Epidemiol. 2000 Jun;21(6):375-80. doi: 10.1086/501776.
• Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.
• Yokoe DS, Mermel LA, Anderson DJ, Arias KM, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Kaye KS, Klompas M, Lo E, Marschall J, Nicolle L, Pegues DA, Perl TM, Podgorny K, Saint S, Salgado CD, Weinstein RA, Wise R, Classen D. A compendium of strategies to prevent healthcare-associated infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S12-21. doi: 10.1086/591060.
• Lo E, Nicolle L, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Kaye KS, Klompas M, Marschall J, Mermel LA, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S41-50. doi: 10.1086/591066. No abstract available.
• Dziura JD, Post LA, Zhao Q, Fu Z, Peduzzi P. Strategies for dealing with missing data in clinical trials: from design to analysis. Yale J Biol Med. 2013 Sep 20;86(3):343-58. eCollection 2013 Sep.
• Lang P, Quezada Y, Whiteside J. Urinary Catheter Management Approaches Among Women Undergoing Benign Gynecologic Surgery: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2020 Dec 1;26(12):e73-e77. doi: 10.1097/SPV.0000000000000781.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2014
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): January 14, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (ACTUAL): April 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: urinary tract infections; patient satisfaction; postoperative voiding dysfunction; foley removal
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Urination Disorders; Infections; Communicable Diseases; Urinary Tract Infections; Urinary Retention
• Other Study ID Numbers: 14-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No