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

NCT03127280 | Completed

• 1 other identifier: 14-38
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infections; Urinary Retention; Satisfaction

Keywords

urinary tract infections; postoperative voiding dysfunction; foley removal; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of urinary tract infection

  2-3 weeks after surgery

• Patient satisfaction

  2-3 weeks after surgery

• Voiding dysfunction

  Between 4 hours after surgery completion to 24 hours after surgery completion.

Study Arms (2)

Conventional Foley Care

NO INTERVENTION

Following surgery, the patient's Foley catheter is removed on the morning of post-operative day one.

Fast Tract Foley care

EXPERIMENTAL

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

Interventions

Fast Track foley removal OTHER

Foley catheter is removed at 4 hours after surgery

Fast Tract Foley care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only biological females are eligible for this study as the study is only investigating patients undergoing gynecologic surgery (e.g. hysterectomy)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Christ Hospital: lead

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Related Publications (13)

• 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.

  PMID: 17980238 BACKGROUND

• 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.

  PMID: 21460463 BACKGROUND

• 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.

  PMID: 21315996 BACKGROUND

• 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.

  PMID: 10679141 BACKGROUND

• 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.

  PMID: 8875302 BACKGROUND

• 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.

  PMID: 11868889 BACKGROUND

• 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.

  PMID: 10879567 BACKGROUND

• 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.

  PMID: 17517855 BACKGROUND

• 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.

  PMID: 18840084 BACKGROUND

• 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.

  PMID: 18840088 BACKGROUND

• 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.

  PMID: 24058309 BACKGROUND

• 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.

  PMID: 34184246 DERIVED

• 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.

  PMID: 31688528 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Urinary Retention; Personal Satisfaction; Patient Satisfaction

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Patrick Lang, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Physician

Model Details: Randomized control trial

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 25, 2017
• Study Start: November 4, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 14, 2018
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)