Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?

Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria

This is a prospective randomized controlled trial to look into the reduction of catheter associated urinary tract infections in the postoperative period. It will specifically look at short gynecologic procedures such as D&C (dilation and curettage), hysteroscopies and LEEP procedures and the need to perform intraoperative catheterization. If a patient urinates immediately before a short operation then there is no need to drain the bladder with a catheter during the procedure. The investigators hypothesize that eliminating catheterization during these short procedures may decrease postoperative urinary tract infections. The hope is that this study would provide evidence to support a change in practice.

Study Overview

• Status: Unknown
• Conditions: Postoperative Bacteriuria
• Intervention / Treatment: Procedure: Straight catheterization; Procedure: No straight catheterization

Detailed Description

The majority of research currently concentrates on indwelling catheters rather than one-time catheterization. Current practice at our institution in the gynecologic operating room is to perform a one time catheterization on patient's undergoing short procedures, yet it is unclear if this is a necessary intervention. If patients are asked to void immediately before their procedure it would eliminate the need for intra-operative catheterization and eliminate a potential source of infection.

The study is designed to determine whether routine catheterization prior to a minor OB/GYN procedure causes symptomatic or asymptomatic bacteria in the urine. Current practice is one-time catheterization of patients undergoing minor OB/GYN procedures prior to the beginning of the procedure. The investigators hypothesize that this causes asymptomatic or symptomatic bacteriuria.

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

Contacts and Locations

• Study Contact: Name: Emily G Parent, D.O.; Phone Number: 215-481-7663; Email: eparent@amh.org
• Study Contact Backup: Name: Victoria Myers, M.D.; Phone Number: 215-481-8379; Email: vmyers@amh.org

Study Locations

• United States
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Recruiting
      • Abington Memorial Hospital
      • Contact: Emily Parent, D.O.; Phone Number: 215-481-7663; Email: eparent@amh.org
      • Contact: Joel Polin, M.D.; Phone Number: 215-481-4211; Email: JPolin@amh.org

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:

• The patient must be 18 years of age or older.
• The patient must be female.
• The patient must be undergoing a same-day gynecologic procedure where catheterization is usually performed.
• The patient must have general anesthesia or monitored anesthesia care (MAC). This includes IV sedation.

Exclusion Criteria:

• The patient cannot be undergoing intermittent one-time catheterization.
• The patient can not have had an indwelling catheter placed in the past 6 months.
• The patients cannot have a concomitant pelvic infection.
• The procedure cannot require spinal anesthesia.
• The patient cannot be taking immunosuppressive medications.
• The patient cannot be taking antibiotics and/or suppressive therapy for chronic urinary tract infections.
• The patient cannot receive pre-operative or intra-operative antibiotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Straight catheterization (control); The control arm is the current practice at our hospital (to perform straight catheterization for short procedures).	Procedure: Straight catheterization; Patient will receive the current standard practice of straight catheterization intraoperatively.
Active Comparator: No straight catheterization; The experimental arm will void preoperatively and will not be straight catheterized intraoperatively. This is a change from the current practice at our hospital.	Procedure: No straight catheterization; Patients will not be catheterized which is an experimental change from the current practice at our hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Bacteriuria	Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.	2 -4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Subjective urinary tract discomfort	2-4 weeks postoperatively

Other Outcome Measures

Outcome Measure	Time Frame
Symptomatic urinary tract infection	2-4 weeks

Collaborators and Investigators

• Sponsor: Abington Memorial Hospital
• Investigators: Principal Investigator: Emily G Parent, D.O., Abington Memorial Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 20, 2013
• First Posted (Estimate): August 21, 2013

Study Record Updates

• Last Update Posted (Estimate): August 21, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: urinary tract infections; iatrogenic; bacteriuria; straight catheterization
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria
• Other Study ID Numbers: AMH-Myers/Parent001