Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?

Not Applicable

• Conditions: Postoperative Bacteriuria
• Interventions: Procedure: Straight catheterization; Procedure: No straight catheterization

• Registration Number: NCT01926756
• Lead Sponsor: Abington Memorial Hospital

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Status Verified: 2013-08
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-20
• Last Update Submitted: 2013-08-20
• Study First Posted: 2013-08-21
• Last Update Posted: 2013-08-21
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Straight catheterization (control)	Straight catheterization	The control arm is the current practice at our hospital (to perform straight catheterization for short procedures).
No straight catheterization	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Bacteriuria	2 -4 weeks	Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.

Secondary Outcome Measures

Name	Time	Method
Subjective urinary tract discomfort	2-4 weeks postoperatively

Trial Locations

Locations (1)

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States