Clinical trial NCT01926756: Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?
Official title: Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Bacteriuria
Keywords: bacteriuria
straight catheterization
urinary tract infections
iatrogenic
Lead sponsor: Abington Memorial Hospital
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Bacteriuria
timeFrame: 2 -4 weeks
Secondary outcomes:
measure: Subjective urinary tract discomfort
timeFrame: 2-4 weeks postoperatively
Other outcomes:
measure: Symptomatic urinary tract infection
timeFrame: 2-4 weeks
Locations:
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
Study officials:
affiliation: Abington Memorial Hospital
name: Emily G Parent, D.O.
role: PRINCIPAL_INVESTIGATOR
References: