Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?

Postoperative Bacteriuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01926756
• Other study ID #: AMH-Myers/Parent001
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2013
• Last updated: August 20, 2013
• Start date: July 2013

Study information

• Verified date: August 2013
• Source: Abington Memorial Hospital
• Contact: Emily G Parent, D.O.
• Phone: 215-481-7663
• Email: eparent[@]amh.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteriuria
• Postoperative Bacteriuria

Intervention

Procedure:
• Straight catheterization
Patient will receive the current standard practice of straight catheterization intraoperatively.
• No straight catheterization
Patients will not be catheterized which is an experimental change from the current practice at our hospital.

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abington Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptomatic urinary tract infection		2-4 weeks	No
Primary	Postoperative Bacteriuria	Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.	2 -4 weeks	No
Secondary	Subjective urinary tract discomfort		2-4 weeks postoperatively	No