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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 19, 2013
CompletedFirst Posted
Study publicly available on registry
August 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedAugust 21, 2013
August 1, 2013
11 months
August 19, 2013
August 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Bacteriuria
Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.
2 -4 weeks
Secondary Outcomes (1)
Subjective urinary tract discomfort
2-4 weeks postoperatively
Other Outcomes (1)
Symptomatic urinary tract infection
2-4 weeks
Study Arms (2)
Straight catheterization (control)
OTHERThe control arm is the current practice at our hospital (to perform straight catheterization for short procedures).
No straight catheterization
ACTIVE COMPARATORThe experimental arm will void preoperatively and will not be straight catheterized intraoperatively. This is a change from the current practice at our hospital.
Interventions
Patient will receive the current standard practice of straight catheterization intraoperatively.
Patients will not be catheterized which is an experimental change from the current practice at our hospital.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily G Parent, D.O.
Abington Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- OB/GYN Resident Physician PGY-IV
Study Record Dates
First Submitted
August 19, 2013
First Posted
August 21, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2014
Last Updated
August 21, 2013
Record last verified: 2013-08