Does Straight Catheterization in Short Gynecologic Procedures Cause Bacteriuria?

Sponsor
Abington Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01926756
Collaborator
(none)
200
1
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Straight catheterization
  • Procedure: No straight catheterization
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Intraoperative One-Time Catheterization in Short Gynecologic Procedures and Its Potential Effect on Symptomatic and Asymptomatic Bacteriuria
Study Start Date :
Jul 1, 2013
Anticipated Primary Completion Date :
Jun 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Postoperative Bacteriuria [2 -4 weeks]

    Urine cultures are obtained preoperatively (baseline), immediately postoperatively and 2 to 4 weeks postoperatively.

Secondary Outcome Measures

  1. Subjective urinary tract discomfort [2-4 weeks postoperatively]

Other Outcome Measures

  1. Symptomatic urinary tract infection [2-4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Abington Memorial Hospital Abington Pennsylvania United States 19001

Sponsors and Collaborators

  • Abington Memorial Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily G. Parent, D.O., OB/GYN Resident Physician PGY-IV, Abington Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01926756
Other Study ID Numbers:
  • AMH-Myers/Parent001
First Posted:
Aug 21, 2013
Last Update Posted:
Aug 21, 2013
Last Verified:
Aug 1, 2013
Keywords provided by Emily G. Parent, D.O., OB/GYN Resident Physician PGY-IV, Abington Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2013