Can Investigators Reduce Urinary Catheter Use and Lower Urinary Tract Infection Among Women Undergoing Benign Gynecologic Surgery?

NCT ID: NCT03127280

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-04
• Study Completion Date: 2018-01-14

Brief Summary

This is a randomized comparative trial investigating two different catheter management strategies among post-gynecologic surgery patients. Women undergoing any benign gynecologic surgery wherein they are anticipated to stay at least overnight and in whom no prolapse or urinary tract surgery was concurrently performed, will be randomly assigned to either conventional urinary catheter care removal on post-operative day 1 or same day surgery urinary catheter removal. Patient satisfaction and lower urinary tract symptoms including urine culture and antibiotic use will be tracked across both cohorts over the 2 weeks following the index surgery.

Detailed Description

METHODS:

This study will be conducted at The Christ Hospital. Informed consent will be obtained from the patients in the pre-operative care unit prior to administration of any medications. Candidates for the study will clearly understand consenting to enroll in the study includes not only the randomized assignment of urinary catheter care postoperatively but also a follow-up phone survey to be administered approximately 2 weeks after discharge. Patient reasons for not enrolling in the study will be recorded.

Study population All women presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study. Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation. Following application of the inclusion and exclusion criteria, postoperative urinary catheter care (conventional vs. fast track) will randomized upon arrive to the postoperative care unit (PACU). These patients will compose the study population.

Protocol:

Per routine anesthesia practice once a patient has met criteria for discharge from the PACU, and following randomization into either the conventional or fast track cohorts, the subject will either have immediate removal of the catheter with a trial of void or the catheter will remain in place over night per routine practice with a trial of void arranged at the time of discharge.

The trial of void protocol will consist of backfilling the existing catheter with 300cc of sterile saline (or to a volume the patient reports to be subjectively full) and recording her voided volume that should occur within 30 minutes. The patient's self-reported percent of normal force of stream will be recorded (0-100% in 10% increments) along with her voided volume. If the patient voids at least 150cc of the instilled volume OR reports at least a >50% of normal force of stream she will be considered to have passed the voiding trial. The patient will be scanned for residual urine volume following the next spontaneous void or any time she reports symptoms consistent with obstructed voiding.

Duration of catheter use will be determined as the time from placement in the operating room (time 0) to the time it is removed on the hospital ward. Time will be recorded in hours. Discharge from the hospital will occur per the attending physician's routine practice. At hospital discharge subjects will complete a brief survey recording bladder function before and during their hospitalization. Also included in this survey will be an assessment of their overall satisfaction with their catheter management and hospital stay. Institution standard practice is to obtain a urinalysis in the operating room on all patients anticipating an overnight stay. This urinalysis and any other urine studies obtained during the hospitalization will be extracted from the medical record. The number of subjects who fail the trial of voiding between cohorts will be collected from the electronic medical record (EMR). After discharge, subjects will be contacted by phone 2-3 weeks after the index surgery. At this call subjects will be administered a survey reviewing their post-surgery bladder function including symptoms of a bladder infection. A review of the patient's hospital record will also be conducted to identify any additional urine studies ordered during the 2-3 weeks following surgery.

Randomization protocol: Permuted block randomization will be used to ensure a balanced enrollment of patients in the clinical trial. Selecting a block size of 4 will ensure that for every four patients enrolled, 2 will be assigned to the "Fast-track" cohort and 2 will be assigned to the "Conventional" cohort. In order to effectively conceal the randomization sequence, investigators will use sequentially numbered, opaque sealed envelopes (SNOSE). It will not be feasible to blind the physician, nurse and patient in this study, they will all be aware of the randomized allocation assignment. The study personnel administering the postoperative telephone questionnaires will be blinded by simply not informing them of the group allocation of the patient. Plans to manage incomplete data between cohorts will include meeting with nursing managers and supervisors to ensure that questions are completed and to verify how to enter information into the EMR. At the completion of the study every effort will be made to have all patient questionnaire completed.

Conditions

Urinary Tract Infections; Urinary Retention; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Conventional Foley Care

Following surgery, the patient's Foley catheter is removed on the morning of post-operative day one.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Fast Tract Foley care

Following surgery, the patient's Foley catheter is removed on post-operative day zero, four hours after the completion of surgery.

Group Type: EXPERIMENTAL

Fast Track foley removal

Intervention Type: OTHER

Foley catheter is removed at 4 hours after surgery

Interventions

Fast Track foley removal

Foley catheter is removed at 4 hours after surgery

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All women, over the age of 18, presenting to The Christ Hospital for gynecologic surgery anticipated to require an at least 1 night stay and in whom would be expected to have an indwelling catheter overnight are eligible to participate in the study.

Exclusion Criteria

• Patients with a current urinary tract infection being treated with antibiotic(s), anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a history of chronic indwelling catheter use, a history of renal transplant or current dialysis use, or intraoperative lower urinary tract injury necessitating prolonged postoperative catheter use are to excluded from study participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Christ Hospital

OTHER

Sponsor Role: lead

Responsible Party

Patrick Lang

Fellow Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Lang, MD

Role: PRINCIPAL_INVESTIGATOR

The Christ Hospital

Locations

The Christ Hospital

Cincinnati, Ohio, United States

Countries

United States

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Other Identifiers

14-38

Identifier Type: -

Identifier Source: org_study_id