Reducing Postoperative Catheterization

March 15, 2018 updated by: University of North Carolina, Chapel Hill

Reducing Postoperative Catheterization After Urogynecology Surgery: A Randomized Trial

After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute retention experience urinary tract infections in the postoperative period (6, 7). Many women consider being discharged with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery(8). At this time there is no consensus within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best assess voiding function postoperatively. FPMRS providers both within the United States and around the world utilize a variety of void trial methods and varying criteria to determine adequacy of post-operative voiding efficiency (5).

The traditional backfill assisted void trial method involves the assessment of a postvoid residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently, there have been efforts to determine ways to avoid the assessment of a PVR as it is time-consuming and potentially exposes the patient to additional catheterizations (9, 10). Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead utilize a certain voided volume threshold to determine adequate voiding. However, to date, no one has directly studied this approach or compared the traditional backfill assisted void trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating a more efficient void trial method, the investigators hope improve patients' postoperative experience and reduce catheterization and risk of urinary tract infection (UTI).

This study aims to compare two void trial methodologies in order to help standardize post-operative care in the urogynecology population. This study also has potential to lead to an overall change in our field and improve the postoperative course for women across the country and abroad.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data Collection Demographic characteristics (i.e. age, race, body mass index, medical history) will be collected at the time of preoperative visit. On the day of surgery, operative data will be recorded on a standard form to document procedures performed, intra-operative complications (if any), EBL and operative time. Prior to discharge the randomized void trial will be preformed. Data regarding the void trial will be documented on a standard form and will include which void trial was performed, amount backfilled, amount voided, post void residual when assessed, and if the patient was discharged voiding spontaneously, with a Foley catheter or performing CISC. All subjects will be instructed to call our clinical office to report any urinary complaints and treatment for UTI. Information will be collected from electronic medical records regarding any office visits, urine cultures performed or treatment for UTI during this 6-week period. Participants will be called 1 week from the time of surgery to complete the Short-term Catheter Burden Questionnaire.

Pre-operative Visit The preoperative visit may occur up to 3 months prior to surgery. Patients electing to participate in the study will be consented in a private exam to protect confidentiality. Once consented the subjects will be assigned a subject identification number for study identification purposes, which will consist of "A" if the patient's surgery is performed at Rex Hospital or "B" if the patient's surgery is performed at Hillsborough. A number will then follow the letter.

Void Trial Protocols

  1. Traditional backfill assisted voiding trial (control): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL.
  2. The post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed.

If the participant fails the voiding trial through either method they will be discharged to home with an indwelling catheter or with clean intermittent self-catheterization (CISC) per the participants preference. Subjects with an indwelling catheter will return to clinic within 1-3 days for a repeat voiding trial using the same voiding trial guidelines. If the subject is discharged on clean intermittent self-catheterization (CISC) she will document her voided volumes and PVRs at home. Our nurse will then call the participant every 1-2 business days to determine when they can stop CISC (2 consecutive PVRs less than 100 mL). Nurses will document all information into a standardized template in EPIC per routine clinic protocol.

Follow-Up Participants will be scheduled for their post-operative appointment at the time of scheduling their surgery per usual protocol. They will be called 1 week after surgery to complete a questionnaire. The postoperative visit usually takes place approximately 6 weeks after surgery. Any additional visits or calls to Urogynecology clinic prior to their post-operative appointment will be documented in the electronic medical record per routine clinical practice.

All efforts will be made to ensure minimal loss to follow-up of participants. This plan may include efforts such as telephone follow-up or electronic medical record communication with the patient.

Week 1 Phone Call The patient will be called one week after their surgery to answer the questions from the Short-Term Catheter Burden Questionnaire.

Week 6 Visit (-2 weeks/+2 weeks) The primary outcome will be assessed at the time of the post-operative visit with confirmation of need for catheterization. At this visit the subject will also have the patient complete a questionnaire regarding catheter use.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7570
        • University Of North Carolina At Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

The study will include women scheduled for pelvic organ prolapse surgery and/or stress urinary incontinence surgery requiring a post-operative voiding trial.

  1. 18 years or older
  2. English speaking
  3. Documented PVR of less than 100mL prior to surgery obtained either during a previous clinic visit or at the time of their preoperative urodynamics evaluation.

Exclusion Criteria:

  1. Pregnancy
  2. Dependent on catheterization to void preoperatively
  3. Patient's undergoing fistula repair, sacral neuromodulation, urethral diverticulum/vaginal mass excision or mesh revision surgery
  4. Inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Traditional backfill assisted voiding trial
Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL.
EXPERIMENTAL: Post-void residual free voiding trial
The post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed.
Other: Post-void residual free voiding trial
Will proceed with voiding trial and assess bladder emptying based on voided amount without checking a post-void residual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperative catheterization
Time Frame: At the time of hospital discharge (0-1 days)
Rate of postoperative catheterization which is defined as failing the postoperative voiding trial requiring the patients to be discharged to home with a Foley catheter or using clean intermittent self-catheterization (CISC).
At the time of hospital discharge (0-1 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of catheterization
Time Frame: From the day of surgery to 6 weeks post op
The number of days the subjects use either an indwelling Foley catheter or clean intermittent self catheterization starting on day of surgery.
From the day of surgery to 6 weeks post op
Treatment of clinical-suspected or culture proven urinary tract infection
Time Frame: From the day of surgery to 6 weeks post op
Antibiotic therapy given for either empiric or culture-proven UTI within the 6 week postoperative period. Any UTI treatment provided within our clinic is routinely documented in the EMR with urine culture results available in laboratory results. Patients will also be instructed to have any records from treatment obtained outside the UNC system to be faxed to our research offices. At the 6 week postoperative visits participants will be asked as well whether they received any antibiotic treatment for UTI during the 6 week postoperative period.
From the day of surgery to 6 weeks post op
Time spent in the Post Anesthesia Care Unit (PACU).
Time Frame: 0-24 hours
PACU time will be defined as the time from when the patient leaves the OR and the time the patient is discharged from the PACU. This information is routinely recorded in the EMR by anesthesia and nursing staff. This secondary outcome will only be used in participants who are being discharged to home from the PACU.
0-24 hours
Short term catheter burden
Time Frame: 1 week
Short term catheter burden will be assess using a validated 6-item questionnaire that will be completed 1 week following surgery in patients who failed the post operative voiding trial and are sent home with either indwelling Foley catheter or performing CISC.
1 week
Number of post-operative patient calls and subsequent clinic visits.
Time Frame: From the day of surgery to 6 weeks post op
This will be calculated using electronic medical record documentation and will compare the number of post-operative patient calls and subsequent patient visits between the control and intervention group.
From the day of surgery to 6 weeks post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

North Carolina Translational and Clinical Sciences Institute

Investigators

  • Principal Investigator: Marcella G Willis-Gray, MD, UNC at Chapel Hill, Division of Female Pelvic Medicine and Reconstructive Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 17, 2017

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 2, 2017

First Posted (ESTIMATE)

January 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-2888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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