Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial

October 7, 2018 updated by: Sara Farag

Urinary Retention Rates After Immediate Removal of Foley Catheter Versus Backfill Void Trial Following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial

Acute urinary retention is a complication of hysterectomies that can result in bladder over-distension and long term bladder dysfunction. The incidence of acute urinary retention after total laparoscopic hysterectomy (TLH) has been reported to be anywhere between 4% and 34%. Studies have varied in the method of post-operative bladder challenge and the modality of hysterectomy included. Moreover, most of the published studies are retrospective chart reviews or prospective observational studies, with a lack of randomized controlled trials. Risk factors for urinary retention include type of anesthesia used, how the hysterectomy is performed, use of post-operative narcotics, pre-operative urinary retention, and possibly aggressive bladder dissection. With the increased trend towards same-day discharge following TLH, urinary retention may cause unnecessary patient distress and a worsened post-operative course. Standardization of post-hysterectomy bladder challenge and identification of risk factors for urinary retention may aid in preventing urinary retention or acute bladder dysfunction. The primary objective is to compare the rate of void trial failure after TLH with the backfill technique versus the autofill technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a randomized control trial. Patients undergoing total laparoscopic hysterectomy (TLH) for benign conditions will be invited and consented to participate in the study prior to the day of their surgery. Each patient will be contacted by one of the study investigators and presented with the study including the risks, benefits, and follow up requirements. She will be given the option to participate and if agrees, she will sign a consent form. All enrolled participants will have a post-void residual (PVR) checked and recorded in the clinic using the bladder scanner that is available to us. The enrolled participants will also be asked to complete the Patient Perception of Bladder Condition (PPBC) and the Incontinence Impact Questionnaire-Short Form (IIQ-7) and the completed forms will be collected by the research team (see attached "Preoperative participant questionnaire").9,10 Each consented participant will be randomized to receive a post-operative backfill void trial or an autofill void trial on the day of her surgery. The participant will not be told of her randomization group pre-operatively; however, the surgical team will be aware of the randomization.

On the surgical day, all enrolled participants will undergo standard registration and preoperative preparation by the staff pre-operative nurse, including placement of intravenous access line and administration of standard preoperative medications. Preoperative medications (unless contraindicated due to allergy or other medication interaction) include single dose prophylactic antibiotics given prior to surgical incision, Tylenol 1,000 mg PO, Dexamethasone 10 mg IV (unless the participant has diabetes), Celebrex 200 mg PO (unless patient has a sulfa allergy, is ≥ 65 years old, weighs ≥ 50 kg, or has a CCl >50ml/min), Ondansetron 4 mg IV, and Gabapentin 600 mg PO (300 mg PO if participant is ≥ 65 years old) given in the preoperative area.11,12 Participants with a preoperative Caprini score of 5 or greater will also receive Heparin 5000 units subcutaneously for deep vein thrombosis (DVT) prophylaxis.13 The participant will be taken to the operating room. Induction, intubation, and anesthesia will be administered according to standard practice by a dedicated group of anesthesia providers. Prior to surgical incision, preoperative prophylactic antibiotics will be administered. The participant will be positioned in the dorsal lithotomy position with the lower extremities in the Allen stirrups bilaterally and the bilateral upper extremities in a tucked position. Surgical sterile preparation and draping will be performed per usual technique. Vaginal antiseptic preparation will be performed with 10% Povidone-Iodine solution. A Foley catheter will be placed prior to the start of the surgical procedure. The hysterectomy will then proceed in the usual manner. After the specimen is removed from the pelvis and the vaginal cuff is closed, a cystoscopy may be performed at the discretion of each surgeon. At this time, the randomization envelope will be opened. Participants who randomize to the backfill void trial will remain with a Foley catheter in place or will have the Foley catheter replaced, in the case that a cystoscopy is performed. Patients who randomize to the autofill void trial will be given a 500 cc bolus of crystalloid by the anesthesia team prior to leaving the operating room. All skin incisions will be closed in a subcuticular fashion and sealed with skin adhesive.

The participant will emerge from anesthesia under routine monitoring and will be transferred to the post-anesthesia care unit (PACU) when meeting appropriate criteria per anesthesia discretion. A staff PACU nurse will care for the participant in the PACU administer narcotic medications as necessary and/or per participant request. Once the participants are awake and meeting criteria for discharge, the patients in the backfill group will undergo a void trial by a PACU nurse or by a doctor if the nurse is unavailable. About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured using a bladder scanner. If the PVR is greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.

The participants in the autofill void trial group will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured using a bladder scanner. If the PVR is greater than 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced. We anticipate that most of these patients will void spontaneously within 2 hours of arrival to the PACU. At two hours post-operatively, any patient who cannot void or does not have the urge to void will have a bladder scan. If the patient has more than 300 cc in the bladder, she will be allowed 1 more hour to void. If she cannot, a Foley catheter will be placed and she will be considered to have failed the void trial. If the patient has less than 300 cc in the bladder, another 500 cc of crystalloid bolus will be given and we will await void for another hour. At 3 hours post-operatively, these patients will undergo another bladder scan. Those with greater than 300 cc of urine in the bladder will receive a Foley catheter. Those with less than 300 cc of urine in the bladder will have a backfill void trial by placing the remaining amount of fluid into the bladder for a total volume of 300 cc. The rest of the void trial will be completed as per normal backfill void trial protocol.

The participants who have a replaced Foley catheter will receive education regarding usage of a leg bag and will be discharged home to return to the office the following business day where a repeat void trial will be performed using the backfill method as previously outlined. If participants are unable to be discharged home, they will be admitted overnight in the hospital with documented rationale. A backfill void trial will then be performed the following day. If participants fail the 2nd void trial, a Foley catheter will be replaced and will remain in place for 1 week, at which time a backfill void trial will be repeated once again in the office. If this void trial is failed as well, participants will be educated about and asked to perform self-catheterization at home and will follow up with Urogynecology.

All participants will be discharged home with uniform medication prescriptions and instructions for usage. The medications will include Ondansetron 4mg PO every 8 hours as needed for nausea/vomiting (quantity 12), Colace 100mg PO twice daily (quantity 60), scheduled Ibuprofen 600mg PO every 6 hours (quantity 30), scheduled Acetaminophen 650mg PO every 6 hours (quantity 30), and Oxycodone 5mg PO every 4 hours as needed for breakthrough pain (quantity 30). These prescriptions are based on recent anesthesia practice guidelines.14,15

At the post-operative visit 10-14 days after the surgery, the participants will be evaluated and examined in the office. They will be asked to complete a questionnaire which includes the IIQ-7, the PPBC, and a void trial satisfaction question (see attached "post-operative participant questionnaire"). Participants will also be asked if they obtained a Foley catheter outside of the hospital at any urgent care centers, other doctors' offices, or emergency rooms. Additionally, participants will be asked if they have any urinary problems including dysuria, hematuria, frequency, hesitancy, urgency, or incomplete emptying. If any urinary complaints exist, participants will be asked to provide a urine sample for testing by urinalysis and urine culture. Participants will be treated per physician preference. After treatment, participation in the study will be considered completed.

Study Type

Interventional

Enrollment (Actual)

84

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
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females at least 18 years of age
  • Understand and voluntarily sign an informed consent form
  • English-speaking (able to read and understand English)
  • Undergoing total laparoscopic hysterectomy for benign indication

Exclusion Criteria:

  • Undergoing concomitant procedures in addition to hysterectomy which may cause urinary dysfunction
  • Undergoing robotic-assisted laparoscopy or laparotomy
  • Known history of pre-operative urinary incontinence or retention
  • History of prior bladder or prolapse surgery
  • Neurologic or spinal cord injury affecting bladder function
  • Pregnant women
  • Evidence of gynecologic malignancy
  • Currently taking anticholinergic medications

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Autofill Void Trial
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Device: Void Trial using Foley catheter
A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
Other Names:
  • Bladder challenge
Active Comparator: Backfill Void Trial
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR > 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Device: Void Trial using Foley catheter
A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
Other Names:
  • Bladder challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Void Trial Failure Rate
Time Frame: post-operative day, about 4 hours post-surgery
The primary endpoint of this study will be to determine if the rate of void trial failure after total laparoscopic hysterectomy is different after the autofill method versus the backfill method.
post-operative day, about 4 hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Discharge
Time Frame: post-operative day, about 4 hours post-surgery
The time to discharge will be measured for each participant. This will be determined by calculating the time between arrival to the post-anesthesia care unit and the time of discharge using documentation from Epic and from the case report forms.
post-operative day, about 4 hours post-surgery
Number of Patients With Urinary Retention
Time Frame: 10-14 days post-surgery
After discharge, participants will be monitored for any encounters for urinary retention (in our hospital system) and will be asked at their 10-14 day post-operative visit if they had a Foley catheter placed outside the hospital. Additionally, any participant who fails their 2nd void trial will be noted. The incidence of urinary retention post-discharge will be determined using this data.
10-14 days post-surgery
Number of Participants With Post-Operative Urinary Tract Infection
Time Frame: up to 14 days post-surgery
Any participant diagnosed with a culture-proven urinary tract infection will be noted.
up to 14 days post-surgery
Quality of Bladder Function Using the Incontinence Impact Questionnaire
Time Frame: pre-surgery and 14 days post-surgery

The Incontinence Impact Questionnaire-7 will be used to determine if there are any changes to the participants' short term quality of life before and after surgery. The questionnaire includes 7 questions asking how the participant's bladder function has affected her:

  1. Ability to do household chores.
  2. Physical recreation
  3. Entertainment activities
  4. Ability to travel by car or bus more than 30 minutes from home
  5. Participation in social activities outside the home
  6. Emotional health
  7. Feeling frustrated

The patient scores each of the questions using the following scale:

0 - Not at all

  1. - Slightly
  2. - Moderately
  3. - Greatly

The scores were added and divided by 7 to obtain an average score for each participant. Hence the range of scores is 0 to 3 with 0 being the best and 3 being the worst.
pre-surgery and 14 days post-surgery
Patient Perception of Bladder Condition Score
Time Frame: presurgery and at 10-14 days post-surgery

The Patient Perception of Bladder Condition will be used to determine if there are any changes to the participants' perception of bladder function before and after surgery.

In this questionnaire, the participant answers one question as follows:

My bladder condition:

0 - Does not cause me any problems at all

  1. - Causes me very minor problems
  2. - Causes me some minor problems
  3. - Causes me (some) moderate problems
  4. - Causes me severe problems
  5. - Causes me many severe problems

The score was recorded for each patient. The range of possible scores were 0 to 5 with 0 being the best and 5 being the worst scores.
presurgery and at 10-14 days post-surgery
Number of Participants Satisfied or Very Satisfied With Void Trial Using 5 Point Lickert Scale
Time Frame: at 10-14 days post-surgery
Participant satisfaction level with the method of void trial will be collected at the 10-14 day post-operative visit and compared between the two methods of void trial.
at 10-14 days post-surgery

Collaborators and Investigators

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

Sponsor

Sara Farag

Investigators

  • Principal Investigator: Michael L Sprague, MD, Cleveland Clinic Florida

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)

May 16, 2017

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 7, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLA 17-020

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

Yes

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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