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

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.

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