Clinical trial NCT03009968: Reducing Postoperative Catheterization
Official title: Reducing Postoperative Catheterization After Urogynecology Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Urinary Incontinence
Pelvic Organ Prolapse
Urinary Tract Infections
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2017-01-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of postoperative catheterization
timeFrame: At the time of hospital discharge (0-1 days)
Secondary outcomes:
measure: Duration of catheterization
timeFrame: From the day of surgery to 6 weeks post op
measure: Treatment of clinical-suspected or culture proven urinary tract infection
timeFrame: From the day of surgery to 6 weeks post op
measure: Time spent in the Post Anesthesia Care Unit (PACU).
timeFrame: 0-24 hours
measure: Short term catheter burden
timeFrame: 1 week
measure: Number of post-operative patient calls and subsequent clinic visits.
timeFrame: From the day of surgery to 6 weeks post op
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC at Chapel Hill, Division of Female Pelvic Medicine and Reconstructive Surgery
name: Marcella G Willis-Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Willis-Gray MG, Wu JM, Field C, Pulliam S, Husk KE, Brueseke TJ, Geller EJ, Connolly A, Dieter AA. Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e256-e260. doi: 10.1097/SPV.0000000000000743.