Clinical trial NCT05353400: At Home Early vs. Delayed Catheter Removal Following Failed Postoperative Voiding Trial: a Randomized Trial
Official title: At Home Early vs. Delayed Catheter Removal Following Failed Postoperative Voiding Trial: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Retention Postoperative
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to investigate whether patients who self-remove their indwelling transurethral catheters on POD 1 have similar rates of postoperative catheter reinsertion for urinary retention (within the first 7 days after surgery) compared with those who undergo catheter self-removal on POD 3.

Detailed description: Studies estimate the rate of post-operative urinary retention (POUR) after pelvic reconstructive surgery to be between 2.5-43% in all patients1. Consequently, patients undergoing pelvic reconstructive surgery will commonly undergo an assessment of voiding function prior to discharge. Patients who do not successfully complete a voiding trial (VT) are typically discharged from the hospital with a transurethral indwelling catheter. The preferred length of time the catheter remains in place postoperatively, however, varies widely (1 to 7 days) amongst pelvic reconstructive surgeons2-4.

Over the past few years, Enhanced Recovery After Surgery (ERAS) protocols have been adopted for patients undergoing reconstructive vaginal and minimally invasive (laparoscopic or robotic) surgery with increased focus on patient centered outcomes5. The benefits of ERAS in pelvic reconstructive surgery often allow for patients to be discharged home from the hospital the same day of their surgery. Unfortunately, same day discharge is associated with higher rates of postoperative voiding dysfunction and subsequent discharge home with a urinary catheter, with an incidence reported as high as 33.9-36%2,6. This increased rate of postoperative urinary retention has been reflected in our patient population. Prior to the implementation of ERAS in our pelvic reconstructive surgery division at Atrium Health, the rate of discharge home with a urinary catheter after failed VT on postoperative day (POD) 1 was 28%. With the implementation of an ERAS protocol and same day discharge (POD 0), the rate climbed to 43%7. Consequently, a higher percentage of postoperative patients have required a second VT prior to catheter discontinuation. This has necessitated additional clinical visits with a nurse or other provider, further stretching our clinical staff and obligating patients to make an additional trip to the clinic for a repeat postoperative VT.

Recent evidence supports the safety and improved patient experience in patients who self-discontinue a transurethral urinary catheter. In the study by Shatkin-Margolis et al., patients who had undergone pelvic reconstructive surgery were randomized to either self- discontinuation or in office discontinuation overseen by medical personnel one week after surgery8. This study found that self-discontinuation of transurethral catheter was non-inferior to office-based discontinuation following pelvic reconstructive surgery. Additionally, the authors found that self-discontinuation resulted in fewer patient encounters and improved patient experience.

Given this supportive evidence of safe catheter self-discontinuation and our practice's desire to improve patient satisfaction while decreasing clinical burden, we have adopted a practice where the patient self-removes their urinary catheter on the same day that a typical in-office VT would occur (POD 3). During preoperative counseling visits, our patients receive structured handouts with pictorial and descriptive language explaining how to safely self-remove a transurethral catheter (Figure 1). If VT failure should occur, the post anesthesia care unit (PACU) nursing staff review the instructions once again with the patient and the patient's support person(s) prior to discharge. Patients are told to call the office with any symptoms or concerns. Additionally, a nurse from our practice follows up with the patient via telephone on POD 1.

Patient experience following surgery is an important patient centered outcome. Unfortunately, being discharged home with an indwelling transurethral catheter for any amount of time is often perceived by patients as a postoperative complication and is a source of dissatisfaction in patients undergoing pelvic reconstructive surgery9-10. Therefore, decreasing the dissatisfaction surrounding postoperative catheter use improves the patient experience. Several studies have evaluated early postoperative catheter discontinuation after pelvic reconstructive surgery in an effort to limit the length of time that a catheter is in place. In a randomized controlled trial of immediate versus POD1 catheter removal in patients undergoing minimally invasive pelvic reconstructive surgery by Vallabh-Patel et al. the rate of POUR on POD 0 was 31%; however, the rate on POD 1 was 4.5%2. Similar low rates of POUR were noted in a prospective cohort trial performed by Botros et al. which evaluated the effects of a mid-urethral sling at the time of robotic sacrocolpopexy and noted a POD 1 retention rate of 1% in this patient population11. Finally, in a retrospective cohort study incorporating both laparoscopic and vaginal pelvic reconstructive surgery performed by El Hiraki et al., the rate of failed VT within 23 hours of surgery was 11.1% for minimally invasive group and 34% for the vaginal surgery group12. This limited body of evidence suggests that a voiding trial as early as postoperative day 1 seems to yield a voiding trial pass rate of 1-34% in pelvic reconstructive surgery patients.

Our group aims to optimize urinary catheter management for both the patient and the clinical staff in the postoperative period when patients are discharged on the same day of their surgery with a transurethral urinary catheter. We are proposing a non-inferiority trial comparing at home POD 1 catheter removal with at home POD 3 catheter removal (our current standard of practice).

Eligibility criteria: Inclusion Criteria:

* English speaking Age 18+ Undergoing pelvic reconstructive surgery with ERAS protocol Incomplete bladder emptying after same day VT in PACU (as defined by an ultrasound or straight catheter post void residual of greater than 50% the total instilled volume within 10 minutes following a void postoperatively) Able to complete a telephone appointment on either postoperative day 1 or 3

Exclusion Criteria:

* Active urinary tract infection, defined by CDC criteria Patients undergoing pelvic reconstructive surgery where ERAS protocol is not utilized (examples: isolated Labiaplasty, chemodenervation with onabotulinum toxin A, urethral bulking, mid-urethral sling, sacral neuromodulation) Contraindication to ERAS protocol and/or its medications Elevated pre-op PVR greater than 200mL (on urodynamic testing or uroflow or straight catheter sample, that remains elevated after prolapse is reduced) Limited manual dexterity (limiting self-removal of catheter) Intra-op cystotomy or urinary tract injury Planned long term catheterization (e.g., fistula repair, urethral diverticulum) Planned hospital admission or patients who are not discharged from hospital the same day of their surgery Pregnancy Dependent on catheterization to void preoperatively Patients who request clean intermittent catheterization (CIC) after immediate failed VT Neurological conditions that affect voiding function (examples: spinal cord lesions, multiple sclerosis, Parkinson's disease, past stroke history with residual neurologic deficits) Concomitant surgical procedure by another service Conversion to open surgery Patients discharged to nursing home or rehabilitation care facility

Primary outcomes:
measure: Percentage of patients requiring re-insertion of a transurethral urinary catheter
timeFrame: 7 days
Secondary outcomes:
measure: Short Term Catheter Burden Questionnaire
timeFrame: 7 days
measure: Urinary Force of stream
timeFrame: 7 days
measure: Urinary tract infection rate
timeFrame: 30 days
measure: Number of patient phone calls
timeFrame: 7 days
measure: Number of visits
timeFrame: 30 days
measure: Readmission rates
timeFrame: 30 days
measure: Prolonged catheterization
timeFrame: 30 days
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Megan Tarr
role: PRINCIPAL_INVESTIGATOR
References: