Clinical trial NCT06344884: Early Patient Removal of Urinary Catheters After Urogynecologic Surgery
Official title: Early Patient Removal of Urinary Catheters After Urogynecologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Retention Postoperative
Postoperative Urinary Tract Infection
Catheter Site Pain
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: SUPPORTIVE_CARE

Brief summary: Management of postoperative urinary retention often requires the use of indwelling catheters. In a previous study, the investigators determined that patient removal of catheters at home is non-inferior to standard office removal on postoperative day three or four (POD3-4). The purpose of this study is to determine whether patient removal of catheters at home on postoperative day one (POD1) is noninferior to removal on POD 3-4.

Detailed description: Randomized, controlled, non-inferiority trial to compare the risk of urinary retention between patient urinary catheter removal on POD1 versus POD3-4 after urogynecologic surgery.

Aim One: Is the risk of urinary retention non-inferior with patient removal of transurethral catheters on POD1 versus POD3-4 after urogynecologic surgery?

Aim Two: Does healthcare resource utilization (nursing calls, patient messages, and office visits) differ between patient removal of transurethral catheters on POD1 versus POD3-4?

Aim Three: Does the patient experience differ between patient removal of transurethral catheters on POD1 versus POD3-4?

Aim Four: Does the incidence of postoperative UTI differ between patient removal of transurethral catheters on POD1 versus POD3-4?

Aim Five: Does the risk of delayed or recurrent postoperative urinary retention differ between patient removal of transurethral catheters on POD1 versus POD3-4?

Screening: Preoperative clinics at UNC Rex Urogynecology will be screened for all women who are undergoing a prolapse or anti-incontinence procedure.

Study Treatment/Intervention

Postoperatively if patients fail their voiding trial in the post-anesthesia care unit (PACU) and are willing to perform home catheter removal after instruction

Patients will be randomized to a catheter management arm: self-catheter removal on POD1 or POD3-4

POD 1 - Patients in the intervention arm will be reminded to remove their catheters

They will be instructed to remove their urinary catheter at 0700 and to call the clinic office by noon if they have not voided

If they are unable to void or have any other concerning symptoms, they will be scheduled for a same day nurse visit

Patients who are unable to void will then be taught clean intermittent self-catheterization, per usual management of postoperative voiding dysfunction

POD 3 (or by POD 4 for Thursday cases) - Patients in the control arm will be reminded to remove their catheters

\* Patients undergoing surgery on Thursday will perform catheter removal on Monday. This is what was done in previous studies in order to prevent resource over-utilization on weekends. Patients undergoing surgery on Wednesday (typically only rare add-on cases) will be excluded.

They will be instructed to remove their urinary catheter at 0700 and to call the clinic office by noon if they have not voided

If they are unable to void or have any other concerning symptoms, they will be scheduled for a same day nurse visit

Patients who are unable to void will then be taught clean intermittent self-catheterization, per usual management of postoperative voiding dysfunction

Week 2 Phone Call

Patients will be called by study personnel to check in on any voiding symptoms or issues and complete phone survey regarding the following categories: Pain, Ease of use, Satisfaction, Likelihood to use again.

Week 6 Visit

Patients will have a standard office visit around 6 weeks postoperatively. At this visit, a post-void residual assessment will be performed.

Follow-up through postoperative visit after surgery

Postoperative complications, such as urinary tract infection (UTI) or delayed urinary retention will be monitored from the chart

Patients will be randomized on the day of surgery. Each subject's participation will last from the day of surgery to the day of catheter removal (on POD 1-4). They will also be called two weeks postoperatively for a check-in and survey over the phone. Postoperative complications will be monitored until their postoperative visit at 6-8 weeks after surgery.

The recruitment and data collection period is expected to last one year. The entire study including data collection, analysis and publication will take up to 3 years. -

Eligibility criteria: Inclusion Criteria:

* All women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge.

Exclusion Criteria:

* Non-English speaking (due to limited resources to consent non-English speaking patients)
* Pregnant
* Postvoid residual (PVR) \>150 mL or dependent upon catheterization to void pre-operatively
* Urethral bulking injection surgery
* Intra-operative complication requiring prolonged catheterization

Primary outcomes:
measure: Number of patients with ongoing urinary retention (noninferiority)
timeFrame: From Postoperative day 1 through postoperative week 8
Secondary outcomes:
measure: Number of patient contacts for voiding dysfunction by Type
timeFrame: From Postoperative day 1 through postoperative week 8
measure: Total patient contacts for voiding dysfunction Combined
timeFrame: From Postoperative day 1 through postoperative week 8
measure: Number of patients treated for postoperative UTI.
timeFrame: From Postoperative day 1 through postoperative week 8
measure: Number of patients with ongoing urinary retention
timeFrame: From Postoperative day 1 through postoperative week 8
measure: Patient Satisfaction Survey Score-Pain
timeFrame: Postoperative week 2
measure: Patient Satisfaction Survey Score-Ease of Use
timeFrame: Postoperative week 2
measure: Patient Satisfaction Survey Score-Satisfaction
timeFrame: Postoperative week 2
measure: Patient Satisfaction Survey Score-Likelihood to Use Again
timeFrame: Postoperative week 2
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: UNC Health Rex
state: North Carolina
Study officials:
affiliation: University of North Carollina at Chapel Hill
name: Lauren Tholemeier, MD
role: PRINCIPAL_INVESTIGATOR
References: