Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

N/ACompletedNCT05820139

Wake Forest University Health Sciences100 enrolled

Overview

Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events

Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Voiding Dysfunction

Interventions

Control GroupPROCEDURE

Patients will be randomized to a 200mL (control group)

Test GroupPROCEDURE

Patients will be randomized to a cut-off of 150mL (test group)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Nonpregnant women \>18yo undergoing pelvic organ prolapse or urinary incontinence surgery Exclusion Criteria: * Patients undergoing fistula repair or sacral neuromodulation * Voiding dysfunction preoperatively that requires intermittent self-catheterization * Intraoperative bladder injury * Pregnancy * Preoperative UTI (culture proven within 7 days prior to surgery)

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

difference in acute voiding dysfunction between a backfill assisted voiding trial

difference in acute voiding dysfunction between a backfill assisted voiding trial with a volume voided cutoff of 150mL vs. 200mL for passage of VT - Acute voiding dysfunction is defined as a failed voiding trial requiring discharge home with a catheter, as well as voiding dysfunction occurring at a later time that results in an emergency department/urgent care/clinic visit requiring either an indwelling catheter or clean intermittent catheterization (CIC)

Time frame: Week 6

Secondary Outcomes

proportion of patients develops postoperative UTIs

UTI diagnosed by symptomatology alone or urinalysis (UA) + culture proven within one week (7 days) of catheter removal

Time frame: Day 7

proportion of patients developing overactive bladder symptoms

Sudden urge to urinate that is difficult to hold, with leakage of urine (even if you just voided recently), Frequent urination (\>8 times/day), or waking up at night to urinate (2 or more times/night)

Time frame: Week 6

proportion of patients developing bladder pain or pressure

Bladder pain (pain or discomfort in the lower abdomen when your bladder is full) or bladder pressure (continuous feeling of pressure, not relieved by urination)

Time frame: Week 6

proportion of patients requiring repeat outpatient voiding trials

Time frame: Week 6

average number of days postoperatively, that require catheterization

Data from ClinicalTrials.gov

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