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

Not Applicable

Completed

• Conditions: Voiding Dysfunction
• Interventions: Procedure: Control Group; Procedure: Test Group

• Registration Number: NCT05820139
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-19
• Study Start: 2023-07-11
• Primary Completion: 2024-02-26
• Study Completion: 2024-02-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group (voids 2/3 of the volume backfilled)	Control Group	control group
test group (voids ½ of the total volume backfilled)	Test Group	test group)

Primary Outcome Measures

Name	Time	Method
difference in acute voiding dysfunction between a backfill assisted voiding trial	Week 6	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)

Secondary Outcome Measures

Name	Time	Method
proportion of patients develops postoperative UTIs	Day 7	UTI diagnosed by symptomatology alone or urinalysis (UA) + culture proven within one week (7 days) of catheter removal
proportion of patients requiring repeat outpatient voiding trials	Week 6	proportion of patients requiring repeat outpatient voiding trials
proportion of patients developing bladder pain or pressure	Week 6	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)
proportion of patients developing overactive bladder symptoms	Week 6	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)
average number of days postoperatively, that require catheterization	Week 6	average number of days postoperatively, that require catheterization

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States