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

A Randomized Controlled Single-Blinded Study Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

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

Study Overview

• Status: Completed
• Conditions: Voiding Dysfunction
• Intervention / Treatment: Procedure: Control Group; Procedure: Test Group

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group (voids 2/3 of the volume backfilled); control group	Procedure: Control Group; Patients will be randomized to a 200mL (control group); Other Names: backfill-assisted voiding trial
Active Comparator: test group (voids ½ of the total volume backfilled); test group)	Procedure: Test Group; Patients will be randomized to a cut-off of 150mL (test group); Other Names: backfill-assisted voiding trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients develops postoperative UTIs	UTI diagnosed by symptomatology alone or urinalysis (UA) + culture proven within one week (7 days) of catheter removal	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)	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)	Week 6
proportion of patients requiring repeat outpatient voiding trials	proportion of patients requiring repeat outpatient voiding trials	Week 6
average number of days postoperatively, that require catheterization	average number of days postoperatively, that require catheterization	Week 6

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: David Lovejoy, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: overactive bladder; Urinary Tract Infections; pelvic organ prolapse surgery; urinary incontinence surgery
• Other Study ID Numbers: IRB00091698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No