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

NCT05820139 | Completed

• 1 other identifier: IRB00091698
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Voiding Dysfunction

Keywords

Urinary Tract Infections; overactive bladder; pelvic organ prolapse surgery; urinary incontinence surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• proportion of patients develops postoperative UTIs

  Day 7

• proportion of patients developing overactive bladder symptoms

  Week 6

• proportion of patients developing bladder pain or pressure

  Week 6

• proportion of patients requiring repeat outpatient voiding trials

  Week 6

• average number of days postoperatively, that require catheterization

  Week 6

Study Arms (2)

control group (voids 2/3 of the volume backfilled)

OTHER

control group

Procedure: Control Group

test group (voids ½ of the total volume backfilled)

ACTIVE COMPARATOR

test group)

Procedure: Test Group

Interventions

Control Group PROCEDURE

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

Also known as: backfill-assisted voiding trial

control group (voids 2/3 of the volume backfilled)

Test Group PROCEDURE

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

Also known as: backfill-assisted voiding trial

test group (voids ½ of the total volume backfilled)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pelvic organ prolapse or urinary incontinence
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonpregnant women \>18yo undergoing pelvic organ prolapse or urinary incontinence surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Urinary Bladder, Overactive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• David Lovejoy, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The voiding trial instructions for each specific patient will be given to the Post Anesthesia Care Unit (P(ACU) or floor Registered Nurse (RN) taking care of the patient and will include what volume voided equals a passing voiding trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be recruited at an Urogynecology office either at the pre-operative visit or on the day of surgery

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 19, 2023
• Study Start: July 11, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)