Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial

NCT03141372 | Completed Results FDA Device

• 1 other identifier: FLA 17-020
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Acute urinary retention is a complication of hysterectomies that can result in bladder over-distension and long term bladder dysfunction. The incidence of acute urinary retention after total laparoscopic hysterectomy (TLH) has been reported to be anywhere between 4% and 34%. Studies have varied in the method of post-operative bladder challenge and the modality of hysterectomy included. Moreover, most of the published studies are retrospective chart reviews or prospective observational studies, with a lack of randomized controlled trials. Risk factors for urinary retention include type of anesthesia used, how the hysterectomy is performed, use of post-operative narcotics, pre-operative urinary retention, and possibly aggressive bladder dissection. With the increased trend towards same-day discharge following TLH, urinary retention may cause unnecessary patient distress and a worsened post-operative course. Standardization of post-hysterectomy bladder challenge and identification of risk factors for urinary retention may aid in preventing urinary retention or acute bladder dysfunction. The primary objective is to compare the rate of void trial failure after TLH with the backfill technique versus the autofill technique.

Conditions

Urinary Retention; Voiding Disorders

Keywords

Total Laparoscopic Hysterectomy; Urinary Retention; Backfill Void Trial; Autofill Void Trial

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Void Trial Failure Rate

  The primary endpoint of this study will be to determine if the rate of void trial failure after total laparoscopic hysterectomy is different after the autofill method versus the backfill method.

  post-operative day, about 4 hours post-surgery

Secondary Outcomes (6)

• Time to Discharge

  post-operative day, about 4 hours post-surgery

• Number of Patients With Urinary Retention

  10-14 days post-surgery

• Number of Participants With Post-Operative Urinary Tract Infection

  up to 14 days post-surgery

• Quality of Bladder Function Using the Incontinence Impact Questionnaire

  pre-surgery and 14 days post-surgery

• Patient Perception of Bladder Condition Score

  presurgery and at 10-14 days post-surgery

Study Arms (2)

Autofill Void Trial

ACTIVE COMPARATOR

Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR \> 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.

Device: Void Trial using Foley catheter

Backfill Void Trial

ACTIVE COMPARATOR

About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR \> 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.

Device: Void Trial using Foley catheter

Interventions

Void Trial using Foley catheter DEVICE

A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.

Also known as: Bladder challenge

Autofill Void Trial; Backfill Void Trial

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females at least 18 years of age
• Understand and voluntarily sign an informed consent form
• English-speaking (able to read and understand English)
• Undergoing total laparoscopic hysterectomy for benign indication

You may not qualify if:

• Undergoing concomitant procedures in addition to hysterectomy which may cause urinary dysfunction
• Undergoing robotic-assisted laparoscopy or laparotomy
• Known history of pre-operative urinary incontinence or retention
• History of prior bladder or prolapse surgery
• Neurologic or spinal cord injury affecting bladder function
• Pregnant women
• Evidence of gynecologic malignancy
• Currently taking anticholinergic medications

Sponsors & Collaborators

• Sara Farag: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (22)

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• Farag S, Padilla PF, Smith KA, Zimberg SE, Sprague ML. Postoperative Urinary Retention Rates after Autofill versus Backfill Void Trial following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Apr;28(4):829-837. doi: 10.1016/j.jmig.2020.07.013. Epub 2020 Jul 24.

  PMID: 32712322 DERIVED

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Sara Farag, Fellow in Minimally Invasive Gynecologic Surgery
• Organization: Cleveland Clinic Florida

faragsara@gmail.com

8147691904

Study Officials

• Michael L Sprague, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Fellow in Minimally Invasive Gynecologic Surgery

Model Details: Subjects will be randomized to a backfill void trial following total laparoscopic hysterectomy or an autofill void trial following total laparoscopic hysterectomy

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: May 16, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: October 11, 2018
• Results First Posted: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)