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

NCT03141372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2018-10-11

Study results available
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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

Interventions

DEVICE

Void Trial using Foley catheter

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.

Sponsors & Collaborators

  • Sara Farag

    lead OTHER

Principal Investigators

  • Michael L Sprague, MD · Cleveland Clinic Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-16
Primary Completion
2018-04-30
Completion
2018-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141372 on ClinicalTrials.gov