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Completed Not applicable Interventional Results available

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

ClinicalTrials.gov ID: NCT03141372

Public ClinicalTrials.gov record NCT03141372. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Urinary Retention Rates After Immediate Removal of Foley Catheter Versus Backfill Void Trial Following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03141372
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Sara Farag
Other
Enrollment
84 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 15, 2017
Primary completion
Apr 29, 2018
Completion
Apr 29, 2018
Last update posted
Oct 10, 2018

2017 – 2018

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cleveland Clinic Florida Weston Florida 33331

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03141372, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 10, 2018 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03141372 live on ClinicalTrials.gov.

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