Self-discontinuation of a Transurethral Catheter

Status Completed

Clinical Trial Summary

This study is to determine if self-discontinuation of transurethral foley catheters in patients diagnosed with postoperative urinary retention (POUR), which is defined as the continued need for catheterization, following impatient pelvic organ prolapse surgery is non-inferior to office-discontinuation.

Clinical Trial Description

Postoperative urinary retention (POUR) is a common issue following urogynecologic surgery, with incidence rates of 1.4-43%. The wide range of incidence is due to the lack of a standardized definition of POUR. Generally speaking, POUR can be characterized by any impairment in bladder emptying following surgery. While the gold standard for assessing voiding function remains measurement of a postvoid residual (PVR), there are many voiding trial (VT) methods being used across institutions.

Historically, the most widely accepted postoperative VT for the assessment of voiding function was the backfill method. An alternative assessment of voiding function is the spontaneous VT, where the indwelling catheter is removed and a patient is asked to void spontaneously when a patient has the urge. It is controversial which of these methods are superior, and studies are conflicted. Nevertheless, both of these methods were studied in a clinical setting, and we lack information on self-discontinuation efficacy at home.

Managing an indwelling urinary catheter and returning to the outpatient clinic only a week after discharge from the hospital can be overwhelming for patients and their involved caregivers. Given the low incidence of POUR at one-week postoperative and patient dissatisfaction with urinary catheter management, home self-removal of indwelling urinary catheters is an important topic of investigation.

We are trying to compare the incidence of POUR between self-discontinuation and office-discontinuation of urinary catheters. The results of this study could impact on the decision regarding catheter use following inpatient pelvic organ prolapse surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02996968
Study type	Interventional
Source	TriHealth Inc.
Contact
Status	Completed
Phase	N/A
Start date	January 10, 2017
Completion date	May 16, 2019

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See also
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Recruiting	`NCT05664633` - The Role of Sugammadex in Posotoperative Urinary Retention in Patients Undergoing Pelvic Floor Reconstructive Procedures	Phase 1/Phase 2
Terminated	`NCT02518971` - Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients	Phase 3
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Not yet recruiting	`NCT06258785` - Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.