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OpenTrials
Completed

NCT Number: NCT02996968

Self-discontinuation of a Transurethral Catheter

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing vaginal vault suspension or robot-assisted laparoscopic sacrocolpopexy by a physician at Cincinnati Urogynecology Associates, TriHealth Inc.for the treatment of pelvic organ prolapse
  • Failed voiding trial prior to discharge
  • Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy

Exclusion criteria

  • physical or mental impairment that would affect the subject's ability to self-remove indwelling urinary catheter, including patient's with Multiple Sclerosis, Dementia, Parkinsonism, or those who have impaired mobility or are wheelchair bound
  • Bladder injury, fistula repair or other need for prolonged catheterization

Treatment and study plan

Self-removal

Procedure

Self-discontinuation of a transurethral catheter

Primary outcomes

  1. Number of Participants With Postoperative Urinary Retention

    Time frame: postoperative day 6-8

    Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse.

    Pour at 1-week was defined as continued catheterization on POD 6-8

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Is Self-discontinuation of a Transurethral Catheter Following Pelvic Reconstructive Surgery as Effective as Office-based Discontinuation?; A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2016
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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