Self-discontinuation of a Transurethral Catheter

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Urinary Retention
• Intervention / Treatment: Procedure: Self-removal

Detailed 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 Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-removal group; The patients randomized to the self-removal group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.	Procedure: Self-removal; Self-discontinuation of a transurethral catheter
No Intervention: Office-removal group; The patients randomized to the office-removal group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Postoperative Urinary Retention	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	postoperative day 6-8

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Publications and helpful links

General Publications

• Shatkin-Margolis A, Yook E, Hill AM, Crisp CC, Yeung J, Kleeman S, Pauls RN. Self-Removal of a Urinary Catheter After Urogynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Nov;134(5):1027-1036. doi: 10.1097/AOG.0000000000003531.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Actual): May 16, 2019
• Study Completion (Actual): May 16, 2019

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: 16-075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO