A Comparison of Two Methods of Catheter Management After Pelvic Reconstructive Surgery: A Randomized Controlled Trial

Sarah S. Boyd, David M. OʼSullivan, Elena Tunitsky-Bitton

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: To compare effects on activity between two catheter management systems after failed voiding trial after pelvic reconstructive surgery. METHODS: Women with a failed postoperative voiding trial after reconstructive pelvic surgeries were randomized to plug-unplug or continuous drainage catheters. The primary outcome was a mean activity assessment scale score. Secondary outcomes included urinary tract infection (UTI), time to passing outpatient voiding trial, and patient satisfaction. Enrollees who passed the voiding trial were assigned to a "Reference" arm. Ninety participants (30 per arm) provided more than 80% power to detect an effect size of 0.33 in the primary outcome, using a two-sided alpha of 0.05. RESULTS: Sixty-three patients were randomized (32 plug-unplug, 31 continuous drainage). The first 30 participants discharged without a catheter comprised the reference arm. There was no difference in postoperative activity assessment scale scores (total: plug-unplug 70.3, continuous drainage 67.7, reference arm 79.4; P=.090) between arms. Women in the continuous drainage arm noted more difficulty compared with the plug-unplug arm when managing the catheter "during the day" (P=.043) and "all the time" (P=.049) and felt the catheter impeded activities (P=.012) and wearing clothes (P=.005). The catheter arms had significantly higher rates of culture-positive UTI compared with the reference arm (58.7% vs 6.7%, P<.001). However, rate of UTI did not differ between catheter arms (plug-unplug, 68.8% vs continuous drainage, 48.4%, P=.625). The majority of patients passed their outpatient voiding trials at the initial postoperative visit (plug-unplug 71.9%, continuous drainage 58.1%, P=.250). There was no difference in patient satisfaction, with the majority reporting they were "very satisfied" (plug-unplug 78.1%, continuous drainage 80.0%, reference 66.7%, P=.202). CONCLUSION: Postoperative activity does not differ in patients discharged with plug-unplug or continuous drainage catheters, but those with plug-unplug perceive easier management and ability to complete activities of daily living. The plug-unplug method is an acceptable alternative to traditional catheterization after pelvic reconstructive surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03071211.

Original languageEnglish (US)
Pages (from-to)1037-1045
Number of pages9
JournalObstetrics and gynecology
Volume134
Issue number5
DOIs
StatePublished - Nov 1 2019

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Reconstructive Surgical Procedures
Drainage
Catheters
Randomized Controlled Trials
Urinary Tract Infections
Patient Satisfaction
Outpatients
Clothing
Activities of Daily Living
Catheterization
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Cite this

@article{0e48366811734f0ebbc884f373454ffc,
title = "A Comparison of Two Methods of Catheter Management After Pelvic Reconstructive Surgery: A Randomized Controlled Trial",
abstract = "OBJECTIVE: To compare effects on activity between two catheter management systems after failed voiding trial after pelvic reconstructive surgery. METHODS: Women with a failed postoperative voiding trial after reconstructive pelvic surgeries were randomized to plug-unplug or continuous drainage catheters. The primary outcome was a mean activity assessment scale score. Secondary outcomes included urinary tract infection (UTI), time to passing outpatient voiding trial, and patient satisfaction. Enrollees who passed the voiding trial were assigned to a {"}Reference{"} arm. Ninety participants (30 per arm) provided more than 80{\%} power to detect an effect size of 0.33 in the primary outcome, using a two-sided alpha of 0.05. RESULTS: Sixty-three patients were randomized (32 plug-unplug, 31 continuous drainage). The first 30 participants discharged without a catheter comprised the reference arm. There was no difference in postoperative activity assessment scale scores (total: plug-unplug 70.3, continuous drainage 67.7, reference arm 79.4; P=.090) between arms. Women in the continuous drainage arm noted more difficulty compared with the plug-unplug arm when managing the catheter {"}during the day{"} (P=.043) and {"}all the time{"} (P=.049) and felt the catheter impeded activities (P=.012) and wearing clothes (P=.005). The catheter arms had significantly higher rates of culture-positive UTI compared with the reference arm (58.7{\%} vs 6.7{\%}, P<.001). However, rate of UTI did not differ between catheter arms (plug-unplug, 68.8{\%} vs continuous drainage, 48.4{\%}, P=.625). The majority of patients passed their outpatient voiding trials at the initial postoperative visit (plug-unplug 71.9{\%}, continuous drainage 58.1{\%}, P=.250). There was no difference in patient satisfaction, with the majority reporting they were {"}very satisfied{"} (plug-unplug 78.1{\%}, continuous drainage 80.0{\%}, reference 66.7{\%}, P=.202). CONCLUSION: Postoperative activity does not differ in patients discharged with plug-unplug or continuous drainage catheters, but those with plug-unplug perceive easier management and ability to complete activities of daily living. The plug-unplug method is an acceptable alternative to traditional catheterization after pelvic reconstructive surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03071211.",
author = "Boyd, {Sarah S.} and OʼSullivan, {David M.} and Elena Tunitsky-Bitton",
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A Comparison of Two Methods of Catheter Management After Pelvic Reconstructive Surgery : A Randomized Controlled Trial. / Boyd, Sarah S.; OʼSullivan, David M.; Tunitsky-Bitton, Elena.

In: Obstetrics and gynecology, Vol. 134, No. 5, 01.11.2019, p. 1037-1045.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A Comparison of Two Methods of Catheter Management After Pelvic Reconstructive Surgery

T2 - A Randomized Controlled Trial

AU - Boyd, Sarah S.

AU - OʼSullivan, David M.

AU - Tunitsky-Bitton, Elena

PY - 2019/11/1

Y1 - 2019/11/1

N2 - OBJECTIVE: To compare effects on activity between two catheter management systems after failed voiding trial after pelvic reconstructive surgery. METHODS: Women with a failed postoperative voiding trial after reconstructive pelvic surgeries were randomized to plug-unplug or continuous drainage catheters. The primary outcome was a mean activity assessment scale score. Secondary outcomes included urinary tract infection (UTI), time to passing outpatient voiding trial, and patient satisfaction. Enrollees who passed the voiding trial were assigned to a "Reference" arm. Ninety participants (30 per arm) provided more than 80% power to detect an effect size of 0.33 in the primary outcome, using a two-sided alpha of 0.05. RESULTS: Sixty-three patients were randomized (32 plug-unplug, 31 continuous drainage). The first 30 participants discharged without a catheter comprised the reference arm. There was no difference in postoperative activity assessment scale scores (total: plug-unplug 70.3, continuous drainage 67.7, reference arm 79.4; P=.090) between arms. Women in the continuous drainage arm noted more difficulty compared with the plug-unplug arm when managing the catheter "during the day" (P=.043) and "all the time" (P=.049) and felt the catheter impeded activities (P=.012) and wearing clothes (P=.005). The catheter arms had significantly higher rates of culture-positive UTI compared with the reference arm (58.7% vs 6.7%, P<.001). However, rate of UTI did not differ between catheter arms (plug-unplug, 68.8% vs continuous drainage, 48.4%, P=.625). The majority of patients passed their outpatient voiding trials at the initial postoperative visit (plug-unplug 71.9%, continuous drainage 58.1%, P=.250). There was no difference in patient satisfaction, with the majority reporting they were "very satisfied" (plug-unplug 78.1%, continuous drainage 80.0%, reference 66.7%, P=.202). CONCLUSION: Postoperative activity does not differ in patients discharged with plug-unplug or continuous drainage catheters, but those with plug-unplug perceive easier management and ability to complete activities of daily living. The plug-unplug method is an acceptable alternative to traditional catheterization after pelvic reconstructive surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03071211.

AB - OBJECTIVE: To compare effects on activity between two catheter management systems after failed voiding trial after pelvic reconstructive surgery. METHODS: Women with a failed postoperative voiding trial after reconstructive pelvic surgeries were randomized to plug-unplug or continuous drainage catheters. The primary outcome was a mean activity assessment scale score. Secondary outcomes included urinary tract infection (UTI), time to passing outpatient voiding trial, and patient satisfaction. Enrollees who passed the voiding trial were assigned to a "Reference" arm. Ninety participants (30 per arm) provided more than 80% power to detect an effect size of 0.33 in the primary outcome, using a two-sided alpha of 0.05. RESULTS: Sixty-three patients were randomized (32 plug-unplug, 31 continuous drainage). The first 30 participants discharged without a catheter comprised the reference arm. There was no difference in postoperative activity assessment scale scores (total: plug-unplug 70.3, continuous drainage 67.7, reference arm 79.4; P=.090) between arms. Women in the continuous drainage arm noted more difficulty compared with the plug-unplug arm when managing the catheter "during the day" (P=.043) and "all the time" (P=.049) and felt the catheter impeded activities (P=.012) and wearing clothes (P=.005). The catheter arms had significantly higher rates of culture-positive UTI compared with the reference arm (58.7% vs 6.7%, P<.001). However, rate of UTI did not differ between catheter arms (plug-unplug, 68.8% vs continuous drainage, 48.4%, P=.625). The majority of patients passed their outpatient voiding trials at the initial postoperative visit (plug-unplug 71.9%, continuous drainage 58.1%, P=.250). There was no difference in patient satisfaction, with the majority reporting they were "very satisfied" (plug-unplug 78.1%, continuous drainage 80.0%, reference 66.7%, P=.202). CONCLUSION: Postoperative activity does not differ in patients discharged with plug-unplug or continuous drainage catheters, but those with plug-unplug perceive easier management and ability to complete activities of daily living. The plug-unplug method is an acceptable alternative to traditional catheterization after pelvic reconstructive surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03071211.

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