Catheter Management After Pelvic Reconstructive Surgery

Catheter Management After Pelvic Reconstructive Surgery: a Randomized Controlled Trial

This is a randomized controlled trial comparing plug-unplug catheter management, continuous drainage catheter systems and patients that do not get discharged with catheters after inpatient pelvic reconstructive surgery.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Urinary Retention Postoperative
• Intervention / Treatment: Device: Plug-unplug catheter management; Device: Continuous drainage catheter management

Detailed Description

This study will be a randomized controlled trial comparing plug-unplug (PUP) catheter management, continuous drainage (CD) catheter systems and patients that do not get discharged with catheters (reference) after pelvic reconstructive surgery. The primary objective of this study is to assess impact on activity. The secondary objectives are to compare the rate of urinary tract infection between the groups, duration of time (days) it takes for patients to resume normal voiding, impact on post-operative pain and satisfaction with surgery experience and post-operative recovery. The investigators hypothesize that patient activity/mobility one week after surgery between the two methods of managing the transurethral catheter will be different between arms. Subjects will be recruited at the Hartford Hospital Division of Female Pelvic Medicine and Reconstructive Surgery during preoperative consultation for pelvic reconstructive surgery with 1:1:1 assignment and randomization for PUP and CD groups only. Prior to surgery, baseline activity will be assessed using the Activity Assessment Scale, as well as postoperative expectations. Prior to hospital discharge, patients will undergo a postoperative voiding trial (PVT) per regular clinical practice. Upon failure of PVT, participants will be randomized 1:1 to one of two arms in which participants receive a catheter: PUP or CD. The investigator responsible for data collection will remain blinded to the treatment assignment throughout the study. Subjects who pass the PVT test and therefore do not require a catheter will be assigned to the reference arm (Arm C). Subjects will be followed after hospital discharge and assessed using the same pre- and post-operative questionnaires as participants randomized to the CD and PUP arms and will comprise the first 32 consenting patients who do not require a catheter.

Subjects randomized to CD will have a 16F transurethral catheter attached to a leg bag and receive teaching regarding home maintenance. Subjects randomized to PUP will have the same 16F transurethral catheter placed with a plastic plug and instructed to unplug and drain the catheter when they feel the urge to void, or at least every four hours throughout the day. Subjects in both groups will be provided a large bag for gravity-based drainage during the night. Subjects also will be encouraged to call the research team with any catheter-related questions or concerns including symptoms of urinary tract infection (UTI). Subjects with symptoms of UTI (e.g., dysuria, urgency, frequency, and/or hematuria) will be evaluated and treated per standard of care. All participants will then return for an office voiding trial (OVT) five to seven days after hospital discharge, following the same protocol as the PVT. At this time urinalysis will be obtained. Only those participants who endorse symptoms of UTI will have a urine specimen collected and sent for culture. This is in line with the current clinical practice by the investigators. Participants will be treated for UTI based on culture results or if there is high clinical suspicion at the time of office follow-up. Participants who fail the OVT will be discharged home with bladder drainage per standard of care and undergo routine follow-up until they pass a repeat voiding trial.

The subjects will complete a post-operative questionnaire assessing pain, impact on activity and satisfaction. Outcomes will be followed for up to six weeks after initial OVT if it is failed; however, no additional research-associated visits will be necessary from study participants beyond the initial office visit.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Age 18-89
• Inpatient surgery
• surgery for pelvic organ prolapse with or without mid-urethral slings who fail initial voiding trial at the time of hospital discharge
• willing/able to provide written informed consent

Exclusion Criteria:

• male
• age < 18 or >89
• unwilling or unable to provide written informed consent
• undergoing outpatient surgery.
• planned postoperative catheter use
• discharged to a nursing facility or who are not candidates for the plug-unplug method for another reason (e.g., poor hand dexterity, paraplegia)
• suprapubic catheter placement
• procedures involving urethral bulking or Onabotulinum toxin A (Botox) injection
• procedures involving planned urethral or bladder surgery (e.g., fistula excision, mesh excision, excision of urethral diverticulum)
• procedures with only posterior vaginal repair
• presence of a neurologic condition affecting urinary function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Plug-unplug Group; Participants randomized to plug-unplug catheter management. Participants plug and unplug catheters when they feel urge to void or at least every 4 hours during the day. Participants are given the option to use a large drainage bag for convenience overnight.	Device: Plug-unplug catheter management; Transurethral catheter is plugged with a plastic cap and participants are taught to unplug during the day when they feel the urge to void or at least every 4 hours.
ACTIVE_COMPARATOR: Continuous Drainage Group; Participants randomized to continuous drainage catheter management. Catheters are attached to a leg bag during the day and large drainage bag for convenience overnight.	Device: Continuous drainage catheter management; Transurethral catheter is attached to a continuous drainage bag.
NO_INTERVENTION: Reference Group; Participants that do not fail inpatient voiding trial and go home without a catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity Assessment Scale	Participants complete this 18-question survey preoperatively and 3-5 days postoperatively.	Postoperative day 3-5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative expectations	Patients complete a preoperative expectations survey prior to surgery.	At the time of consent
Days until passing voiding trial	Evaluate rates of passing voiding trial between arms	up to 6 weeks postoperatively
Urinary Tract infection	Rates of urinary tract infection between arms	up to 6 weeks postoperatively

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Investigators: Principal Investigator: Sarah S Boyd, MD, Hartford Hospital; Principal Investigator: Elena Tunitsky-Bitton, MD, Hartford Hospital

Publications and helpful links

General Publications

• Boyd SS, O'Sullivan DM, Tunitsky-Bitton E. A Comparison of Two Methods of Catheter Management After Pelvic Reconstructive Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Nov;134(5):1037-1045. doi: 10.1097/AOG.0000000000003525.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2017
• Primary Completion (ACTUAL): December 7, 2018
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (ACTUAL): March 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: pelvic organ prolapse; urinary catheters
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Urinary Retention
• Other Study ID Numbers: HHC-2016-0228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this time, it is undecided if IPD will be made available to other researchers at the end of this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No