NCT03071211

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

February 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

February 24, 2017

Last Update Submit

January 31, 2019

Conditions

Urinary Retention PostoperativePelvic Organ Prolapse

Keywords

pelvic organ prolapseurinary catheters

Outcome Measures

Primary Outcomes (1)

  • Activity Assessment Scale

    Participants complete this 18-question survey preoperatively and 3-5 days postoperatively.

    Postoperative day 3-5

Secondary Outcomes (3)

  • Preoperative expectations

    At the time of consent

  • Days until passing voiding trial

    up to 6 weeks postoperatively

  • Urinary Tract infection

    up to 6 weeks postoperatively

Study Arms (3)

Plug-unplug Group

EXPERIMENTAL

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

Continuous Drainage Group

ACTIVE COMPARATOR

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

Reference Group

NO INTERVENTION

Participants that do not fail inpatient voiding trial and go home without a catheter.

Interventions

Plug-unplug catheter managementDEVICE

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.

Plug-unplug Group
Continuous drainage catheter managementDEVICE

Transurethral catheter is attached to a continuous drainage bag.

Continuous Drainage Group

Eligibility Criteria

Age18 Years - 89 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

  • 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.

    PMID: 31599826DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah S Boyd, MD

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

  • Elena Tunitsky-Bitton, MD

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow physician

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 6, 2017

Study Start

February 26, 2017

Primary Completion

December 7, 2018

Study Completion

January 31, 2019

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

US(1)