Indwelling vs Immediate Removal of Foley Catheter After Robotic Assisted Laparoscopic Sacrocolpopexy: a Prospective Study

October 24, 2017 updated by: Atlantic Health System

This is a prospective, comparative randomized study. Our study population includes women with pelvic organ prolapse undergoing a robotic assisted laparoscopic sacrocolpopexy.

The two groups will include the study group, who will have their Foley catheter removed 6 hours post-op, and the control group who will have an indwelling Foley catheter overnight. The two groups will be assigned according REDCap randomization system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 19-75
  • Pelvic organ prolapse requiring robotic assisted, laparoscopic sacrocolpopexy.

Exclusion Criteria:

  • Intraoperative complications necessitating a post-operative Foley

    • Cystotomy
    • EBL >500mL
    • Bowl injury
  • Pre-operative urinary retention requiring an indwelling catheter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Foley
Patients will have Foley in place overnight after completion of surgery, which is currently standard of care at our institution.
Active Comparator: No Foley
Patients will have Foley catheter removed 6 hours post-op.
Other: No Foley
Patients will have Foley catheter removed 6 hours post-op.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary retention
Time Frame: 6 hours after discharge from PACU
Patients in the intervention group will have their Foley catheter removed up to 6 hours after discharge from the PCA. They will then have to undergo a voiding trial
6 hours after discharge from PACU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Tract Infections
Time Frame: 30 day post op
All UTIs will be documented up to 30days post op.
30 day post op
Post-operative complications
Time Frame: 30 days post op
Post-operative complications
30 days post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

September 21, 2017

Study Completion (Actual)

September 21, 2017

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 791664-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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