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

Not Applicable

Completed

• Conditions: Urinary Retention
• Interventions: Other: No Foley

• Registration Number: NCT02765893
• Lead Sponsor: Atlantic Health System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-09
• Primary Completion: 2017-09-21
• Study Completion: 2017-09-21
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Foley	No Foley	Patients will have Foley catheter removed 6 hours post-op.

Primary Outcome Measures

Name	Time	Method
Urinary retention	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

Secondary Outcome Measures

Name	Time	Method
Urinary Tract Infections	30 day post op	All UTIs will be documented up to 30days post op.
Post-operative complications	30 days post op	Post-operative complications

Trial Locations

Locations (1)

Atlantic Health; 🇺🇸 Morristown, New Jersey, United States