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

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.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Age range

19 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atlantic Health

Morristown, New Jersey, 07960, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Foley

Other

Patients will have Foley catheter removed 6 hours post-op.

Primary outcomes

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

Secondary outcomes

Urinary Tract Infections

Time frame: 30 day post op

All UTIs will be documented up to 30days post op.
Post-operative complications

Time frame: 30 days post op

Post-operative complications

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: May 9, 2016
Registry last updated: Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed