search
Back to results

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

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Foley
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Retention

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Atlantic Health

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Foley

No Foley

Arm Description

Patients will have Foley in place overnight after completion of surgery, which is currently standard of care at our institution.

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

Outcomes

Primary Outcome Measures

Urinary retention
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

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

Full Information

First Posted
May 5, 2016
Last Updated
October 24, 2017
Sponsor
Atlantic Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT02765893
Brief Title
Indwelling vs Immediate Removal of Foley Catheter After Robotic Assisted Laparoscopic Sacrocolpopexy: a Prospective Study
Official Title
Indwelling vs Immediate Removal of Foley Catheter After Robotic Assisted Laparoscopic Sacrocolpopexy: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 21, 2017 (Actual)
Study Completion Date
September 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlantic Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Foley
Arm Type
No Intervention
Arm Description
Patients will have Foley in place overnight after completion of surgery, which is currently standard of care at our institution.
Arm Title
No Foley
Arm Type
Active Comparator
Arm Description
Patients will have Foley catheter removed 6 hours post-op.
Intervention Type
Other
Intervention Name(s)
No Foley
Intervention Description
Patients will have Foley catheter removed 6 hours post-op.
Primary Outcome Measure Information:
Title
Urinary retention
Description
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
Time Frame
6 hours after discharge from PACU
Secondary Outcome Measure Information:
Title
Urinary Tract Infections
Description
All UTIs will be documented up to 30days post op.
Time Frame
30 day post op
Title
Post-operative complications
Description
Post-operative complications
Time Frame
30 days post op

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Atlantic Health
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19037026
Citation
Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.
Results Reference
background
PubMed Identifier
22397900
Citation
Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012 May;206(5):435.e1-5. doi: 10.1016/j.ajog.2012.01.035. Epub 2012 Feb 1.
Results Reference
background
PubMed Identifier
16752265
Citation
Alessandri F, Mistrangelo E, Lijoi D, Ferrero S, Ragni N. A prospective, randomized trial comparing immediate versus delayed catheter removal following hysterectomy. Acta Obstet Gynecol Scand. 2006;85(6):716-20. doi: 10.1080/00016340600606976.
Results Reference
background
PubMed Identifier
24670774
Citation
Ahmed MR, Sayed Ahmed WA, Atwa KA, Metwally L. Timing of urinary catheter removal after uncomplicated total abdominal hysterectomy: a prospective randomized trial. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:60-3. doi: 10.1016/j.ejogrb.2014.02.038. Epub 2014 Mar 4.
Results Reference
background
PubMed Identifier
25398392
Citation
Zhang P, Hu WL, Cheng B, Cheng L, Xiong XK, Zeng YJ. A systematic review and meta-analysis comparing immediate and delayed catheter removal following uncomplicated hysterectomy. Int Urogynecol J. 2015 May;26(5):665-74. doi: 10.1007/s00192-014-2561-0. Epub 2014 Nov 15.
Results Reference
background
PubMed Identifier
8203443
Citation
Summitt RL Jr, Stovall TG, Bran DF. Prospective comparison of indwelling bladder catheter drainage versus no catheter after vaginal hysterectomy. Am J Obstet Gynecol. 1994 Jun;170(6):1815-8; discussion 1818-21. doi: 10.1016/s0002-9378(94)70358-2.
Results Reference
background
PubMed Identifier
9352691
Citation
Dobbs SP, Jackson SR, Wilson AM, Maplethorpe RP, Hammond RH. A prospective, randomized trial comparing continuous bladder drainage with catheterization at abdominal hysterectomy. Br J Urol. 1997 Oct;80(4):554-6. doi: 10.1046/j.1464-410x.1997.t01-1-00376.x.
Results Reference
background
PubMed Identifier
14520213
Citation
Dunn TS, Shlay J, Forshner D. Are in-dwelling catheters necessary for 24 hours after hysterectomy? Am J Obstet Gynecol. 2003 Aug;189(2):435-7. doi: 10.1067/s0002-9378(03)00496-4.
Results Reference
background
PubMed Identifier
34184246
Citation
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs