Indwelling vs Immediate Removal of Foley Catheter After Robotic Assisted Laparoscopic Sacrocolpopexy: a Prospective Study
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2015
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 5, 2016
CompletedFirst Posted
Study publicly available on registry
May 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2017
CompletedOctober 25, 2017
October 1, 2017
1.8 years
May 5, 2016
October 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 hours after discharge from PACU
Secondary Outcomes (2)
Urinary Tract Infections
30 day post op
Post-operative complications
30 days post op
Study Arms (2)
Foley
NO INTERVENTIONPatients will have Foley in place overnight after completion of surgery, which is currently standard of care at our institution.
No Foley
ACTIVE COMPARATORPatients will have Foley catheter removed 6 hours post-op.
Interventions
Eligibility Criteria
You may qualify if:
- Age 19-75
- Pelvic organ prolapse requiring robotic assisted, laparoscopic sacrocolpopexy.
You may not qualify if:
- Intraoperative complications necessitating a post-operative Foley
- Cystotomy
- EBL \>500mL
- Bowl injury
- Pre-operative urinary retention requiring an indwelling catheter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atlantic Health
Morristown, New Jersey, 07960, United States
Related Publications (9)
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.
PMID: 19037026BACKGROUNDSiddiqui 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.
PMID: 22397900BACKGROUNDAlessandri 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.
PMID: 16752265BACKGROUNDAhmed 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.
PMID: 24670774BACKGROUNDZhang 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.
PMID: 25398392BACKGROUNDSummitt 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.
PMID: 8203443BACKGROUNDDobbs 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.
PMID: 9352691BACKGROUNDDunn 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.
PMID: 14520213BACKGROUNDEllahi 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.
PMID: 34184246DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2016
First Posted
May 9, 2016
Study Start
December 1, 2015
Primary Completion
September 21, 2017
Study Completion
September 21, 2017
Last Updated
October 25, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share