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

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765893
• Other study ID #: 791664-1
• Status: Completed
• Phase: N/A
• First received: May 5, 2016
• Last updated: October 24, 2017
• Start date: December 2015
• Est. completion date: September 21, 2017

Study information

• Verified date: October 2017
• Source: Atlantic Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 21, 2017
• Est. primary completion date: September 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Other:
• No Foley
Patients will have Foley catheter removed 6 hours post-op.

Locations

Country	Name	City	State
United States	Atlantic Health	Morristown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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):1201-6. doi: 10.1097/AOG.0b013e31818ce394. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Urinary Tract Infections	All UTIs will be documented up to 30days post op.	30 day post op
Secondary	Post-operative complications	Post-operative complications	30 days post op