Clinical trial NCT02765893: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 88
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Urinary retention
timeFrame: 6 hours after discharge from PACU
Secondary outcomes:
measure: Urinary Tract Infections
timeFrame: 30 day post op
measure: Post-operative complications
timeFrame: 30 days post op
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health
state: New Jersey
Study officials:
References:
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.
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.
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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.
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.
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.
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.