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CompletedNCT02765893Updated Oct 25, 2017

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

An interventional study of No Foley in Urinary Retention, sponsored by Atlantic Health System. Completed at 1 site in United States. Open to female participants aged 19 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by Atlantic Health System · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
Female
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Study 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.

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Conditions studied

  • Urinary Retention

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03

In context

Urinary Retention

235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.

This study's enrollment of 88 is close to the median of 95 across 185 interventional studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

Atlantic Health System is the lead sponsor of 61 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 19-75
  • Pelvic organ prolapse requiring robotic assisted, laparoscopic sacrocolpopexy.

Exclusion criteria

Exclusion Criteria:

  • Intraoperative complications necessitating a post-operative Foley

    • Cystotomy
    • EBL >500mL
    • Bowl injury
  • Pre-operative urinary retention requiring an indwelling catheter
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • No intervention
    Foley

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

  • Active comparator
    No Foley

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

    Other: No Foley

Interventions

  • OtherNo Foley

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

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What researchers measure

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

    Time frame: 6 hours after discharge from PACU

Secondary outcomes

  1. Urinary Tract Infections

    All UTIs will be documented up to 30days post op.

    Time frame: 30 day post op

  2. Post-operative complications

    Post-operative complications

    Time frame: 30 days post op

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Study locations

1 site
  • Atlantic Health
    Morristown, New Jersey 07960, United States
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References and documents

Publications

  • 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. PubMed 19037026 ↗
  • 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. PubMed 22397900 ↗
  • 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. PubMed 16752265 ↗
  • 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. PubMed 24670774 ↗
  • 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. PubMed 25398392 ↗
  • 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. PubMed 8203443 ↗
  • 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. PubMed 9352691 ↗
  • 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. PubMed 14520213 ↗
  • 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. PubMed 34184246 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02765893
Lead sponsor
Atlantic Health System
Responsible party
Sponsor
First posted
May 9, 2016
Start date
Dec 2015
Primary completion
Sep 21, 2017
Completion
Sep 21, 2017
Last update
Oct 25, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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