The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial
November 19, 2025 updated by: Colleen Marie Feltmate, MD, Brigham and Women's Hospital
A Randomized, Controlled Trial Comparing Active vs. Passive Voiding Trials in a Gynecologic Oncologic Patient Population Undergoing Same-day Discharge Hysterectomy
The aim of this study is to investigate the impact of an active voiding trial compared to a passive voiding trial on time to discharge following a planned same day discharge laparoscopic hysterectomy.
The investigators hypothesize that performing an active voiding trial will assess urinary function and lead to a reduction in length of stay.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Following laparoscopic surgery with hysterectomy, there is no standard method for assuring urinary function prior to discharge.
Total laparoscopic hysterectomy (TLH) has been demonstrated to be safe with a reduction in post-operative morbidity and length of hospital stay with no difference in cancer related outcomes in endometrial cancer.
Furthermore, the investigators have demonstrated that following the adoption of same day discharge, there was no difference in composite complication rates or readmissions.
Awaiting a passive void trial may impact time to discharge as well as same day discharge; however, this has not been clearly studied in this patient population.
The aim of this study is to determine the difference in time to discharge following an active voiding trial with bladder backfill in the post-operative recovery unit compared to a passive voiding trial with removal of the Foley catheter in the operating room at the end of the procedure.
Secondary outcomes include time to void, catheter replacement, discomfort with the voiding trial, and overnight admission.
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients scheduled to undergo a total laparoscopic hysterectomy by a gynecologic oncology surgeon for either benign or malignant disease
- planned same day discharge surgery
Exclusion Criteria:
- history of significant urinary dysfunction (such as home catheterization) or neurologic dysfunction precluding spontaneous voiding
- bilateral radical pelvic dissection (defined as bilateral ureterolysis or removal of bilateral parametria)
- surgical cases converted to laparotomy or open surgery
- Surgical or medical contra-indications (based on the surgeons or anesthesiologists' recommendations) to same day discharge requiring inpatient admission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active Voiding Trial
At the completion of surgery, a Foley catheter was left in place.
When the patient was determined to be ambulatory by the recovery room nurse, the bladder was backfilled with 300cc of sterile normal saline.
Voiding 200cc or (2/3) of the backfill amount was considered passing.
|
|
|
No Intervention: Passive Voiding Trial
At the completion of surgery, a Foley catheter was removed in the operating room.
Study participants were allowed six hours to void spontaneously, with 200cc being considered adequate consistent with institution standard practice.
At the completion of six hours, if spontaneous voiding has not occurred, a bladder scan was performed and additional time was allowed based on bladder volume with criteria previously established as institution standards based on published practices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
length of hospital stay
Time Frame: within 24 hours (1440 minutes) following surgical procedure (while most participants are discharged on the same day some participants require overnight admission with length of stay up to 24 hours- though still measured in minutes)
|
Time (minutes) from the completion of surgery to discharge from the post-operative recovery unit
|
within 24 hours (1440 minutes) following surgical procedure (while most participants are discharged on the same day some participants require overnight admission with length of stay up to 24 hours- though still measured in minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to void
Time Frame: within 12 hours (720 minutes) following surgical procedure
|
Time (minutes) from Foley catheter removal to adequate voiding
|
within 12 hours (720 minutes) following surgical procedure
|
|
catheter replacement
Time Frame: within 24 hours (1440 minutes) following surgical procedure
|
failed trial of void (unable to void adequate volume 2/3rd of backfill or 200cc) requiring replacement of a Foley catheter for post-operative urinary retention
|
within 24 hours (1440 minutes) following surgical procedure
|
|
discomfort with voiding trial
Time Frame: within 12 hours (720 minutes) following surgical procedure
|
average pain scale as measured by Wong-Baker FACES Pain Rating Scale ranging from 0 to 10 with 0 being no pain and 10 being the worst pain.
|
within 12 hours (720 minutes) following surgical procedure
|
|
overnight admission
Time Frame: within 1 day following surgical procedure
|
planned same day discharge requiring an unplanned admission to the extended recovery unit (ERU)
|
within 1 day following surgical procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17.
- Lee J, Jennings K, Borahay MA, Rodriguez AM, Kilic GS, Snyder RR, Patel PR. Trends in the national distribution of laparoscopic hysterectomies from 2003 to 2010. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):656-61. doi: 10.1016/j.jmig.2014.01.012. Epub 2014 Jan 24.
- Pitter MC, Simmonds C, Seshadri-Kreaden U, Hubert HB. The impact of different surgical modalities for hysterectomy on satisfaction and patient reported outcomes. Interact J Med Res. 2014 Jul 17;3(3):e11. doi: 10.2196/ijmr.3160.
- Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Nov 10;27(32):5331-6. doi: 10.1200/JCO.2009.22.3248. Epub 2009 Oct 5.
- Melamed A, Katz Eriksen JL, Hinchcliff EM, Worley MJ Jr, Berkowitz RS, Horowitz NS, Muto MG, Urman RD, Feltmate CM. Same-Day Discharge After Laparoscopic Hysterectomy for Endometrial Cancer. Ann Surg Oncol. 2016 Jan;23(1):178-85. doi: 10.1245/s10434-015-4582-4. Epub 2015 May 9.
- Nahas S, Feigenberg T, Park S. Feasibility and safety of same-day discharge after minimally invasive hysterectomy in gynecologic oncology: A systematic review of the literature. Gynecol Oncol. 2016 Nov;143(2):439-442. doi: 10.1016/j.ygyno.2016.07.113. Epub 2016 Jul 27.
- Geller EJ. Prevention and management of postoperative urinary retention after urogynecologic surgery. Int J Womens Health. 2014 Aug 28;6:829-38. doi: 10.2147/IJWH.S55383. eCollection 2014.
- Foundation W-BF. Wong-Baker FACES® Pain Rating Scale. 2016
- Ghezzi F, Cromi A, Uccella S, Colombo G, Salvatore S, Tomera S, Bolis P. Immediate Foley removal after laparoscopic and vaginal hysterectomy: determinants of postoperative urinary retention. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):706-11. doi: 10.1016/j.jmig.2007.06.013.
- Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.
- Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.
- Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.
- 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.
- Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Barakat R, Pearl ML, Sharma SK. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J Clin Oncol. 2012 Mar 1;30(7):695-700. doi: 10.1200/JCO.2011.38.8645. Epub 2012 Jan 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
August 4, 2017
Study Completion (Actual)
August 4, 2017
Study Registration Dates
First Submitted
July 17, 2020
First Submitted That Met QC Criteria
July 24, 2020
First Posted (Actual)
July 27, 2020
Study Record Updates
Last Update Posted (Actual)
November 24, 2025
Last Update Submitted That Met QC Criteria
November 19, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P000902
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified patient data and voiding protocols will be made available upon request via email to other researchers
IPD Sharing Time Frame
Data will be available upon request until the time of publication.
IPD Sharing Access Criteria
requests should be made via the study contact email.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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