The Effect of Partial Bladder Filling on Post-operative Time to Void in Minimally Invasive Gynecologic Procedures

The purpose of this study is to determine if partially filling the bladder after laparoscopic/robotic gynecologic surgery (for benign disease) shortens the time required to spontaneously void for patients to determine if this subsequently shortens patient stay times in the Post Anesthesia Care Unit (PACU) following surgery. This intervention would be compared to the current standard of care, which involves removing the patient's Foley catheter with an empty bladder and then giving the patient up to 6 hours to void in the PACU.

Study Overview

• Status: Completed
• Conditions: Hysterectomy; Myomectomy
• Intervention / Treatment: Other: Bladder filled with saline solution; Other: saline solution

Detailed Description

Patients undergoing laparoscopic/robotic hysterectomy or myomectomy who meet the study criteria will be contacted by the research assistant at a pre-operative visit. The risks and benefits of participation will be explained to them. If they choose to participate they will sign the consent form at that time.

At the time of the surgery, the research coordinator will open a sealed envelope containing the patient's assignment to partial bladder filling or no bladder filling. The research coordinator will then notify the surgeon via secure phone call or secure messaging service and the patient/subject will have their bladder partially filled or completely emptied as relayed to the surgeon at the end of the procedure in the Operating Room, unless there are issues of patient safety or operative complications. In the patients who are chosen for partial bladder filling, the bladder will be back-filled with 150 cc of normal saline and then the Foley catheter will be removed at the end of the procedure. In patients who have no bladder filling, the bladder will be completely emptied and then the Foley catheter will be removed. One of the providers who perform the gynecological surgical procedures will be responsible for back-filling or completely emptying the bladder with the Foley catheter.

The patients will be followed in the PACU to determine the time it takes for them to void. The will also be followed for any complications until they are four weeks post surgery. The electronic medical record will be examined to see if they have any complications reported at their post-operative visits or any readmissions to the hospital.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Faculty Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Hysterectomy or myomectomy planned for a benign gynecologic reason. (This means that there is no evidence of, or concern for, malignancy in the cervix, uterus, tubes or ovaries. Benign gynecologic reasons to have a hysterectomy include fibroids, abnormal uterine bleeding, endometriosis, and pelvic pain. Benign reason for myomectomy would be fibroids)
2. Patient is scheduled to have surgery with one of the minimally invasive gynecologic surgeons at George Washington University Hospital (GWUH)
3. Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH) or robotic assisted or laparoscopic myomectomy.
4. Patient is capable of informed consent.
5. The patient has no baseline urinary disease.

Exclusion Criteria:

1. Hysterectomy or myomectomy is indicated for malignancy
2. Hysterectomy or myomectomy is not being performed via robotic or laparoscopic method
3. Patient is not capable of providing informed consent
4. Patient has urinary disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients in this group will have their bladder filled with 150 cubic centimeters (cc) of saline solution prior to being moved to the PACU.	Other: Bladder filled with saline solution; Patients in this arm will have their bladders filled with 150 cc of saline solution.; Other: saline solution; Saline solution will be used to partially fill patients' bladders
No Intervention: Control; patients in this group will have their bladders drained completely prior to being moved to the PACU as is the current standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Void	the time (in minutes) between when the patient's foley is removed and when the patient is able to void in the PACU.	peri-operative

Collaborators and Investigators

• Sponsor: George Washington University

Publications and helpful links

General Publications

• Moawad G, Tyan P, Marfori C, Abi Khalil E, Park D. Effect of postoperative partial bladder filling after minimally invasive hysterectomy on postanesthesia care unit discharge and cost: a single-blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Apr;220(4):367.e1-367.e7. doi: 10.1016/j.ajog.2018.12.034. Epub 2019 Jan 9.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): July 27, 2017
• Study Completion (Actual): July 27, 2017

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: 121536