Post-Operative Voiding After Gynecological Surgery Trial (POVAGS)

Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy

To determine whether partially filling the bladder after outpatient gynaecological laparoscopy expedites time to first void and discharge. Methods: A single site, single-blinded, randomized control trial in which eligible patients undergo partial retrograde bladder filling immediately post-operatively compared to bladder drainage and foley catheter removal. Primary outcome is time to first void, secondary outcomes include time to discharge, post-operative complications and patient satisfaction.

Study Overview

• Status: Terminated
• Conditions: Postoperative Complications; Surgery; Urinary Retention
• Intervention / Treatment: Procedure: Retrograde bladder filling

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women
• Undergoing elective laparoscopy for a gynaecological indication
• Plan for same day discharge
• Able to provide informed consent

Exclusion Criteria:

• Pregnancy
• Undergoing procedure for pelvic organ prolapse, stress urinary incontinence, or nerve detrapment
• Prior hysterectomy, or incontinence/pelvic organ prolapse procedures
• Pre-existing voiding dysfunction
• Known recurrent urinary tract infections
• Known genito-urinary malformations
• Known for neuromuscular disorders such as multiple sclerosis
• Use of anticholinergic medication
• Intraoperative bladder related complications
• Need for discharge with indwelling foley catheter
• Patients requiring overnight admission for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Retrograde filled; This arm will contain patients who had retrograde bladder filling upon completion of surgery with 200 milliliters (mL) of sterile saline.	Procedure: Retrograde bladder filling; The bladder will be filled with a large syringe through the urinary catheter (which is left in place for the surgery) with 200mL of sterile saline, and then the catheter will be removed.
NO_INTERVENTION: Control; This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first void	Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discharge	Time in minutes from arrival in PACU to discharge from PACU	8 hours
Post-operative complications	Urinary tract infections, or other reported complications	1 week following surgery
Patient satisfaction	Patients' subjective experience in both groups regarding time spent in PACU and first postoperative week	1 week
Post-operative pain	visual analogue scale of postoperative pain, assessed in PACU	Assessed at the 1 hour mark

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Investigators: Principal Investigator: Ally Murji, MD, Women's College Hospital

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.
• Zakhari A, Paek W, Chan W, Edwards D, Matelski J, Solnik MJ, Murji A. Retrograde Bladder Filling after Laparoscopic Gynecologic Surgery: A Double-blind Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 May;28(5):1006-1012.e1. doi: 10.1016/j.jmig.2020.09.019. Epub 2020 Oct 3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2020
• Primary Completion (ACTUAL): April 27, 2020
• Study Completion (ACTUAL): April 27, 2020

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 16, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: laparoscopy, urinary retention
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urination Disorders; Postoperative Complications; Urinary Retention
• Other Study ID Numbers: 2019-0110-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No