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Post-Operative Voiding After Gynecological Surgery Trial (POVAGS)

Primary Purpose

Urinary Retention, Postoperative Complications, Surgery

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Retrograde bladder filling
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Retention focused on measuring laparoscopy, urinary retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Women's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Retrograde filled

Control

Arm Description

This arm will contain patients who had retrograde bladder filling upon completion of surgery with 200 milliliters (mL) of sterile saline.

This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder.

Outcomes

Primary Outcome Measures

Time to first void
Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void

Secondary Outcome Measures

Time to discharge
Time in minutes from arrival in PACU to discharge from PACU
Post-operative complications
Urinary tract infections, or other reported complications
Patient satisfaction
Patients' subjective experience in both groups regarding time spent in PACU and first postoperative week
Post-operative pain
visual analogue scale of postoperative pain, assessed in PACU

Full Information

First Posted
December 12, 2019
Last Updated
August 16, 2020
Sponsor
Women's College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04198285
Brief Title
Post-Operative Voiding After Gynecological Surgery Trial
Acronym
POVAGS
Official Title
Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to cancellation of elective surgery (Covid-19)
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women's College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Postoperative Complications, Surgery
Keywords
laparoscopy, urinary retention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retrograde filled
Arm Type
Experimental
Arm Description
This arm will contain patients who had retrograde bladder filling upon completion of surgery with 200 milliliters (mL) of sterile saline.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder.
Intervention Type
Procedure
Intervention Name(s)
Retrograde bladder filling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to first void
Description
Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Time to discharge
Description
Time in minutes from arrival in PACU to discharge from PACU
Time Frame
8 hours
Title
Post-operative complications
Description
Urinary tract infections, or other reported complications
Time Frame
1 week following surgery
Title
Patient satisfaction
Description
Patients' subjective experience in both groups regarding time spent in PACU and first postoperative week
Time Frame
1 week
Title
Post-operative pain
Description
visual analogue scale of postoperative pain, assessed in PACU
Time Frame
Assessed at the 1 hour mark

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
patients undergoing gynecological surgery
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ally Murji, MD
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30639089
Citation
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.
Results Reference
background
PubMed Identifier
33017685
Citation
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.
Results Reference
derived

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Post-Operative Voiding After Gynecological Surgery Trial

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