POVAGS: Post-Operative Voiding After Gynecological Surgery Trial

Sponsor

Women's College Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT04198285

Collaborator

(none)

Enrollment

Location

Arms

3.5

Actual Duration (Months)

11.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention Postoperative Complications Surgery	Procedure: Retrograde bladder filling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 10, 2020

Actual Primary Completion Date :

Apr 27, 2020

Actual Study Completion Date :

Apr 27, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Time to first void [3 hours]
Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's College Hospital	Toronto	Ontario	Canada	M5S 1B2

Sponsors and Collaborators

Women's College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Jonathon Solnik, Site Chief of Gynecology, Women's College Hospital

ClinicalTrials.gov Identifier:

NCT04198285

Other Study ID Numbers:

2019-0110-E

First Posted:

Dec 13, 2019

Last Update Posted:

Aug 18, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jonathon Solnik, Site Chief of Gynecology, Women's College Hospital

laparoscopy, urinary retention

Additional relevant MeSH terms:

Urinary Retention

Postoperative Complications

Study Results

No Results Posted as of Aug 18, 2020