NCT04198285

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

December 12, 2019

Last Update Submit

August 16, 2020

Conditions

Urinary RetentionPostoperative ComplicationsSurgery

Keywords

laparoscopy, urinary retention

Outcome Measures

Primary Outcomes (1)

  • Time to first void

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

    3 hours

Secondary Outcomes (4)

  • Time to discharge

    8 hours

  • Post-operative complications

    1 week following surgery

  • Patient satisfaction

    1 week

  • Post-operative pain

    Assessed at the 1 hour mark

Study Arms (2)

Retrograde filled

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Retrograde bladder fillingPROCEDURE

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.

Retrograde filled

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatients undergoing gynecological surgery
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 30639089BACKGROUND

  • 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.

    PMID: 33017685DERIVED

MeSH Terms

Conditions

Urinary RetentionPostoperative Complications

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ally Murji, MD

    Women's College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Site Chief of Gynecology

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 13, 2019

Study Start

January 10, 2020

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)