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Post-Operative Voiding After Gynecological Surgery Trial (POVAGS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04198285
Recruitment Status : Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathon Solnik, Women's College Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Time to first void [ Time Frame: 3 hours ]
    Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void


Secondary Outcome Measures :
  1. Time to discharge [ Time Frame: 8 hours ]
    Time in minutes from arrival in PACU to discharge from PACU

  2. Post-operative complications [ Time Frame: 1 week following surgery ]
    Urinary tract infections, or other reported complications

  3. Patient satisfaction [ Time Frame: 1 week ]
    Patients' subjective experience in both groups regarding time spent in PACU and first postoperative week

  4. Post-operative pain [ Time Frame: Assessed at the 1 hour mark ]
    visual analogue scale of postoperative pain, assessed in PACU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   patients undergoing gynecological surgery
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198285


Contacts
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Contact: Andrew Zakhari, MD 5147937921 andrew.zakhari@mail.mcgill.ca
Contact: Ally Murji, MD 4165651050 ally.murji@gmail.com

Sponsors and Collaborators
Women's College Hospital
Investigators
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Principal Investigator: Ally Murji, MD Women's College Hospital

Publications:
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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: December 13, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathon Solnik, Women's College Hospital:
laparoscopy, urinary retention
Additional relevant MeSH terms:
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Urinary Retention
Postoperative Complications
Pathologic Processes
Urination Disorders
Urologic Diseases