Post-Operative Voiding After Gynecological Surgery Trial

Surgery Clinical Trial

— POVAGS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04198285
• Other study ID #: 2019-0110-E
• Status: Terminated
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: April 27, 2020

Study information

• Verified date: August 2020
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Surgery
• Urinary Retention

Intervention

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.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first void	Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void	3 hours
Secondary	Time to discharge	Time in minutes from arrival in PACU to discharge from PACU	8 hours
Secondary	Post-operative complications	Urinary tract infections, or other reported complications	1 week following surgery
Secondary	Patient satisfaction	Patients' subjective experience in both groups regarding time spent in PACU and first postoperative week	1 week
Secondary	Post-operative pain	visual analogue scale of postoperative pain, assessed in PACU	Assessed at the 1 hour mark