Post-Operative Voiding After Gynecological Surgery Trial

Not Applicable

Terminated

• Conditions: Urinary Retention; Postoperative Complications; Surgery
• Interventions: Procedure: Retrograde bladder filling

• Registration Number: NCT04198285
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-01-10
• Primary Completion: 2020-04-27
• Study Completion: 2020-04-27
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-16
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada