Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Women's College Hospital
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Time to first void
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Retrograde filled
This arm will contain patients who had retrograde bladder filling upon completion of surgery with 200 milliliters (mL) of sterile saline.
Intervention: Retrograde bladder filling (Procedure)
Control
This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder.
Outcomes
Primary Outcomes
Time to first void
Time Frame: 3 hours
Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void
Secondary Outcomes
- 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)
Investigators
Jonathon Solnik
Site Chief of Gynecology
Women's College Hospital