Post-Operative Voiding After Gynecological Surgery Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Retention, Postoperative Complications, Surgery

Intervention / Treatment
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* Procedure: Retrograde bladder filling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retrograde filled<br>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<br>* 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.<br>|
| No Intervention: Control<br>This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first void | Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge | Time in minutes from arrival in PACU to discharge from PACU | 8 hours | 
| Post-operative complications | Urinary tract infections, or other reported complications | 1 week following surgery | 
| Patient satisfaction | Patients' subjective experience in both groups regarding time spent in PACU and first postoperative week | 1 week | 
| Post-operative pain | visual analogue scale of postoperative pain, assessed in PACU | Assessed at the 1 hour mark | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, urinary retention