Post-Operative Voiding After Gynecological Surgery Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2020-04-27

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.

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Detailed Description

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Conditions

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Urinary Retention Postoperative Complications Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Retrograde filled

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

Group Type EXPERIMENTAL

Retrograde bladder filling

Intervention Type PROCEDURE

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.

Control

This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes