NCT03141372

Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial

Completed NA Results posted Last updated 11 October 2018

What this trial tests

NA trial testing Void Trial using Foley catheter in Urinary Retention in 84 participants. Completed in 30 April 2018.

Timeline

16 May 2017

Primary endpoint
30 April 2018

30 April 2018

Quick facts

Lead sponsor	Sara Farag
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	84
Start date	16 May 2017
Primary completion	30 April 2018
Estimated completion	30 April 2018
Sites	1 location across United States

Drugs / interventions tested

• Void Trial using Foley catheter

Conditions studied

• Urinary Retention — all drugs for Urinary Retention →
• Voiding Disorders — all drugs for Voiding Disorders →

Sponsor

Sara Farag

Who can join

18 and older, female only, with Urinary Retention or Voiding Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Void Trial Failure Rate Primary · post-operative day, about 4 hours post-surgery

The primary endpoint of this study will be to determine if the rate of void trial failure after total laparoscopic hysterectomy is different after the autofill method versus the backfill method.

Group	Value	95% CI
Autofill Void Trial	7
Backfill Void Trial	11

Time to Discharge Secondary · post-operative day, about 4 hours post-surgery

The time to discharge will be measured for each participant. This will be determined by calculating the time between arrival to the post-anesthesia care unit and the time of discharge using documentation from Epic and from the case report forms.

Group	Value	95% CI
Autofill Void Trial	176	160.5 – 255.5
Backfill Void Trial	218	180 – 265

Number of Patients With Urinary Retention Secondary · 10-14 days post-surgery

After discharge, participants will be monitored for any encounters for urinary retention (in our hospital system) and will be asked at their 10-14 day post-operative visit if they had a Foley catheter placed outside the hospital. Additionally, any participant who fails their 2nd void trial will be noted. The incidence of urinary retention post-discharge will be determined using this data.

Group	Value	95% CI
Autofill Void Trial	1
Backfill Void Trial	1

Number of Participants With Post-Operative Urinary Tract Infection Secondary · up to 14 days post-surgery

Any participant diagnosed with a culture-proven urinary tract infection will be noted.

Group	Value	95% CI
Autofill Void Trial	2
Backfill Void Trial	1

Quality of Bladder Function Using the Incontinence Impact Questionnaire Secondary · pre-surgery and 14 days post-surgery

The Incontinence Impact Questionnaire-7 will be used to determine if there are any changes to the participants' short term quality of life before and after surgery. The questionnaire includes 7 questions asking how the participant's bladder function has affected her: 1. Ability to do household chores. 2. Physical recreation 3. Entertainment activities 4. Ability to travel by car or bus more than 30 minutes from home 5. Participation in social activities outside the home 6. Emotional health 7. Feeling frustrated The patient scores each of the questions using the following scale: 0 - Not at a

Group	Value	95% CI
Autofill Void Trial	0	0 – 1.75
Backfill Void Trial	0	0 – 0

Patient Perception of Bladder Condition Score Secondary · presurgery and at 10-14 days post-surgery

The Patient Perception of Bladder Condition will be used to determine if there are any changes to the participants' perception of bladder function before and after surgery. In this questionnaire, the participant answers one question as follows: My bladder condition: 0 - Does not cause me any problems at all 1. \- Causes me very minor problems 2. \- Causes me some minor problems 3. \- Causes me (some) moderate problems 4. \- Causes me severe problems 5. \- Causes me many severe problems The score was recorded for each patient. The range of possible scores were 0 to 5 with 0 being the best

Group	Value	95% CI
Autofill Void Trial	0	0 – 1
Backfill Void Trial	0	0 – 1

Number of Participants Satisfied or Very Satisfied With Void Trial Using 5 Point Lickert Scale Secondary · at 10-14 days post-surgery

Participant satisfaction level with the method of void trial will be collected at the 10-14 day post-operative visit and compared between the two methods of void trial.

Group	Value	95% CI
Autofill Void Trial	39
Backfill Void Trial	30

Sponsor's own description

Acute urinary retention is a complication of hysterectomies that can result in bladder over-distension and long term bladder dysfunction. The incidence of acute urinary retention after total laparoscopic hysterectomy (TLH) has been reported to be anywhere between 4% and 34%. Studies have varied in the method of post-operative bladder challenge and the modality of hysterectomy included. Moreover, most of the published studies are retrospective chart reviews or prospective observational studies, with a lack of randomized controlled trials. Risk factors for urinary retention include type of anesthesia used, how the hysterectomy is performed, use of post-operative narcotics, pre-operative urinary retention, and possibly aggressive bladder dissection. With the increased trend towards same-day discharge following TLH, urinary retention may cause unnecessary patient distress and a worsened post-operative course. Standardization of post-hysterectomy bladder challenge and identification of risk factors for urinary retention may aid in preventing urinary retention or acute bladder dysfunction. The primary objective is to compare the rate of void trial failure after TLH with the backfill technique versus the autofill technique.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.