Trial Outcomes & Findings for Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial (NCT NCT03141372)
NCT ID: NCT03141372
Last Updated: 2018-10-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
post-operative day, about 4 hours post-surgery
Results posted on
2018-10-11
Participant Flow
Participant milestones
| Measure |
Autofill Void Trial
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR \> 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Backfill Void Trial
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR \> 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial
Baseline characteristics by cohort
| Measure |
Autofill Void Trial
n=42 Participants
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR \> 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Backfill Void Trial
n=40 Participants
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR \> 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
46 years
n=7 Participants
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
32.4 kg/m^2
n=5 Participants
|
28.8 kg/m^2
n=7 Participants
|
30.2 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: post-operative day, about 4 hours post-surgeryThe 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.
Outcome measures
| Measure |
Autofill Void Trial
n=42 Participants
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Backfill Void Trial
n=40 Participants
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
|---|---|---|
|
Number of Participants With Void Trial Failure Rate
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: post-operative day, about 4 hours post-surgeryThe 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.
Outcome measures
| Measure |
Autofill Void Trial
n=42 Participants
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Backfill Void Trial
n=40 Participants
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
|---|---|---|
|
Time to Discharge
|
176 minutes
Interval 160.5 to 255.5
|
218 minutes
Interval 180.0 to 265.0
|
SECONDARY outcome
Timeframe: 10-14 days post-surgeryAfter 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.
Outcome measures
| Measure |
Autofill Void Trial
n=42 Participants
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Backfill Void Trial
n=40 Participants
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
|---|---|---|
|
Number of Patients With Urinary Retention
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 14 days post-surgeryAny participant diagnosed with a culture-proven urinary tract infection will be noted.
Outcome measures
| Measure |
Autofill Void Trial
n=42 Participants
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Backfill Void Trial
n=40 Participants
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
|---|---|---|
|
Number of Participants With Post-Operative Urinary Tract Infection
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: pre-surgery and 14 days post-surgeryThe 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 all 1. \- Slightly 2. \- Moderately 3. \- Greatly The scores were added and divided by 7 to obtain an average score for each participant. Hence the range of scores is 0 to 3 with 0 being the best and 3 being the worst.
Outcome measures
| Measure |
Autofill Void Trial
n=42 Participants
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Backfill Void Trial
n=40 Participants
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
|---|---|---|
|
Quality of Bladder Function Using the Incontinence Impact Questionnaire
|
0 scores on a scale
Interval 0.0 to 1.75
|
0 scores on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: presurgery and at 10-14 days post-surgeryThe 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 and 5 being the worst scores.
Outcome measures
| Measure |
Autofill Void Trial
n=42 Participants
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Backfill Void Trial
n=40 Participants
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
|---|---|---|
|
Patient Perception of Bladder Condition Score
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: at 10-14 days post-surgeryParticipant 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.
Outcome measures
| Measure |
Autofill Void Trial
n=42 Participants
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
Backfill Void Trial
n=40 Participants
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The postvoid residual will be measured. If postvoid residual greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter: A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
|
|---|---|---|
|
Number of Participants Satisfied or Very Satisfied With Void Trial Using 5 Point Lickert Scale
|
39 Participants
|
30 Participants
|
Adverse Events
Autofill Void Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Backfill Void Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sara Farag, Fellow in Minimally Invasive Gynecologic Surgery
Cleveland Clinic Florida
Phone: 8147691904
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place