Trial Outcomes & Findings for Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery (NCT NCT00392210)
NCT ID: NCT00392210
Last Updated: 2017-04-27
Results Overview
Voiding trial 1 was performed according to the patient assignment to group 1 or 2. Voiding trial 2 was done immediately after completion of trial 1. A successful trial was defined as a void of greater than two-thirds of total bladder volume (voided volume + post-void residual urine).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
postoperatively after surgery on day1 or 2
Results posted on
2017-04-27
Participant Flow
271 potential subjects were identified. 192 declined participation so 79 were enrolled.
10 subjects were withdrawn prior to randomization
Participant milestones
| Measure |
Auto-fill Followed by Back Fill
The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
|
Back Fill Followed by Autofill
The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
|
|---|---|---|
|
First Voiding Trial
STARTED
|
36
|
33
|
|
First Voiding Trial
COMPLETED
|
34
|
31
|
|
First Voiding Trial
NOT COMPLETED
|
2
|
2
|
|
Second Voiding Trial
STARTED
|
34
|
31
|
|
Second Voiding Trial
COMPLETED
|
34
|
31
|
|
Second Voiding Trial
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Auto-fill Followed by Back Fill
The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
|
Back Fill Followed by Autofill
The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
|
|---|---|---|
|
First Voiding Trial
Physician Decision
|
2
|
2
|
Baseline Characteristics
Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery
Baseline characteristics by cohort
| Measure |
Auto Fill Followed by Back Fill
n=41 Participants
The Auto fill-method was performed immediately followed by the back-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
|
Back Fill Followed by Auto Fill
n=38 Participants
The back fill-method was performed immediately followed by the auto-fill method. Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void. Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
60.73 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
57.58 years
STANDARD_DEVIATION 10.04 • n=7 Participants
|
59.02 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
38 participants
n=7 Participants
|
79 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: postoperatively after surgery on day1 or 2Voiding trial 1 was performed according to the patient assignment to group 1 or 2. Voiding trial 2 was done immediately after completion of trial 1. A successful trial was defined as a void of greater than two-thirds of total bladder volume (voided volume + post-void residual urine).
Outcome measures
| Measure |
Auto Fill Intervention
n=65 Participants
Auto fill: The catheter was removed and the bladder was allowed to fill spontaneously until the patient experienced a strong urge to void.
|
Back Fill Intervention
n=65 Participants
Back Fill: The bladder was filled retrograde through the indwelling Foley catheter with 300 cc sterile saline or until the patient reported a strong urge whichever occurred first.
|
|---|---|---|
|
Number of Participants Who Passed Bladder Trial
|
25 participants
|
39 participants
|
Adverse Events
Auto Fill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Back Fill
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
Michael K. Flynn, MD
University of Rochester
Phone: 585-273-3232
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place