Trial Outcomes & Findings for Self-discontinuation of a Transurethral Catheter (NCT NCT02996968)
NCT ID: NCT02996968
Last Updated: 2019-11-12
Results Overview
Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse. Pour at 1-week was defined as continued catheterization on POD 6-8
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
158 participants
Primary outcome timeframe
postoperative day 6-8
Results posted on
2019-11-12
Participant Flow
Participant milestones
| Measure |
Self-discontinuation Group
The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
|
Office-discontinuation Group
The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
79
|
|
Overall Study
COMPLETED
|
78
|
79
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Self-discontinuation Group
The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
|
Office-discontinuation Group
The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Self-discontinuation of a Transurethral Catheter
Baseline characteristics by cohort
| Measure |
Self-discontinuation Group
n=78 Participants
The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
|
Office-discontinuation Group
n=79 Participants
The patients randomized to the discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=5 Participants
|
79 participants
n=7 Participants
|
157 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: postoperative day 6-8Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse. Pour at 1-week was defined as continued catheterization on POD 6-8
Outcome measures
| Measure |
Self-discontinuation Group
n=78 Participants
The patients randomized to the self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 7.
|
Office-discontinuation Group
n=79 Participants
The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 6-8 (postoperative day 7 will be encouraged). At this visit, the patients will undergo a backfill voiding trial.
|
|---|---|---|
|
Number of Participants With Postoperative Urinary Retention
|
11 Participants
|
11 Participants
|
Adverse Events
Self-discontinuation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Office-discontinuation Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place