Trial Outcomes & Findings for Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery (NCT NCT01923129)
NCT ID: NCT01923129
Last Updated: 2019-02-20
Results Overview
Acute urinary retention will be defined as catheter discontinuation with inability to void 6 hours post-removal, or void with post-void residual greater than 200 cc of urine.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
Postoperative day 1 or postpoperative 3 depending on group randomization
Results posted on
2019-02-20
Participant Flow
5 subjects were excluded.
Participant milestones
| Measure |
24 Hour Postop Catheter Removal
group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)
Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
|
72 Hour Postoperative Catheter Removal
catheter removed on postoperative day 3 (72 hours postoperatively)
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
71
|
|
Overall Study
COMPLETED
|
71
|
71
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery
Baseline characteristics by cohort
| Measure |
24 Hour Postop Catheter Removal
n=71 Participants
group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)
Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
|
72 Hour Postoperative Catheter Removal
n=71 Participants
catheter removed on postoperative day 3 (72 hours postoperatively)
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.07 years
STANDARD_DEVIATION 16.9 • n=93 Participants
|
45.6 years
STANDARD_DEVIATION 17.8 • n=4 Participants
|
44.8 years
STANDARD_DEVIATION 16.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
117 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=93 Participants
|
71 participants
n=4 Participants
|
142 participants
n=27 Participants
|
|
Body mass index
|
24.4 kg/m^2
STANDARD_DEVIATION 4.9 • n=93 Participants
|
23.78 kg/m^2
STANDARD_DEVIATION 4.2 • n=4 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 9.1 • n=27 Participants
|
|
American Society of Anesthesiologists Physical Status Classification
1
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
American Society of Anesthesiologists Physical Status Classification
2
|
51 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
|
American Society of Anesthesiologists Physical Status Classification
3
|
15 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
American Society of Anesthesiologists Physical Status Classification
4
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Surgery Indication
inflammatory bowel disease
|
55 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Surgery Indication
Cancer
|
11 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Surgery Indication
Prolapse
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Surgery Indication
Other
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Type of Surgery
IPAA
|
53 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
Type of Surgery
LAR
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Type of Surgery
Rectopexy
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Type of Surgery
Other
|
3 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Surgical drain
Yes
|
66 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
123 Participants
n=27 Participants
|
|
Surgical drain
No
|
5 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
intraoperative intravenous fluids
|
2855.6 milliliters
STANDARD_DEVIATION 803 • n=93 Participants
|
2948.6 milliliters
STANDARD_DEVIATION 857 • n=4 Participants
|
2901 milliliters
STANDARD_DEVIATION 192 • n=27 Participants
|
|
intraoperative estimated blood loss
|
182 milliliters
STANDARD_DEVIATION 82 • n=93 Participants
|
201 milliliters
STANDARD_DEVIATION 99 • n=4 Participants
|
192 milliliters
STANDARD_DEVIATION 91 • n=27 Participants
|
|
OR time
|
282 minutes
STANDARD_DEVIATION 66 • n=93 Participants
|
301 minutes
STANDARD_DEVIATION 61 • n=4 Participants
|
292 minutes
STANDARD_DEVIATION 191 • n=27 Participants
|
|
peri-operative blood transfusion
yes
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
peri-operative blood transfusion
no
|
70 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
|
Total mesorectal excision
yes
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Total mesorectal excision
no
|
53 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
neoadjuvant chemotherapy
yes
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
neoadjuvant chemotherapy
no
|
66 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
131 Participants
n=27 Participants
|
|
intravenous pain medications on post-operative day one
|
4.6 milligrams of hydromorphone
STANDARD_DEVIATION 1.73 • n=93 Participants
|
4.8 milligrams of hydromorphone
STANDARD_DEVIATION 1.65 • n=4 Participants
|
4.7 milligrams of hydromorphone
STANDARD_DEVIATION 1.7 • n=27 Participants
|
|
mean pain score
|
3.84 units on a scale
STANDARD_DEVIATION 1.09 • n=93 Participants
|
3.91 units on a scale
STANDARD_DEVIATION 1.09 • n=4 Participants
|
3.87 units on a scale
STANDARD_DEVIATION 1.1 • n=27 Participants
|
|
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
0
|
57 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
1
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
2A
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
2B
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
2c
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
3a
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
3b
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 1 or postpoperative 3 depending on group randomizationAcute urinary retention will be defined as catheter discontinuation with inability to void 6 hours post-removal, or void with post-void residual greater than 200 cc of urine.
Outcome measures
| Measure |
24 Hour Postop Catheter Removal
n=71 Participants
group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)
Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
|
72 Hour Postoperative Catheter Removal
n=71 Participants
catheter removed on postoperative day 3 (72 hours postoperatively)
|
|---|---|---|
|
Number of Participants With Acute Urinary Retention
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: During 1 week of hospitalization (prior to discharge)Urinary tract infection defined as symptomatic urinary complaints such as dysuria, with urinalysis consistent with infection.
Outcome measures
| Measure |
24 Hour Postop Catheter Removal
n=71 Participants
group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)
Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
|
72 Hour Postoperative Catheter Removal
n=71 Participants
catheter removed on postoperative day 3 (72 hours postoperatively)
|
|---|---|---|
|
Number of Participants With a Symptomatic Urinary Tract Infection
|
0 Participants
|
8 Participants
|
Adverse Events
24 Hour Postop Catheter Removal
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
72 Hour Postoperative Catheter Removal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
24 Hour Postop Catheter Removal
n=71 participants at risk
group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)
Prazosin given 6 hours prior to catheter removal in the 24 hour group: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
|
72 Hour Postoperative Catheter Removal
n=71 participants at risk
catheter removed on postoperative day 3 (72 hours postoperatively)
|
|---|---|---|
|
Cardiac disorders
Dizziness
|
8.5%
6/71 • Number of events 6 • 72 hours
Methods did not differ from definitions provided by clinicaltrials.gov
|
0.00%
0/71 • 72 hours
Methods did not differ from definitions provided by clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place