Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery
Study Details
Study Description
Brief Summary
There is no general agreement about the optimal duration of postoperative urinary drainage, with relevant literature reporting durations ranging from 1 to 10 days. The available research supporting the routine use of prolonged catheterization is limited and studies investigating early removal following infraperitoneal colorectal surgery have largely been underpowered to form valid practice conclusions. The aim of the investigators study is to determine whether a postoperative colorectal patient can safely have an indwelling catheter removed on postoperative day one (24 hours following surgery) with the addition of a study medication (prazosin), without a statistically significant difference in the incidence of urinary retention compared to the standard, accepted approach of delayed removal (72 hours postoperatively). Patients undergoing laparoscopic and open pelvic colorectal surgery below the peritoneal reflection for both benign and malignant conditions will be randomized into two groups: group one will have the catheter removed on postoperative day 3 (72 hours postoperatively) Group 2 will have a dose of the alpha-blocker prazosin given 6 hours prior to catheter removal and will have the urinary catheter removed on postoperative day 1 (24 hours postoperatively).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The available research supporting the routine use of prolonged catheterization is limited and studies investigating early removal following infraperitoneal colorectal surgery have largely been underpowered to form valid practice conclusions. In the era of multimodal recovery algorithms emphasizing early diet advancement, ambulation, and shorter hospital length of stay, unnecessarily prolonging catheterization may interfere with many of these objectives. An indwelling urinary catheter interferes with early patient mobilization potentially lengthening hospitalization and subjects patients to an increased risk of urinary tract infection. A study of 2,355 consecutive patients undergoing primary colorectal cancer resection via laparotomy found an overall prevalence of postoperative urinary retention of 5.5%, however, those patients undergoing low pelvic surgery experience an almost 16% incidence in urinary retention.
Postoperative urinary catheter drainage after infraperitoneal colorectal surgery is commonly practiced, assuming some degree of nerve damage to the superior hypogastric plexus at the sacral promontory or of the nervi erigentes at the pelvic side wall resulting from pelvic dissection, causing transient or permanent dysfunction of the lower urinary tract. It has been believed that this intraoperative damage to the pelvic autonomic nerves may be associated with early postoperative acute urinary retention, and justifies an indwelling urinary catheter for several days following infraperitoneal pelvic surgery. However, there is no general agreement about the optimal duration of postoperative urinary drainage, with relevant literature reporting durations ranging from 1 to 10 days.
Prolonged indwelling urinary catheter has been associated with increased risk of urinary tract infections, with the risk of bacteriuria between 3 and 10% per day when catheterized, with the risk of urinary tract infection increasing by 5% to 10% per catheter day after the second day of catheterization. The incidence of urinary tract infections after anorectal surgery and 5 days of catheterization has been shown to range between 42% and 60%. Higher mortality rates have been reported in hospitalized patients who developed urinary tract infection after indwelling catheterization with the incidence of bacteremia after single catheterization reported to be as high as 8%.
The optimal duration of urinary drainage after infraperitoneal colorectal surgery is unknown. Based on the autonomic mechanisms of micturition in relation to the striated muscle fibers of the external urethral sphincter, alpha blockade has been studied as a potential intervention to reduce the incidence of re-catheterization. A large Cochrane Database reviewed their role in five randomized trials, with four trials favoring alpha blockade over placebo. Furthermore, the side-effect profile of alpha-blockade was low and compared favorably to placebo.
Prior studies have suggested urinary bladder catheter drainage removed on postoperative day one following pelvic surgery may be safe and decrease the incidence of urinary tract infection. However, the study was underpowered to detect meaningful conclusions. A larger study investigating the optimal duration of urinary drainage concluded that removing the catheter one day postoperatively in patients undergoing infraperitoneal colorectal surgery is appropriate, unless a low rectal carcinoma is present or lymph node metastatic disease is present. The investigators wish to further substantiate this evidence and introduce the positive findings associated with alpha-blockade in minimizing the need for re-catheterization.
The investigators therefore propose a prospective, controlled randomized trial to compare the effects of 1 day's transurethral catheterization after infraperitoneal surgery with an alpha blockade medication compared to those of 3 days of catheterization, with acute urinary retention as a primary endpoint.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 24 hour postop catheter removal group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively) |
Drug: 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)
Other Names:
|
| No Intervention: 72 hour postoperative catheter removal catheter removed on postoperative day 3 (72 hours postoperatively) |
Outcome Measures
Primary Outcome Measures
- Number of Participants With Acute Urinary Retention [Postoperative day 1 or postpoperative 3 depending on group randomization]
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.
Secondary Outcome Measures
- Number of Participants With a Symptomatic Urinary Tract Infection [During 1 week of hospitalization (prior to discharge)]
Urinary tract infection defined as symptomatic urinary complaints such as dysuria, with urinalysis consistent with infection.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
-
Males or females, >18 years of age inclusive at the time of study screening;
-
American Society of Anesthesiologists (ASA) Class I-III;
-
Infraperitoneal colorectal surgery (open and/or laparoscopic);
-
Elective Surgery
Exclusion Criteria:
-
Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
-
Children <18;
-
No perioperative antibiotics;
-
Past or current urinary tract malignancy;
-
Urinary catheter inserted before surgery;
-
Chronic kidney insufficiency with Creatinine> 2
-
Diagnosis of benign prostatic hyperplasia
-
Chronic urinary infections
-
Neurogenic bladder
-
History of enterovesical fistula
-
Pregnancy
-
Prior surgery of the lower urinary tract
-
Epidural
-
Perioperative ureteral stents
After randomization:
-
Catheter pulled out inadvertently;
-
Postoperative complications requiring prolonged monitoring of urine output
-
Postoperative complications requiring early reoperation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Cedars-Sinai Medical Center
Investigators
- Principal Investigator: Phillip Fleshner, MD, Cedars-Sinai Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 00029210
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 5 subjects were excluded. |
| Arm/Group Title | 24 Hour Postop Catheter Removal | 72 Hour Postoperative Catheter Removal |
|---|---|---|
| Arm/Group Description | 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) | catheter removed on postoperative day 3 (72 hours postoperatively) |
| Period Title: Overall Study | ||
| STARTED | 71 | 71 |
| COMPLETED | 71 | 71 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 24 Hour Postop Catheter Removal | 72 Hour Postoperative Catheter Removal | Total |
|---|---|---|---|
| Arm/Group Description | 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) | catheter removed on postoperative day 3 (72 hours postoperatively) | Total of all reporting groups |
| Overall Participants | 71 | 71 | 142 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
44.07
(16.9)
|
45.6
(17.8)
|
44.8
(16.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
31
43.7%
|
37
52.1%
|
68
47.9%
|
| Male |
40
56.3%
|
34
47.9%
|
74
52.1%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
5
7%
|
6
8.5%
|
11
7.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
1.4%
|
2
2.8%
|
3
2.1%
|
| White |
58
81.7%
|
59
83.1%
|
117
82.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
7
9.9%
|
4
5.6%
|
11
7.7%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
71
100%
|
71
100%
|
142
100%
|
| Body mass index (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
24.4
(4.9)
|
23.78
(4.2)
|
24.1
(9.1)
|
| American Society of Anesthesiologists Physical Status Classification (Count of Participants) | |||
| 1 |
3
4.2%
|
1
1.4%
|
4
2.8%
|
| 2 |
51
71.8%
|
51
71.8%
|
102
71.8%
|
| 3 |
15
21.1%
|
19
26.8%
|
34
23.9%
|
| 4 |
2
2.8%
|
0
0%
|
2
1.4%
|
| Surgery Indication (Count of Participants) | |||
| inflammatory bowel disease |
55
77.5%
|
48
67.6%
|
103
72.5%
|
| Cancer |
11
15.5%
|
19
26.8%
|
30
21.1%
|
| Prolapse |
3
4.2%
|
2
2.8%
|
5
3.5%
|
| Other |
2
2.8%
|
2
2.8%
|
4
2.8%
|
| Type of Surgery (Count of Participants) | |||
| IPAA |
53
74.6%
|
41
57.7%
|
94
66.2%
|
| LAR |
12
16.9%
|
14
19.7%
|
26
18.3%
|
| Rectopexy |
3
4.2%
|
3
4.2%
|
6
4.2%
|
| Other |
3
4.2%
|
13
18.3%
|
16
11.3%
|
| Surgical drain (Count of Participants) | |||
| Yes |
66
93%
|
57
80.3%
|
123
86.6%
|
| No |
5
7%
|
14
19.7%
|
19
13.4%
|
| intraoperative intravenous fluids (milliliters) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [milliliters] |
2855.6
(803)
|
2948.6
(857)
|
2901
(192)
|
| intraoperative estimated blood loss (milliliters) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [milliliters] |
182
(82)
|
201
(99)
|
192
(91)
|
| OR time (minutes) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [minutes] |
282
(66)
|
301
(61)
|
292
(191)
|
| peri-operative blood transfusion (Count of Participants) | |||
| yes |
1
1.4%
|
5
7%
|
6
4.2%
|
| no |
70
98.6%
|
66
93%
|
136
95.8%
|
| Total mesorectal excision (Count of Participants) | |||
| yes |
18
25.4%
|
16
22.5%
|
34
23.9%
|
| no |
53
74.6%
|
55
77.5%
|
108
76.1%
|
| neoadjuvant chemotherapy (Count of Participants) | |||
| yes |
5
7%
|
6
8.5%
|
11
7.7%
|
| no |
66
93%
|
65
91.5%
|
131
92.3%
|
| intravenous pain medications on post-operative day one (milligrams of hydromorphone) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [milligrams of hydromorphone] |
4.6
(1.73)
|
4.8
(1.65)
|
4.7
(1.7)
|
| mean pain score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.84
(1.09)
|
3.91
(1.09)
|
3.87
(1.1)
|
| The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer (Count of Participants) | |||
| 0 |
57
80.3%
|
51
71.8%
|
108
76.1%
|
| 1 |
8
11.3%
|
10
14.1%
|
18
12.7%
|
| 2A |
4
5.6%
|
3
4.2%
|
7
4.9%
|
| 2B |
0
0%
|
0
0%
|
0
0%
|
| 2c |
0
0%
|
1
1.4%
|
1
0.7%
|
| 3a |
1
1.4%
|
3
4.2%
|
4
2.8%
|
| 3b |
1
1.4%
|
3
4.2%
|
4
2.8%
|
Outcome Measures
| Title | Number of Participants With Acute Urinary Retention |
|---|---|
| Description | 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. |
| Time Frame | Postoperative day 1 or postpoperative 3 depending on group randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 24 Hour Postop Catheter Removal | 72 Hour Postoperative Catheter Removal |
|---|---|---|
| Arm/Group Description | 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) | catheter removed on postoperative day 3 (72 hours postoperatively) |
| Measure Participants | 71 | 71 |
| Count of Participants [Participants] |
6
8.5%
|
7
9.9%
|
| Title | Number of Participants With a Symptomatic Urinary Tract Infection |
|---|---|
| Description | Urinary tract infection defined as symptomatic urinary complaints such as dysuria, with urinalysis consistent with infection. |
| Time Frame | During 1 week of hospitalization (prior to discharge) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 24 Hour Postop Catheter Removal | 72 Hour Postoperative Catheter Removal |
|---|---|---|
| Arm/Group Description | 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) | catheter removed on postoperative day 3 (72 hours postoperatively) |
| Measure Participants | 71 | 71 |
| Count of Participants [Participants] |
0
0%
|
8
11.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 24 Hour Postop Catheter Removal, 72 Hour Postoperative Catheter Removal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | The primary outcome of interest was the rate of AUR, defined as the number of patients with AUR within each study group. A 15% non-inferiority margin was chosen according to clinical relevance estimation. The expected difference between the two groups was 0%. Non-inferiority analysis was performed by calculation of risk difference and its 95% confidence interval according to Newcombe & Altman. | |
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Adverse Events
| Time Frame | 72 hours | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Methods did not differ from definitions provided by clinicaltrials.gov | |||
| Arm/Group Title | 24 Hour Postop Catheter Removal | 72 Hour Postoperative Catheter Removal | ||
| Arm/Group Description | 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) | catheter removed on postoperative day 3 (72 hours postoperatively) | ||
All Cause Mortality |
||||
| 24 Hour Postop Catheter Removal | 72 Hour Postoperative Catheter Removal | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/71 (0%) | 0/71 (0%) | ||
Serious Adverse Events |
||||
| 24 Hour Postop Catheter Removal | 72 Hour Postoperative Catheter Removal | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/71 (0%) | 0/71 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| 24 Hour Postop Catheter Removal | 72 Hour Postoperative Catheter Removal | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/71 (8.5%) | 0/71 (0%) | ||
| Cardiac disorders | ||||
| Dizziness | 6/71 (8.5%) | 6 | 0/71 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Phillip Fleshner |
|---|---|
| Organization | Cedars Sinai Medical Center |
| Phone | (310) 289-9224 |
| Phillip.Fleshner@cshs.org |
- 00029210