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Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery

Prospective Study Investigating Optimal Duration of Indwelling Urinary Catheter Following Infraperitoneal Colorectal Surgery and Role of Postoperative Alpha Blockade

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01923129
Enrollment
142
Registered
2013-08-15
Start date
2012-11-30
Completion date
2017-11-22
Last updated
2019-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention

Keywords

indwelling catheter, foley, duration

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).

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.

Interventions

DRUGPrazosin 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)

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form; 2. Males or females, \>18 years of age inclusive at the time of study screening; 3. American Society of Anesthesiologists (ASA) Class I-III; 4. Infraperitoneal colorectal surgery (open and/or laparoscopic); 5. Elective Surgery

Exclusion criteria

1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures; 2. Children \<18; 3. No perioperative antibiotics; 4. Past or current urinary tract malignancy; 5. Urinary catheter inserted before surgery; 6. Chronic kidney insufficiency with Creatinine\> 2 7. Diagnosis of benign prostatic hyperplasia 8. Chronic urinary infections 9. Neurogenic bladder 10. History of enterovesical fistula 11. Pregnancy 12. Prior surgery of the lower urinary tract 13. Epidural 14. Perioperative ureteral stents After randomization: 1. Catheter pulled out inadvertently; 2. Postoperative complications requiring prolonged monitoring of urine output 3. Postoperative complications requiring early reoperation

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Acute Urinary RetentionPostoperative 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.

Secondary

MeasureTime frameDescription
Number of Participants With a Symptomatic Urinary Tract InfectionDuring 1 week of hospitalization (prior to discharge)Urinary tract infection defined as symptomatic urinary complaints such as dysuria, with urinalysis consistent with infection.

Countries

United States

Participant flow

Pre-assignment details

5 subjects were excluded.

Participants by arm

ArmCount
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)
71
72 Hour Postoperative Catheter Removal
catheter removed on postoperative day 3 (72 hours postoperatively)
71
Total142

Baseline characteristics

CharacteristicTotal24 Hour Postop Catheter Removal72 Hour Postoperative Catheter Removal
Age, Continuous44.8 years
STANDARD_DEVIATION 16.9
44.07 years
STANDARD_DEVIATION 16.9
45.6 years
STANDARD_DEVIATION 17.8
American Society of Anesthesiologists Physical Status Classification
1
4 Participants3 Participants1 Participants
American Society of Anesthesiologists Physical Status Classification
2
102 Participants51 Participants51 Participants
American Society of Anesthesiologists Physical Status Classification
3
34 Participants15 Participants19 Participants
American Society of Anesthesiologists Physical Status Classification
4
2 Participants2 Participants0 Participants
Body mass index24.1 kg/m^2
STANDARD_DEVIATION 9.1
24.4 kg/m^2
STANDARD_DEVIATION 4.9
23.78 kg/m^2
STANDARD_DEVIATION 4.2
intraoperative estimated blood loss192 milliliters
STANDARD_DEVIATION 91
182 milliliters
STANDARD_DEVIATION 82
201 milliliters
STANDARD_DEVIATION 99
intraoperative intravenous fluids2901 milliliters
STANDARD_DEVIATION 192
2855.6 milliliters
STANDARD_DEVIATION 803
2948.6 milliliters
STANDARD_DEVIATION 857
intravenous pain medications on post-operative day one4.7 milligrams of hydromorphone
STANDARD_DEVIATION 1.7
4.6 milligrams of hydromorphone
STANDARD_DEVIATION 1.73
4.8 milligrams of hydromorphone
STANDARD_DEVIATION 1.65
mean pain score3.87 units on a scale
STANDARD_DEVIATION 1.1
3.84 units on a scale
STANDARD_DEVIATION 1.09
3.91 units on a scale
STANDARD_DEVIATION 1.09
neoadjuvant chemotherapy
no
131 Participants66 Participants65 Participants
neoadjuvant chemotherapy
yes
11 Participants5 Participants6 Participants
OR time292 minutes
STANDARD_DEVIATION 191
282 minutes
STANDARD_DEVIATION 66
301 minutes
STANDARD_DEVIATION 61
peri-operative blood transfusion
no
136 Participants70 Participants66 Participants
peri-operative blood transfusion
yes
6 Participants1 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
11 Participants5 Participants6 Participants
Race (NIH/OMB)
Black or African American
3 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants7 Participants4 Participants
Race (NIH/OMB)
White
117 Participants58 Participants59 Participants
Region of Enrollment
United States
142 participants71 participants71 participants
Sex: Female, Male
Female
68 Participants31 Participants37 Participants
Sex: Female, Male
Male
74 Participants40 Participants34 Participants
Surgery Indication
Cancer
30 Participants11 Participants19 Participants
Surgery Indication
inflammatory bowel disease
103 Participants55 Participants48 Participants
Surgery Indication
Other
4 Participants2 Participants2 Participants
Surgery Indication
Prolapse
5 Participants3 Participants2 Participants
Surgical drain
No
19 Participants5 Participants14 Participants
Surgical drain
Yes
123 Participants66 Participants57 Participants
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
0
108 Participants57 Participants51 Participants
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
1
18 Participants8 Participants10 Participants
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
2A
7 Participants4 Participants3 Participants
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
2B
0 Participants0 Participants0 Participants
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
2c
1 Participants0 Participants1 Participants
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
3a
4 Participants1 Participants3 Participants
The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer
3b
4 Participants1 Participants3 Participants
Total mesorectal excision
no
108 Participants53 Participants55 Participants
Total mesorectal excision
yes
34 Participants18 Participants16 Participants
Type of Surgery
IPAA
94 Participants53 Participants41 Participants
Type of Surgery
LAR
26 Participants12 Participants14 Participants
Type of Surgery
Other
16 Participants3 Participants13 Participants
Type of Surgery
Rectopexy
6 Participants3 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 710 / 71
other
Total, other adverse events
6 / 710 / 71
serious
Total, serious adverse events
0 / 710 / 71

Outcome results

Primary

Number of Participants With Acute Urinary Retention

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
24 Hour Postop Catheter RemovalNumber of Participants With Acute Urinary Retention6 Participants
72 Hour Postoperative Catheter RemovalNumber of Participants With Acute Urinary Retention7 Participants
Secondary

Number of Participants With a Symptomatic Urinary Tract Infection

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
24 Hour Postop Catheter RemovalNumber of Participants With a Symptomatic Urinary Tract Infection0 Participants
72 Hour Postoperative Catheter RemovalNumber of Participants With a Symptomatic Urinary Tract Infection8 Participants
p-value: <0.05Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026