Urinary Retention
Conditions
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
Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
5 subjects were excluded.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 142 |
Baseline characteristics
| Characteristic | Total | 24 Hour Postop Catheter Removal | 72 Hour Postoperative Catheter Removal |
|---|---|---|---|
| Age, Continuous | 44.8 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 Participants | 3 Participants | 1 Participants |
| American Society of Anesthesiologists Physical Status Classification 2 | 102 Participants | 51 Participants | 51 Participants |
| American Society of Anesthesiologists Physical Status Classification 3 | 34 Participants | 15 Participants | 19 Participants |
| American Society of Anesthesiologists Physical Status Classification 4 | 2 Participants | 2 Participants | 0 Participants |
| Body mass index | 24.1 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 loss | 192 milliliters STANDARD_DEVIATION 91 | 182 milliliters STANDARD_DEVIATION 82 | 201 milliliters STANDARD_DEVIATION 99 |
| intraoperative intravenous fluids | 2901 milliliters STANDARD_DEVIATION 192 | 2855.6 milliliters STANDARD_DEVIATION 803 | 2948.6 milliliters STANDARD_DEVIATION 857 |
| intravenous pain medications on post-operative day one | 4.7 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 score | 3.87 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 Participants | 66 Participants | 65 Participants |
| neoadjuvant chemotherapy yes | 11 Participants | 5 Participants | 6 Participants |
| OR time | 292 minutes STANDARD_DEVIATION 191 | 282 minutes STANDARD_DEVIATION 66 | 301 minutes STANDARD_DEVIATION 61 |
| peri-operative blood transfusion no | 136 Participants | 70 Participants | 66 Participants |
| peri-operative blood transfusion yes | 6 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 117 Participants | 58 Participants | 59 Participants |
| Region of Enrollment United States | 142 participants | 71 participants | 71 participants |
| Sex: Female, Male Female | 68 Participants | 31 Participants | 37 Participants |
| Sex: Female, Male Male | 74 Participants | 40 Participants | 34 Participants |
| Surgery Indication Cancer | 30 Participants | 11 Participants | 19 Participants |
| Surgery Indication inflammatory bowel disease | 103 Participants | 55 Participants | 48 Participants |
| Surgery Indication Other | 4 Participants | 2 Participants | 2 Participants |
| Surgery Indication Prolapse | 5 Participants | 3 Participants | 2 Participants |
| Surgical drain No | 19 Participants | 5 Participants | 14 Participants |
| Surgical drain Yes | 123 Participants | 66 Participants | 57 Participants |
| The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer 0 | 108 Participants | 57 Participants | 51 Participants |
| The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer 1 | 18 Participants | 8 Participants | 10 Participants |
| The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer 2A | 7 Participants | 4 Participants | 3 Participants |
| The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer 2B | 0 Participants | 0 Participants | 0 Participants |
| The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer 2c | 1 Participants | 0 Participants | 1 Participants |
| The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer 3a | 4 Participants | 1 Participants | 3 Participants |
| The tumor, node, metastasis (TNM) staging system of the combined American Joint Committee on Cancer 3b | 4 Participants | 1 Participants | 3 Participants |
| Total mesorectal excision no | 108 Participants | 53 Participants | 55 Participants |
| Total mesorectal excision yes | 34 Participants | 18 Participants | 16 Participants |
| Type of Surgery IPAA | 94 Participants | 53 Participants | 41 Participants |
| Type of Surgery LAR | 26 Participants | 12 Participants | 14 Participants |
| Type of Surgery Other | 16 Participants | 3 Participants | 13 Participants |
| Type of Surgery Rectopexy | 6 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 71 |
| other Total, other adverse events | 6 / 71 | 0 / 71 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 24 Hour Postop Catheter Removal | Number of Participants With Acute Urinary Retention | 6 Participants |
| 72 Hour Postoperative Catheter Removal | Number of Participants With Acute Urinary Retention | 7 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 24 Hour Postop Catheter Removal | Number of Participants With a Symptomatic Urinary Tract Infection | 0 Participants |
| 72 Hour Postoperative Catheter Removal | Number of Participants With a Symptomatic Urinary Tract Infection | 8 Participants |