Clinical trial NCT01923129
Conditions: Urinary Retention
Keywords: indwelling catheter foley duration
Sponsor: Cedars-Sinai Medical Center
Start date: 2012-11-30; Completion date: 2017-11-22
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively) arm 2: catheter removed on postoperative day 3 (72 hours postoperatively)
Interventions: intervention 1: Prazosin given 6 hours prior to catheter removal in the 24 hour group
Intervention descriptions: intervention 1: Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)

Protocol documents:
Prot_000.pdf: 
 
 
 
 
 
PROSPECTIVE STUDY INVESTIGATING THE OPTIMAL DURATION OF INDWELLING URINARY 
CATHETER FOLLOWING INFRAPERITONEAL COLORECTAL SURGERY AND ROLE OF 
POSTOPERATIVE ALPHA-BLOCKADE 
 
 
 
 
Protocol: 
 
 
Version 3, 11/30/2012 
 
 
Lead Investigator: 
 
Phillip Fleshner, MD 
 
 
Division of Colorectal Surgery 
Cedars-Sinai Medical Center 
 
 


 
PROTOCOL 
 
Protocol No./ Title: 
Prospective study investigating the optimal duration of indwelling 
urinary catheter following infraperitoneal colorectal surgery and role of 
postoperative alpha-blockade 
Study Rationale 
The purpose of this study is to evaluate whether a postoperative pelvic 
colorectal patient can safely have an indwelling catheter removed on 
postoperative day one with the addition of a study medication, without a 
statistically significant difference in the incidence of urinary retention 
compared to the standard, accepted approach of delayed removal. 
Study Population: 
Determine the incidence of retention of two groups. A control group of 
72 hours catheterization (Group 1) to 24 hours catheterization plus 
medication (Group 2) to potentially reduce retention.  
 
Data Description:    Non-inferiority study 
pA=0.15, pB=0.15, d=0.15 (tolerance). 
We would like to test 1) If Group 2 is non-inferior to Group 1 (2 is not 
worse than 1). 
 
Power Analysis and Sample Size Calculation: 
 
A sample size for 80% power is 71 per group.  This would be a total of 
142. 
 
Two group test of equivalence in proportions  
 
 
Test significance level, 
a (one-sided) 
  0.050 
Standard proportion, pS 
0.150 
Equivalence limit difference, 
pT - pS, D0 
0.150 
Test expected proportion, pT 
0.150 
Expected difference, pT - pS, D1 
0.000 
Power (%) 
     80 
n per group 
71 
Hypothesis 
Early removal of a urinary catheter in postoperative infraperitoneal 
colorectal surgery patients will experience a similar incidence of acute 
urinary retention than delayed removal, will likely have a lower 
incidence of clinically important urinary tract infections, and experience 
improvement in quality of life measures.   
Study Design: 
Single-center, randomized, prospective study.  Patients in the 24-hour 
catheter removal group will be given 1 mg prazosin orally (per os). The 
pharmacy will be responsible for the distribution of the medication 
when indicated.  The study drug will be given 6 hours prior to catheter 
removal in Group 2 patients. 


 
 
Primary Efficacy 
Endpoint: 
Acute urinary retention (Re-catheterization) 
Secondary 
Endpoints: 
1.  Urinary tract infection (>105 CFU/mL with symptoms) 
2.  Cardiopulmonary complications 
3.  Surgical site infections 
4.  Anastomotic leaks 
5.  Quality of life 
6.  Length of postoperative stay 
7.  Volume of retained urine if re-catheterized (Bladder Scan) 
8.  Adverse side effects from treatment drug 
Safety Endpoints:  
Receiving care patient would have otherwise received. 
Sample size: 
With a sample size of 71 patients per group for a total of 142 patients, 
this study will have 80% power to detect a statistically significant 
difference between acute urinary retention in patients with urinary 
catheter removal 24 hours postoperatively compared to 72 hours 
postoperatively. 
Interim Analysis 
There will be an interim analysis after 71 patients enrolled (half the 
study group) 
Key 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 
Key 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 enter vesicle 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 
Treatment 
Regimen/ Duration: 
Patients will be assigned into one of three groups:  
Group 1-  removal of urinary catheter 72 hours postoperatively 
(Control) 
Group 2 – randomized to receive prazosin 6 hours prior to catheter 
removal and removal of urinary catheter 24 hours postoperatively 
Treatment Failure/ 
Discontinuation 
Criteria: 
Patients will be discontinued from the trial at any time as a result of any 
other event that in the opinion of the investigator warrants 
discontinuation from the trial. 
Additionally, patients will be excluded after randomization if: 
1. Catheter pulled out inadvertently; 
2. Postoperative complications requiring prolonged monitoring of 
urine output; 
3. Postoperative complications requiring early reoperation 
 


 
2.  SCHEDULE OF EVENTS 
 
 
Group 1: 
Delayed 
Catheter 
removal 
 
Visit Number 
Admission 
 
Informed Consent 
 
 
Demographics 
 
 
Height  
 
 
Medical History1 
 
 
Inclusion/ Exclusion Criteria 
Review 
 
 
Previous /Concomitant 
Medications 
 
 
Physical Exam2  
 
 
Vital Signs3 
 
 
Body Weight 
 
 
Adverse Events4  
 
 
Quality of Life Assessment5 
✓ 
 
Hospital 
Discharge 
or 
Early 
Termination Visit6 
✓ 
 
1. Medical History obtained at index admission including:  Hypertension, Lung Disease, Diabetes  
2. Comprehensive physical exam performed at index admission  
3. Vital Signs (systolic and diastolic blood pressure, heart rate, respiration rate, and temperature) at index admission. 
4. Adverse events (AEs) will be recorded at every visit post screening.  AEs will be followed until resolution. 
5. Quality of Life assessment will be performed on last hospital day prior to discharge (Appendix A) 
6. Early Termination visits are used when a patient withdraws from the study (i.e., prior to hospital discharge). 
 
 


 
 
Group 2: 
Prazosin and 
early catheter 
removal 
 
Visit Number 
Admission 
 
Informed Consent 
 
 
Demographics 
 
 
Height  
 
 
Medical History1 
 
 
Inclusion/ Exclusion Criteria 
Review 
 
 
Previous /Concomitant 
Medications 
 
 
Physical Exam2  
 
 
Vital Signs3 
 
 
Body Weight 
 
 
Adverse Events4  
 
 
Quality of Life Assessment5 
✓ 
 
Hospital 
Discharge 
or 
Early 
Termination Visit6 
✓ 
 
 
 
1. Medical History obtained at index admission including:  Hypertension, Lung Disease, Diabetes  
2. Comprehensive physical exam performed at index admission  
3. Vital Signs (systolic and diastolic blood pressure, heart rate, respiration rate, and temperature) at index admission. 
4. Adverse events (AEs) will be recorded at every visit post screening.  AEs will be followed until resolution. 
5. Quality of Life assessment will be performed on last hospital day prior to discharge (Appendix A) 
6. Early Termination visits are used when a patient withdraws from the study (i.e., prior to hospital discharge). 
 
 


 
 
 
Postoperative Data 
 
Open or Laparoscopic 
 
Reason for surgery (benign or 
cancer) 
 
Type of Surgery (LAR, APR, 
IPAA, etc) 
 
ASA Score 
 
TMN stage 
 
Metastatic Lymph Nodes 
 
Total Mesorectal Excision 
 
Level of anastomosis (<5 cm from 
anal verge) 
 
Neoadjuvant chemotherapy 
 
Neoadjuvant radiation therapy 
 
Intraoperative Fluid Volume (mL) 
 
Intraoperative Blood Loss (mL) 
 
Intraoperative/Postoperative Blood 
Transfusion 
 
Bowel preparation 
 
Diverting stoma 
 
Antibiotic therapy >24 hours 
postoperatively 
 
Morphine equivalent (mg)1 
 
Quality of Life2 
 
1. Morphine equivalent: 7 mg ≈ 1 mg hydromorphone 
2. Quality of Life: obtained on last day of hospitalization 


 
 
 
 
Group 1 
Group 2 
Endpoints 
 
 
Acute urinary retention1 (re-
catheterization) 
 
 
Bladder scan volume (mL) 
 
 
Symptomatic urinary tract 
infection2 
 
 
Cardiopulmonary complications 
 
 
Surgical site infection 
 
 
Anastomotic Leak 
 
 
Adverse side effects  
 
 
Overall complication rate 
 
 
Post-void residual (mL) 
 
 
 
 
 
 
 
 
 
 
 
1. Acute urinary retention defined as the inability to void despite urge and attempt, and/or the inability to void within 8 hours post-
removal of the catheter. 
2. Dysuria and >105 CFU/mL on urine culture 
 
 
 
 
 
 

SAP_001.pdf: 




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