search
Back to results

Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prazosin given 6 hours prior to catheter removal in the 24 hour group
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention focused on measuring indwelling catheter, foley, duration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

24 hour postop catheter removal

72 hour postoperative catheter removal

Arm Description

group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)

catheter removed on postoperative day 3 (72 hours postoperatively)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 29, 2013
Last Updated
January 30, 2019
Sponsor
Cedars-Sinai Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01923129
Brief Title
Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery
Official Title
Prospective Study Investigating Optimal Duration of Indwelling Urinary Catheter Following Infraperitoneal Colorectal Surgery and Role of Postoperative Alpha Blockade
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2012 (Actual)
Primary Completion Date
November 22, 2017 (Actual)
Study Completion Date
November 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
indwelling catheter, foley, duration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
24 hour postop catheter removal
Arm Type
Experimental
Arm Description
group will receive the study medication prazosin ( 1 mg PO) 6 hours prior to catheter discontinuation (24 hours postoperatively)
Arm Title
72 hour postoperative catheter removal
Arm Type
No Intervention
Arm Description
catheter removed on postoperative day 3 (72 hours postoperatively)
Intervention Type
Drug
Intervention Name(s)
Prazosin given 6 hours prior to catheter removal in the 24 hour group
Other Intervention Name(s)
Minipress, Vasoflex, Pressin, Hypovase
Intervention Description
Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Fleshner, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34184246
Citation
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Results Reference
derived
PubMed Identifier
30192326
Citation
Patel DN, Felder SI, Luu M, Daskivich TJ, N Zaghiyan K, Fleshner P. Early Urinary Catheter Removal Following Pelvic Colorectal Surgery: A Prospective, Randomized, Noninferiority Trial. Dis Colon Rectum. 2018 Oct;61(10):1180-1186. doi: 10.1097/DCR.0000000000001206.
Results Reference
derived

Learn more about this trial

Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery

We'll reach out to this number within 24 hrs